Data flows are central to an increasingly large share of the economy. A wide array of products and business models—from the sharing economy and artificial intelligence to autonomous vehicles and embedded medical devices—rely on personal data. Consequently, privacy regulation leaves a large economic footprint. As with any regulatory enterprise, the key to sound data policy is striking a balance between competing interests and norms that leaves consumers better off; finding an approach that addresses privacy concerns, but also supports the benefits of technology is an increasingly complex challenge. Not only is technology continuously advancing, but individual attitudes, expectations, and participation vary greatly. New ideas and approaches to privacy must be identified and developed at the same pace and with the same focus as the technologies they address.
This year’s symposium will include panels on Unfairness under Section 5: Unpacking “Substantial Injury”, Conceptualizing the Benefits and Costs from Data Flows, and The Law and Economics of Data Security.
I will be presenting a draft paper, co-authored with Kristian Stout, on the FTC’s reasonableness standard in data security cases following the Commission decision in LabMD, entitled, When “Reasonable” Isn’t: The FTC’s Standard-less Data Security Standard.
Thursday, June 8, 2017
8:00 am to 3:40 pm
at George Mason University, Founders Hall (next door to the Law School)
Antitrust policy during much of the Obama Administration was a continuation of the Bush Administration’s minimal involvement in the market. However, at the end of President Obama’s term, there was a significant pivot to investigations and blocks of high profile mergers such as Halliburton-Baker Hughes, Comcast-Time Warner Cable, Staples-Office Depot, Sysco-US Foods, and Aetna-Humana and Anthem-Cigna. How will or should the new Administration analyze proposed mergers, including certain high profile deals like Walgreens-Rite Aid, AT&T-Time Warner, Inc., and DraftKings-FanDuel?
Join us for a lively luncheon panel discussion that will cover these topics and the anticipated future of antitrust enforcement.
Albert A. Foer, Founder and Senior Fellow, American Antitrust Institute
Profesor Geoffrey A. Manne, Executive Director, International Center for Law & Economics
Honorable Joshua D. Wright, Professor of Law, George Mason University School of Law
Moderator: Honorable Ronald A. Cass, Dean Emeritus, Boston University School of Law and President, Cass & Associates, PC
Next week the FCC is slated to vote on the second iteration of Chairman Wheeler’s proposed broadband privacy rules. Of course, as has become all too common, none of us outside the Commission has actually seen the proposal. But earlier this month Chairman Wheeler released a Fact Sheet that suggests some of the ways it would update the rules he initially proposed.
According to the Fact Sheet, the new proposed rules are
designed to evolve with changing technologies and encourage innovation, and are in harmony with other key privacy frameworks and principles — including those outlined by the Federal Trade Commission and the Administration’s Consumer Privacy Bill of Rights.
Unfortunately, the Chairman’s proposal appears to fall short of the mark on both counts.
As I discuss in detail in a letter filed with the Commission yesterday, despite the Chairman’s rhetoric, the rules described in the Fact Sheet fail to align with the FTC’s approach to privacy regulation embodied in its 2012 Privacy Report in at least two key ways:
First, the Fact Sheet significantly expands the scope of information that would be considered “sensitive” beyond that contemplated by the FTC. That, in turn, would impose onerous and unnecessary consumer consent obligations on commonplace uses of data, undermining consumer welfare, depriving consumers of information and access to new products and services, and restricting competition.
Second, unlike the FTC’s framework, the proposal described by the Fact Sheet ignores the crucial role of “context” in determining the appropriate level of consumer choice before affected companies may use consumer data. Instead, the Fact Sheet takes a rigid, acontextual approach that would stifle innovation and harm consumers.
The Chairman’s proposal moves far beyond the FTC’s definition of “sensitive” information requiring “opt-in” consent
The FTC’s privacy guidance is, in its design at least, appropriately flexible, aimed at balancing the immense benefits of information flows with sensible consumer protections. Thus it eschews an “inflexible list of specific practices” that would automatically trigger onerous consent obligations and “risk undermining companies’ incentives to innovate and develop new products and services….”
Under the FTC’s regime, depending on the context in which it is used (on which see the next section, below), the sensitivity of data delineates the difference between data uses that require “express affirmative” (opt-in) consent and those that do not (requiring only “other protections” short of opt-in consent — e.g., opt-out).
Because the distinction is so important — because opt-in consent is much more likely to staunch data flows — the FTC endeavors to provide guidance as to what data should be considered sensitive, and to cabin the scope of activities requiring opt-in consent. Thus, the FTC explains that “information about children, financial and health information, Social Security numbers, and precise geolocation data [should be treated as] sensitive.” But beyond those instances, the FTC doesn’t consider any other type of data as inherently sensitive.
By contrast, and without explanation, Chairman Wheeler’s Fact Sheet significantly expands what constitutes “sensitive” information requiring “opt-in” consent by adding “web browsing history,” “app usage history,” and “the content of communications” to the list of categories of data deemed sensitive in all cases.
By treating some of the most common and important categories of data as always “sensitive,” and by making the sensitivity of data the sole determinant for opt-in consent, the Chairman’s proposal would make it almost impossible for ISPs to make routine (to say nothing of innovative), appropriate, and productive uses of data comparable to those undertaken by virtually every major Internet company. This goes well beyond anything contemplated by the FTC — with no evidence of any corresponding benefit to consumers and with obvious harm to competition, innovation, and the overall economy online.
And because the Chairman’s proposal would impose these inappropriate and costly restrictions only on ISPs, it would create a barrier to competition by ISPs in other platform markets, without offering a defensible consumer protection rationale to justify either the disparate treatment or the restriction on competition.
“Opt-in” offers no greater privacy protection than allowing consumers to “opt-out”…, yet it imposes significantly higher costs on consumers, businesses, and the economy.
Not surprisingly, these costs fall disproportionately on the relatively poor and the less technology-literate. In the former case, opt-in requirements may deter companies from offering services at all, even to people who would make a very different trade-off between privacy and monetary price. In the latter case, because an initial decision to opt-in must be taken in relative ignorance, users without much experience to guide their decisions will face effectively higher decision-making costs than more knowledgeable users.
The Chairman’s proposal ignores the central role of context in the FTC’s privacy framework
In part for these reasons, central to the FTC’s more flexible framework is the establishment of a sort of “safe harbor” for data uses where the benefits clearly exceed the costs and consumer consent may be inferred:
Companies do not need to provide choice before collecting and using consumer data for practices that are consistent with the context of the transaction or the company’s relationship with the consumer….
Thus for many straightforward uses of data, the “context of the transaction,” not the asserted “sensitivity” of the underlying data, is the threshold question in evaluating the need for consumer choice in the FTC’s framework.
Chairman Wheeler’s Fact Sheet, by contrast, ignores this central role of context in its analysis. Instead, it focuses solely on data sensitivity, claiming that doing so is “in line with customer expectations.”
But this is inconsistent with the FTC’s approach.
In fact, the FTC’s framework explicitly rejects a pure “consumer expectations” standard:
Rather than relying solely upon the inherently subjective test of consumer expectations, the… standard focuses on more objective factors related to the consumer’s relationship with a business.
And while everyone agrees that sensitivity is a key part of pegging privacy regulation to actual consumer and corporate relationships, the FTC also recognizes that the importance of the sensitivity of the underlying data varies with the context in which it is used. Or, in the words of the White House’s 2012 Consumer Data Privacy in a Networked World Report (introducing its Consumer Privacy Bill of Rights), “[c]ontext should shape the balance and relative emphasis of particular principles” guiding the regulation of privacy.
By contrast, Chairman Wheeler’s “sensitivity-determines-consumer-expectations” framing is a transparent attempt to claim fealty to the FTC’s (and the Administration’s) privacy standards while actually implementing a privacy regime that is flatly inconsistent with them.
The FTC’s approach isn’t perfect, but that’s no excuse to double down on its failings
The FTC’s privacy guidance, and even more so its privacy enforcement practices under Section 5, are far from perfect. The FTC should be commended for its acknowledgement that consumers’ privacy preferences and companies’ uses of data will change over time, and that there are trade-offs inherent in imposing any constraints on the flow of information. But even the FTC fails to actually assess the magnitude of the costs and benefits of, and the deep complexities involved in, the trade-off, and puts an unjustified thumb on the scale in favor of limiting data use.
But that’s no excuse for Chairman Wheeler to ignore what the FTC gets right, and to double down on its failings. Based on the Fact Sheet (and the initial NPRM), it’s a virtual certainty that the Chairman’s proposal doesn’t heed the FTC’s refreshing call for humility and flexibility regarding the application of privacy rules to ISPs (and other Internet platforms):
These are complex and rapidly evolving areas, and more work should be done to learn about the practices of all large platform providers, their technical capabilities with respect to consumer data, and their current and expected uses of such data.
The rhetoric of the Chairman’s Fact Sheet is correct: the FCC should in fact conform its approach to privacy to the framework established by the FTC. Unfortunately, the reality of the Fact Sheet simply doesn’t comport with its rhetoric.
As the FCC’s vote on the Chairman’s proposal rapidly nears, and in light of its significant defects, we can only hope that the rest of the Commission refrains from reflexively adopting the proposed regime, and works to ensure that these problematic deviations from the FTC’s framework are addressed before moving forward.
Section 5(a)(2) of the Federal Trade Commission (FTC) Act authorizes the FTC to “prevent persons, partnerships, or corporations, except . . . common carriers subject to the Acts to regulate commerce . . . from using unfair methods of competition in or affecting commerce and unfair or deceptive acts or practices in or affecting commerce.” On August 29, in FTC v. AT&T, the Ninth Circuit issued a decision that exempts non-common carrier data services from U.S. Federal Trade Commission (FTC) jurisdiction, merely because they are offered by a company that has common carrier status. This case involved an FTC allegation that AT&T had “throttled” data (slowed down Internet service) for “unlimited mobile data” customers without adequate consent or disclosures, in violation of Section 5 of the FTC Act. The FTC had claimed that although AT&T mobile wireless voice services were a common carrier service, the company’s mobile wireless data services were not, and, thus, were subject to FTC oversight. Reversing a federal district court’s refusal to grant AT&T’s motion to dismiss, the Ninth Circuit concluded that “when Congress used the term ‘common carrier’ in the FTC Act, [there is no indication] it could only have meant ‘common carrier to the extent engaged in common carrier activity.’” The Ninth Circuit therefore determined that “a literal reading of the words Congress selected simply does comport with [the FTC’s] activity-based approach.” The FTC’s pending case against AT&T in the Northern District of California (which is within the Ninth Circuit) regarding alleged unfair and deceptive advertising of satellite services by AT&T subsidiary DIRECTTV (see here) could be affected by this decision.
The Ninth Circuit’s AT&T holding threatens to further extend the FCC’s jurisdictional reach at the expense of the FTC. It comes on the heels of the divided D.C. Circuit’s benighted and ill-reasoned decision (see here) upholding the FCC’s “Open Internet Order,” including its decision to reclassify Internet broadband service as a common carrier service. That decision subjects broadband service to heavy-handed and costly FCC “consumer protection” regulation, including in the area of privacy. The FCC’s overly intrusive approach stands in marked contrast to the economic efficiency considerations (albeit not always perfectly applied) that underlie FTC consumer protection mode of analysis. As I explained in a May 2015 Heritage Foundation Legal Memorandum, the FTC’s highly structured, analytic, fact-based methodology, combined with its vast experience in privacy and data security investigations, make it a far better candidate than the FCC to address competition and consumer protection problems in the area of broadband.
I argued in this space in March 2016 that, should the D.C. Circuit uphold the FCC’s Open Internet Order, Congress should carefully consider whether to strip the FCC of regulatory authority in this area (including, of course, privacy practices) and reassign it to the FTC. The D.C. Circuit’s decision upholding that Order, combined with the Ninth Circuit’s latest ruling, makes the case for potential action by the next Congress even more urgent.
While it is at it, the next Congress should also weigh whether to repeal the FTC’s common carrier exemption, as well as all special exemptions for specified categories of institutions, such as banks, savings and loans, and federal credit unions (see here). In so doing, Congress might also do away with the Consumer Financial Protection Bureau, an unaccountable bureaucracy whose consumer protection regulatory responsibilities should cease (see my February 2016 Heritage Legal Memorandum here).
Finally, as Heritage Foundation scholars have urged, Congress should look into enacting additional regulatory reform legislation, such as requiring congressional approval of new major regulations issued by agencies (including financial services regulators) and subjecting “independent” agencies (including the FCC) to executive branch regulatory review.
In recent years much ink has been spilled on the problem of online privacy breaches, involving the unauthorized use of personal information transmitted over the Internet. Internet privacy concerns are warranted. According to a 2016 National Telecommunications and Information Administration survey of Internet-using households, 19 percent of such households (representing nearly 19 million households) reported that they had been affected by an online security breach, identity theft, or similar malicious activity during the 12 months prior to the July 2015 survey. Security breaches appear to be more common among the most intensive Internet-using households – 31 percent of those using at least five different types of online devices suffered such breaches. Security breach statistics, of course, do not directly measure the consumer welfare losses attributable to the unauthorized use of personal data that consumers supply to Internet service providers and to the websites which they visit.
What is the correct overall approach government should take in dealing with Internet privacy problems? In addressing this question, it is important to focus substantial attention on the effects of online privacy regulation on economic welfare. In particular, policies should aim at addressing Internet privacy problems in a manner that does not unduly harm the private sector or deny opportunities to consumers who are not being harmed. The U.S. Federal Trade Commission (FTC), the federal government’s primary consumer protection agency, has been the principal federal regulator of online privacy practices. Very recently, however, the U.S. Federal Communications Commission (FCC) has asserted the authority to regulate the privacy practices of broadband Internet service providers, and is proposing an extremely burdensome approach to such regulation that would, if implemented, have harmful economic consequences.
[U]nfairness establishes a baseline prohibition on practices that the overwhelming majority of consumers would never knowingly approve. Above that baseline, consumers remain free to find providers that match their preferences, and our deception authority governs those arrangements. . . . The FTC’s case-by-case enforcement of our unfairness authority shapes our baseline privacy practices. Like the common law, this incremental approach has proven both relatively predictable and adaptable as new technologies and business models emerge.
Or it was in good shape. Unfortunately, on April 1, 2016, the Federal Communications Commission (FCC) decided to inject itself into “privacy space” by issuing a Notice of Proposed Rulemaking entitled “Protecting the Privacy of Customers of Broadband and Other Telecommunications Services.” This “Privacy NPRM” sets forth detailed rules that, if adopted, would impose onerous privacy obligations on “Broadband Internet Access Service” (BIAS) Providers, the firms that provide the cables, wires, and telecommunications equipment through which Internet traffic flows – primarily cable (Comcast, for example) and telephone (Verizon, for example) companies. The Privacy NPRM reclassifies BIAS provision as a “common carrier” service, thereby totally precluding the FTC from regulating BIAS Providers’ privacy practices (since the FTC is barred by law from regulating common carriers, under 15 U.S. Code § 45(a)(2)). Put simply, the NPRM required BIAS Providers “to obtain express consent in advance of practically every use of a customer[s] data”, without regard to the effects of such a requirement on economic welfare. All other purveyors of Internet services, however – in particular, the large numbers of “edge providers” that generate Internet content and services (Google, Amazon, and Facebook, for example) – are exempt from the new FCC regulatory requirements. In short, the Privacy NPRM establishes a two-tier privacy regulatory system, with BIAS Providers subject to tight FCC privacy rules, while all other Internet service firms are subject to more nuanced, case-by-case, effects-based evaluation of their privacy practices by the FTC. This disparate regulatory approach is peculiar (if not wholly illogical), since edge providers in general have greater access than BIAS Providers to consumers’ non-public information, and thus may appear to pose a greater threat to consumers’ interest in privacy.
The FCC’s proposal to regulate BIAS Providers’ privacy practices represents bad law and horrible economic policy. First, it undermines the rule of law by extending the FCC’s authority beyond its congressional mandate. It does this by basing its regulation of a huge universe of information exchanges on Section 222 of the Telecommunications Act of 1996, a narrow provision aimed at a very limited type of customer-related data obtained in connection with old-style voice telephony transmissions. This is egregious regulatory overreach. Second, if implemented, it will harm consumers, producers, and the overall economic by imposing a set of sweeping opt-in consent requirements on BIAS Providers, without regard to private sector burdens or actual consumer welfare (see here); by reducing BIAS Provider revenues and thereby dampening investment that is vital to the continued growth of and innovation in Internet-related industries (see here); by reducing the ability of BIAS Providers to provide welfare-enhancing competitive pressure on providers on Internet edge providers (see here); and by raising consumer prices for Internet services and deny discount programs desired by consumers (see here).
What’s worse, the FCC’s proposed involvement in online privacy oversight comes at a time of increased Internet privacy regulation by foreign countries, much of it highly intrusive and lacking in economic sophistication. A particularly noteworthy effort to clarify cross-national legal standards is the Privacy Shield, a 2016 United States – European Union agreement that establishes regulatory online privacy protection norms, backed by FTC enforcement, that U.S. companies transmitting data into Europe may choose to accept on a voluntary basis. (If they do not accede to the Shield, they may be subject to uncertain and heavy-handed European sanctions.) The Privacy NPRM, if implemented, will create an additional concern for BIAS Providers, since they will have to evaluate the implications of new FCC regulation (rather than simply rely on FTC oversight) in deciding whether to opt in to the Shield’s standards and obligations.
In sum, the FCC’s Privacy NPRM would, if implemented, harm consumers and producers, slow innovation, and offend the rule of law. This prompts four recommendations.
The FCC should withdraw the NPRM and leave it to the FTC to oversee all online privacy practices, under its Section 5 unfairness and deception authority. The adoption of the Privacy Shield, which designates the FTC as the responsible American privacy oversight agency, further strengthens the case against FCC regulation in this area.
Moreover, the FTC should borrow a page from former FTC Commissioner Joshua Wright by implementing an “economic approach” to privacy. Under such an approach:
o FTC economists would help make the Commission a privacy “thought leader” by developing a rigorous academic research agenda on the economics of privacy, featuring the economic evaluation of industry sectors and practices;
o FTC economists would report independently to the FTC about proposed privacy-related enforcement initiatives; and
o the FTC would publish the views of its Bureau of Economics in all privacy-related consent decrees that are placed on the public record.
The FTC should encourage the European Commission and other foreign regulators to take into account the economics of privacy in developing their privacy regulatory policies. In so doing, it should emphasize that innovation is harmed, the beneficial development of the Internet is slowed, and consumer welfare and rights are undermined through highly prescriptive regulation in this area (well-intentioned though it may be). Relatedly, the FTC and other U.S. Government negotiators should argue against adoption of a “one-size-fits-all” global privacy regulation framework. Such a global framework could harmfully freeze into place over-regulatory policies and preclude beneficial experimentation in alternative forms of “lighter-touch” regulation and enforcement.
While no panacea, these recommendations would help deter (or, at least, constrain) the economically harmful government micromanagement of businesses’ privacy practices, in the United States and abroad.
Brand drug manufacturers are no strangers to antitrust accusations when it comes to their complicated relationship with generic competitors — most obviously with respect to reverse payment settlements. But the massive and massively complex regulatory scheme under which drugs are regulated has provided other opportunities for regulatory legerdemain with potentially anticompetitive effect, as well.
In particular, some FTC Commissioners have raised concerns that brand drug companies have been taking advantage of an FDA drug safety program — the Risk Evaluation and Mitigation Strategies program, or “REMS” — to delay or prevent generic entry.
Drugs subject to a REMS restricted distribution program are difficult to obtain through market channels and not otherwise readily available, even for would-be generic manufacturers that need samples in order to perform the tests required to receive FDA approval to market their products. REMS allows (requires, in fact) brand manufacturers to restrict the distribution of certain drugs that present safety or abuse risks, creating an opportunity for branded drug manufacturers to take advantage of imprecise regulatory requirements by inappropriately limiting access by generic manufacturers.
The FTC has not (yet) brought an enforcement action, but it has opened several investigations, and filed an amicus brief in a private-party litigation. Generic drug companies have filed several antitrust claims against branded drug companies and raised concerns with the FDA.
The problem, however, is that even if these companies are using REMS to delay generics, such a practice makes for a terrible antitrust case. Not only does the existence of a regulatory scheme arguably set Trinko squarely in the way of a successful antitrust case, but the sort of refusal to deal claims at issue here (as in Trinko) are rightly difficult to win because, as the DOJ’s Section 2 Report notes, “there likely are few circumstances where forced sharing would help consumers in the long run.”
But just because there isn’t a viable antitrust case doesn’t mean there isn’t still a competition problem. But in this case, it’s a problem of regulatory failure. Companies rationally take advantage of poorly written federal laws and regulations in order to tilt the market to their own advantage. It’s no less problematic for the market, but its solution is much more straightforward, if politically more difficult.
Thus it’s heartening to see that Senator Mike Lee (R-UT), along with three of his colleagues (Patrick Leahy (D-VT), Chuck Grassley (R-IA), and Amy Klobuchar (D-MN)), has proposed a novel but efficient way to correct these bureaucracy-generated distortions in the pharmaceutical market without resorting to the “blunt instrument” of antitrust law. As the bill notes:
While the antitrust laws may address actions by license holders who impede the prompt negotiation and development on commercially reasonable terms of a single, shared system of elements to assure safe use, a more tailored legal pathway would help ensure that license holders negotiate such agreements in good faith and in a timely manner, facilitating competition in the marketplace for drugs and biological products.
The legislative solution put forward by the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 targets the right culprit: the poor regulatory drafting that permits possibly anticompetitive conduct to take place. Moreover, the bill refrains from creating a per se rule, instead implementing several features that should still enable brand manufacturers to legitimately restrict access to drug samples when appropriate.
In essence, Senator Lee’s bill introduces a third party (in this case, the Secretary of Health and Human Services) who is capable of determining whether an eligible generic manufacturer is able to comply with REMS restrictions — thus bypassing any bias on the part of the brand manufacturer. Where the Secretary determines that a generic firm meets the REMS requirements, the bill also creates a narrow cause of action for this narrow class of plaintiffs, allowing suits against certain brand manufacturers who — despite the prohibition on using REMS to delay generics — nevertheless misuse the process to delay competitive entry.
Background on REMS
The REMS program was introduced as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Following the withdrawal of Vioxx, an arthritis pain reliever, from the market because of a post-approval linkage of the drug to heart attacks, the FDA was under considerable fire, and there was a serious risk that fewer and fewer net beneficial drugs would be approved. The REMS program was introduced by Congress as a mechanism to ensure that society could reap the benefits from particularly risky drugs and biologics — rather than the FDA preventing them from entering the market at all. It accomplishes this by ensuring (among other things) that brands and generics adopt appropriate safety protocols for distribution and use of drugs — particularly when a drug has the potential to cause serious side effects, or has an unusually high abuse profile.
The FDA-determined REMS protocols can range from the simple (e.g., requiring a medication guide or a package insert about potential risks) to the more burdensome (including restrictions on a drug’s sale and distribution, or what the FDA calls “Elements to Assure Safe Use” (“ETASU”)). Most relevant here, the REMS process seems to allow brands considerable leeway to determine whether generic manufacturers are compliant or able to comply with ETASUs. Given this discretion, it is no surprise that brand manufacturers may be tempted to block competition by citing “safety concerns.”
Although the FDA specifically forbids the use of REMS to block lower-cost, generic alternatives from entering the market (of course), almost immediately following the law’s enactment, certain less-scrupulous branded pharmaceutical companies began using REMS for just that purpose (also, of course).
To enter into pharmaceutical markets that no longer have any underlying IP protections, manufactures must submit to the FDA an Abbreviated New Drug Application (ANDA) for a generic, or an Abbreviated Biologic License Application (ABLA) for a biosimilar, of the brand drug. The purpose is to prove to the FDA that the competing product is as safe and effective as the branded reference product. In order to perform the testing sufficient to prove efficacy and safety, generic and biosimilar drug manufacturers must acquire a sample (many samples, in fact) of the reference product they are trying to replicate.
For the narrow class of dangerous or highly abused drugs, generic manufacturers are forced to comply with any REMS restrictions placed upon the brand manufacturer — even when the terms require the brand manufacturer to tightly control the distribution of its product.
And therein lies the problem. Because the brand manufacturer controls access to its products, it can refuse to provide the needed samples, using REMS as an excuse. In theory, it may be true in certain cases that a brand manufacturer is justified in refusing to distribute samples of its product, of course; some would-be generic manufacturers certainly may not meet the requisite standards for safety and security.
But in practice it turns out that most of the (known) examples of brands refusing to provide samples happen across the board — they preclude essentially all generic competition, not just the few firms that might have insufficient safeguards. It’s extremely difficult to justify such refusals on the basis of a generic manufacturer’s suitability when all would-be generic competitors are denied access, including well-established, high-quality manufacturers.
But, for a few brand manufacturers, at least, that seems to be how the REMS program is implemented. Thus, for example, Jon Haas, director of patient access at Turing Pharmaceuticals, referred to the practice of denying generics samples this way:
Most likely I would block that purchase… We spent a lot of money for this drug. We would like to do our best to avoid generic competition. It’s inevitable. They seem to figure out a way [to make generics], no matter what. But I’m certainly not going to make it easier for them. We’re spending millions and millions in research to find a better Daraprim, if you will.
As currently drafted, the REMS program gives branded manufacturers the ability to limit competition by stringing along negotiations for product samples for months, if not years. Although access to a few samples for testing is seemingly such a small, trivial thing, the ability to block this access allows a brand manufacturer to limit competition (at least from bioequivalent and generic drugs; obviously competition between competing branded drugs remains).
And even if a generic competitor manages to get ahold of samples, the law creates an additional wrinkle by imposing a requirement that brand and generic manufacturers enter into a single shared REMS plan for bioequivalent and generic drugs. But negotiating the particulars of the single, shared program can drag on for years. Consequently, even when a generic manufacturer has received the necessary samples, performed the requisite testing, and been approved by the FDA to sell a competing drug, it still may effectively be barred from entering the marketplace because of REMS.
The number of drugs covered by REMS is small: fewer than 100 in a universe of several thousand FDA-approved drugs. And the number of these alleged to be subject to abuse is much smaller still. Nonetheless, abuse of this regulation by certain brand manufacturers has likely limited competition and increased prices.
Antitrust is not the answer
Whether the complex, underlying regulatory scheme that allocates the relative rights of brands and generics — and that balances safety against access — gets the balance correct or not is an open question, to be sure. But given the regulatory framework we have and the perceived need for some sort of safety controls around access to samples and for shared REMS plans, the law should at least work to do what it intends, without creating an opportunity for harmful manipulation. Yet it appears that the ambiguity of the current law has allowed some brand manufacturers to exploit these safety protections to limit competition.
As noted above, some are quite keen to make this an antitrust issue. But, as also noted, antitrust is a poor fit for handling such abuses.
First, antitrust law has an uneasy relationship with other regulatory schemes. Not least because of Trinko, it is a tough case to make that brand manufacturers are violating antitrust laws when they rely upon legal obligations under a safety program that is essentially designed to limit generic entry on safety grounds. The issue is all the more properly removed from the realm of antitrust enforcement given that the problem is actually one of regulatory failure, not market failure.
Second, antitrust law doesn’t impose a duty to deal with rivals except in very limited circumstances. In Trinko, for example, the Court rejected the invitation to extend a duty to deal to situations where an existing, voluntary economic relationship wasn’t terminated. By definition this is unlikely to be the case here where the alleged refusal to deal is what prevents the generic from entering the market in the first place. The logic behind Trinko (and a host of other cases that have limited competitors’ obligations to assist their rivals) was to restrict duty to deal cases to those rare circumstances where it reliably leads to long-term competitive harm — not where it amounts to a perfectly legitimate effort to compete without giving rivals a leg-up.
But antitrust is such a powerful tool and such a flexible “catch-all” regulation, that there are always efforts to thwart reasonable limits on its use. As severalofus at TOTM have written about at length in the past, former FTC Commissioner Rosch and former FTC Chairman Leibowitz were vocal proponents of using Section 5 of the FTC Act to circumvent sensible judicial limits on making out and winning antitrust claims, arguing that the limits were meant only for private plaintiffs — not (implicitly infallible) government enforcers. Although no one at the FTC has yet (publicly) suggested bringing a REMS case as a standalone Section 5 case, such a case would be consistent with the sorts of theories that animated past standalone Section 5 cases.
Again, this approach serves as an end-run around the reasonable judicial constraints that evolved as a result of judges actually examining the facts of individual cases over time, and is a misguided way of dealing with what is, after all, fundamentally a regulatory design problem.
The CREATES Act
Senator Lee’s bill, on the other hand, aims to solve the problem with a more straightforward approach by improving the existing regulatory mechanism and by adding a limited judicial remedy to incentivize compliance under the amended regulatory scheme. In summary:
The bill creates a cause of action for a refusal to deal only where plaintiff can prove, by a preponderance of the evidence, that certain well-defined conditions are met.
For samples, if a drug is not covered by a REMS, or if the generic manufacturer is specifically authorized, then the generic can sue if it doesn’t receive sufficient quantities of samples on commercially reasonable terms. This is not a per se offense subject to outsized antitrust damages. Instead, the remedy is a limited injunction ensuring the sale of samples on commercially reasonable terms, reasonable attorneys’ fees, and a monetary fine limited to revenue earned from sale of the drug during the refusal period.
The bill also gives a brand manufacturer an affirmative defense if it can prove by a preponderance of the evidence that, regardless of its own refusal to supply them, samples were nevertheless available elsewhere on commercially reasonable terms, or where the brand manufacturer is unable to supply the samples because it does not actually produce or market the drug.
In order to deal with the REMS process problems, the bill creates similar rights with similar limitations when the license holders and generics cannot come to an agreement about a shared REMS on commercially reasonable terms within 120 days of first contact by an eligible developer.
The bill also explicitly limits brand manufacturers’ liability for claims “arising out of the failure of an [eligible generic manufacturer] to follow adequate safeguards,” thus removing one of the (perfectly legitimate) objections to the bill pressed by brand manufacturers.
The primary remedy is limited, injunctive relief to end the delay. And brands are protected from frivolous litigation by an affirmative defense under which they need only show that the product is available for purchase on reasonable terms elsewhere. Damages are similarly limited and are awarded only if a court finds that the brand manufacturer lacked a legitimate business justification for its conduct (which, under the drug safety regime, means essentially a reasonable belief that its own REMS plan would be violated by dealing with the generic entrant). And monetary damages do not include punitive damages.
Finally, the proposed bill completely avoids the question of whether antitrust laws are applicable, leaving that possibility open to determination by courts — as is appropriate. Moreover, by establishing even more clearly the comprehensive regulatory regime governing potential generic entrants’ access to dangerous drugs, the bill would, given the holding in Trinko, probably make application of antitrust laws here considerably less likely.
Ultimately Senator Lee’s bill is a well-thought-out and targeted fix to an imperfect regulation that seems to be facilitating anticompetitive conduct by a few bad actors. It does so without trampling on the courts’ well-established antitrust jurisprudence, and without imposing excessive cost or risk on the majority of brand manufacturers that behave perfectly appropriately under the law.
Earlier this week I testified before the U.S. House Subcommittee on Commerce, Manufacturing, and Trade regarding several proposed FTC reform bills.
You can find my written testimony here. That testimony was drawn from a 100 page report, authored by Berin Szoka and me, entitled “The Federal Trade Commission: Restoring Congressional Oversight of the Second National Legislature — An Analysis of Proposed Legislation.” In the report we assess 9 of the 17 proposed reform bills in great detail, and offer a host of suggested amendments or additional reform proposals that, we believe, would help make the FTC more accountable to the courts. As I discuss in my oral remarks, that judicial oversight was part of the original plan for the Commission, and an essential part of ensuring that its immense discretion is effectively directed toward protecting consumers as technology and society evolve around it.
The report is “Report 2.0” of the FTC: Technology & Reform Project, which was convened by the International Center for Law & Economics and TechFreedom with an inaugural conference in 2013. Report 1.0 lays out some background on the FTC and its institutional dynamics, identifies the areas of possible reform at the agency, and suggests the key questions/issues each of them raises.
The text of my oral remarks follow, or, if you prefer, you can watch them here:
Chairman Burgess, Ranking Member Schakowsky, and Members of the Subcommittee, thank you for the opportunity to appear before you today.
I’m Executive Director of the International Center for Law & Economics, a non-profit, non-partisan research center. I’m a former law professor, I used to work at Microsoft, and I had what a colleague once called the most illustrious FTC career ever — because, at approximately 2 weeks, it was probably the shortest.
I’m not typically one to advocate active engagement by Congress in anything (no offense). But the FTC is different.
Despite Congressional reforms, the FTC remains the closest thing we have to a second national legislature. Its jurisdiction covers nearly every company in America. Section 5, at its heart, runs just 20 words — leaving the Commission enormous discretion to make policy decisions that are essentially legislative.
The courts were supposed to keep the agency on course. But they haven’t. As Former Chairman Muris has written, “the agency has… traditionally been beyond judicial control.”
So it’s up to Congress to monitor the FTC’s processes, and tweak them when the FTC goes off course, which is inevitable.
This isn’t a condemnation of the FTC’s dedicated staff. Rather, this one way ratchet of ever-expanding discretion is simply the nature of the beast.
Yet too many people lionize the status quo. They see any effort to change the agency from the outside as an affront. It’s as if Congress was struck by a bolt of lightning in 1914 and the Perfect Platonic Agency sprang forth.
But in the real world, an agency with massive scope and discretion needs oversight — and feedback on how its legal doctrines evolve.
So why don’t the courts play that role? Companies essentially always settle with the FTC because of its exceptionally broad investigatory powers, its relatively weak standard for voting out complaints, and the fact that those decisions effectively aren’t reviewable in federal court.
Then there’s the fact that the FTC sits in judgment of its own prosecutions. So even if a company doesn’t settle and actually wins before the ALJ, FTC staff still wins 100% of the time before the full Commission.
Able though FTC staffers are, this can’t be from sheer skill alone.
Whether by design or by neglect, the FTC has become, as Chairman Muris again described it, “a largely unconstrained agency.”
Please understand: I say this out of love. To paraphrase Churchill, the FTC is the “worst form of regulatory agency — except for all the others.”
Eventually Congress had to course-correct the agency — to fix the disconnect and to apply its own pressure to refocus Section 5 doctrine.
So a heavily Democratic Congress pressured the Commission to adopt the Unfairness Policy Statement in 1980. The FTC promised to restrain itself by balancing the perceived benefits of its unfairness actions against the costs, and not acting when injury is insignificant or consumers could have reasonably avoided injury on their own. It is, inherently, an economic calculus.
But while the Commission pays lip service to the test, you’d be hard-pressed to identify how (or whether) it’s implemented it in practice. Meanwhile, the agency has essentially nullified the “materiality” requirement that it volunteered in its 1983 Deception Policy Statement.
Worst of all, Congress failed to anticipate that the FTC would resume exercising its vast discretion through what it now proudly calls its “common law of consent decrees” in data security cases.
Combined with a flurry of recommended best practices in reports that function as quasi-rulemakings, these settlements have enabled the FTC to circumvent both Congressional rulemaking reforms and meaningful oversight by the courts.
The FTC’s data security settlements aren’t an evolving common law. They’re a static statement of “reasonable” practices, repeated about 55 times over the past 14 years. At this point, it’s reasonable to assume that they apply to all circumstances — much like a rule (which is, more or less, the opposite of the common law).
Congressman Pompeo’s SHIELD Act would help curtail this practice, especially if amended to include consent orders and reports. It would also help focus the Commission on the actual elements of the Unfairness Policy Statement — which should be codified through Congressman Mullins’ SURE Act.
Significantly, only one data security case has actually come before an Article III court. The FTC trumpets Wyndham as an out-and-out win. But it wasn’t. In fact, the court agreed with Wyndham on the crucial point that prior consent orders were of little use in trying to understand the requirements of Section 5.
More recently the FTC suffered another rebuke. While it won its product design suit against Amazon, the Court rejected the Commission’s “fencing in” request to permanently hover over the company and micromanage practices that Amazon had already ended.
As the FTC grapples with such cutting-edge legal issues, it’s drifting away from the balance it promised Congress.
But Congress can’t fix these problems simply by telling the FTC to take its bedrock policy statements more seriously. Instead it must regularly reassess the process that’s allowed the FTC to avoid meaningful judicial scrutiny. The FTC requires significant course correction if its model is to move closer to a true “common law.”
Yesterday a federal district court in Washington state granted the FTC’s motion for summary judgment against Amazon in FTC v. Amazon — the case alleging unfair trade practices in Amazon’s design of the in-app purchases interface for apps available in its mobile app store. The headlines score the decision as a loss for Amazon, and the FTC, of course, claims victory. But the court also granted Amazon’s motion for partial summary judgment on a significant aspect of the case, and the Commission’s win may be decidedly pyrrhic.
While the district court (very wrongly, in my view) essentially followed the FTC in deciding that a well-designed user experience doesn’t count as a consumer benefit for assessing substantial harm under the FTC Act, it rejected the Commission’s request for a permanent injunction against Amazon. It also called into question the FTC’s calculation of monetary damages. These last two may be huge.
The FTC may have “won” the case, but it’s becoming increasingly apparent why it doesn’t want to take these cases to trial. First in Wyndham, and now in Amazon, courts have begun to chip away at the FTC’s expansive Section 5 discretion, even while handing the agency nominal victories.
The Good News
The FTC largely escapes judicial oversight in cases like these because its targets almost always settle (Amazon is a rare exception). These settlements — consent orders — typically impose detailed 20-year injunctions and give the FTC ongoing oversight of the companies’ conduct for the same period. The agency has wielded the threat of these consent orders as a powerful tool to micromanage tech companies, and it currently has at least one consent order in place with Twitter, Google, Apple, Facebook and several others.
As I wrote in a WSJ op-ed on these troubling consent orders:
The FTC prefers consent orders because they extend the commission’s authority with little judicial oversight, but they are too blunt an instrument for regulating a technology company. For the next 20 years, if the FTC decides that Google’s product design or billing practices don’t provide “express, informed consent,” the FTC could declare Google in violation of the new consent decree. The FTC could then impose huge penalties—tens or even hundreds of millions of dollars—without establishing that any consumer had actually been harmed.
Yesterday’s decision makes that outcome less likely. Companies will be much less willing to succumb to the FTC’s 20-year oversight demands if they know that courts may refuse the FTC’s injunction request and accept companies’ own, independent and market-driven efforts to address consumer concerns — without any special regulatory micromanagement.
In the same vein, while the court did find that Amazon was liable for repayment of unauthorized charges made without “express, informed authorization,” it also found the FTC’s monetary damages calculation questionable and asked for further briefing on the appropriate amount. If, as seems likely, it ultimately refuses to simply accept the FTC’s damages claims, that, too, will take some of the wind out of the FTC’s sails. Other companies have settled with the FTC and agreed to 20-year consent decrees in part, presumably, because of the threat of excessive damages if they litigate. That, too, is now less likely to happen.
Collectively, these holdings should help to force the FTC to better target its complaints to cases of still-ongoing and truly-harmful practices — the things the FTC Act was really meant to address, like actual fraud. Tech companies trying to navigate ever-changing competitive waters by carefully constructing their user interfaces and payment mechanisms (among other things) shouldn’t be treated the same way as fraudulent phishing scams.
The Bad News
The court’s other key holding is problematic, however. In essence, the court, like the FTC, seems to believe that regulators are better than companies’ product managers, designers and engineers at designing app-store user interfaces:
[A] clear and conspicuous disclaimer regarding in-app purchases and request for authorization on the front-end of a customer’s process could actually prove to… be more seamless than the somewhat unpredictable password prompt formulas rolled out by Amazon.
Never mind that Amazon has undoubtedly spent tremendous resources researching and designing the user experience in its app store. And never mind that — as Amazon is certainly aware — a consumer’s experience of a product is make-or-break in the cut-throat world of online commerce, advertising and search (just ask Jet).
Instead, for the court (and the FTC), the imagined mechanism of “affirmatively seeking a customer’s authorized consent to a charge” is all benefit and no cost. Whatever design decisions may have informed the way Amazon decided to seek consent are either irrelevant, or else the user-experience benefits they confer are negligible.
Amazon has built its entire business around the “1-click” concept — which consumers love — and implemented a host of notification and security processes hewing as much as possible to that design choice, but nevertheless taking account of the sorts of issues raised by in-app purchases. Moreover — and perhaps most significantly — it has implemented an innovative and comprehensive parental control regime (including the ability to turn off all in-app purchases) — Kindle Free Time — that arguably goes well beyond anything the FTC required in its Apple consent order.
Amazon is not abdicating its obligation to act fairly under the FTC Act and to ensure that users are protected from unauthorized charges. It’s just doing so in ways that also take account of the costs such protections may impose — particularly, in this case, on the majority of Amazon customers who didn’t and wouldn’t suffer such unauthorized charges.
Amazon began offering Kindle Free Time in 2012 as an innovative solution to a problem — children’s access to apps and in-app purchases — that affects only a small subset of Amazon’s customers. To dismiss that effort without considering that Amazon might have made a perfectly reasonable judgment that balanced consumer protection and product design disregards the cost-benefit balancing required by Section 5 of the FTC Act.
Moreover, the FTC Act imposes liability for harm only when they are not “reasonably avoidable.” Kindle Free Time is an outstanding example of an innovative mechanism that allows consumers at risk of unauthorized purchases by children to “reasonably avoid” harm. The court’s and the FTC’s disregard for it is inconsistent with the statute.
The court’s willingness to reinforce the FTC’s blackboard design “expertise” (such as it is) to second guess user-interface and other design decisions made by firms competing in real markets is unfortunate. But there’s a significant silver lining. By reining in the FTC’s discretion to go after these companies as if they were common fraudsters, the court has given consumers an important victory. After all, it is consumers who otherwise bear the costs (both directly and as a result of reduced risk-taking and innovation) of the FTC’s largely unchecked ability to extract excessive concessions from its enforcement targets.
Today’s Canadian Competition Bureau (CCB) Google decision marks yet another regulator joining the chorus of competition agencies around the world that have already dismissed similar complaints relating to Google’s Search or Android businesses (including the US FTC, the Korea FTC, the Taiwan FTC, and AG offices in Texas and Ohio).
A number of courts around the world have also rejected competition complaints against the company, including courts in the US, France, the UK, Germany, and Brazil.
After an extensive, three-year investigation into Google’s business practices in Canada, the CCB
did not find sufficient evidence that Google engaged in [search manipulation, preferential treatment of Google services, syndication agreements, distribution agreements, exclusion of competitors from its YouTube mobile app, or tying of mobile ads with those on PCs and tablets] for an anti-competitive purpose, and/or that the practices resulted in a substantial lessening or prevention of competition in any relevant market.
Like the US FTC, the CCB did find fault with Google’s use of restriction on its AdWords API — but Google had already revised those terms worldwide following the FTC investigation, and has committed to the CCB to maintain the revised terms for at least another 5 years.
Other than a negative ruling from Russia’s competition agency last year in favor of Yandex — essentially “the Russian Google,” and one of only a handful of Russian tech companies of significance (surely a coincidence…) — no regulator has found against Google on the core claims brought against it.
True, investigations in a few jurisdictions, including the EU and India, are ongoing. And a Statement of Objections in the EU’s Android competition investigation appears imminent. But at some point, regulators are going to have to take a serious look at the motivations of the entities that bring complaints before wasting more investigatory resources on their behalf.
Competitor after competitor has filed complaints against Google that amount to, essentially, a claim that Google’s superior services make it too hard to compete. But competition law doesn’t require that Google or any other large firm make life easier for competitors. Without a finding of exclusionary harm/abuse of dominance (and, often, injury to consumers), this just isn’t anticompetitive conduct — it’s competition. And the overwhelming majority of competition authorities that have examined the company have agreed.
Exactly when will regulators be a little more skeptical of competitors trying to game the antitrust laws for their own advantage?
Canada joins the chorus
The Canadian decision mirrors the reasoning that regulators around the world have employed in reaching the decision that Google hasn’t engaged in anticompetitive conduct.
Two of the more important results in the CCB’s decision relate to preferential treatment of Google’s services (e.g., promotion of its own Map or Shopping results, instead of links to third-party aggregators of the same services) — the tired “search bias” claim that started all of this — and the distribution agreements that Google enters into with device manufacturers requiring inclusion of Google search as a default installation on Google Android phones.
On these key issues the CCB was unequivocal in its conclusions.
On search bias:
The Bureau sought evidence of the harm allegedly caused to market participants in Canada as a result of any alleged preferential treatment of Google’s services. The Bureau did not find adequate evidence to support the conclusion that this conduct has had an exclusionary effect on rivals, or that it has resulted in a substantial lessening or prevention of competition in a market.
And on search distribution agreements:
Google competes with other search engines for the business of hardware manufacturers and software developers. Other search engines can and do compete for these agreements so they appear as the default search engine…. Consumers can and do change the default search engine on their desktop and mobile devices if they prefer a different one to the pre-loaded default…. Google’s distribution agreements have not resulted in a substantial lessening or prevention of competition in Canada.
And here is the crucial point of the CCB’s insight (which, so far, everyone but Russia seems to appreciate): Despite breathless claims from rivals alleging they can’t compete in the face of their placement in Google’s search results, data barriers to entry, or default Google search on mobile devices, Google does actually face significant competition. Both the search bias and Android distribution claims were dismissed essentially because, whatever competitors may prefer Google do, its conduct doesn’t actually preclude access to competing services.
The True North strong and free [of meritless competitor complaints]
Exclusionary conduct must, well, exclude. But surfacing Google’s own “subjective” search results, even if they aren’t as high quality, doesn’t exclude competitors, according to the CCB and the other regulatory agencies that have also dismissed such claims. Similarly, consumers’ ability to switch search engines (“competition is just a click away,” remember), as well as OEMs’ ability to ship devices with different search engine defaults, ensure that search competitors can access consumers.
Former FTC Commissioner Josh Wright’s analysis of “search bias” in Google’s results applies with equal force to these complaints:
It is critical to recognize that bias alone is not evidence of competitive harm and it must be evaluated in the appropriate antitrust economic context of competition and consumers, rather [than] individual competitors and websites… [but these results] are not useful from an antitrust policy perspective because they erroneously—and contrary to economic theory and evidence—presume natural and procompetitive product differentiation in search rankings to be inherently harmful.
The competitors that bring complaints to antitrust authorities seek to make a demand of Google that is rarely made of any company: that it must provide access to its competitors on equal terms. But one can hardly imagine a valid antitrust complaint arising because McDonald’s refuses to sell a Whopper. The law on duties to deal is heavily circumscribed for good reason, as Josh Wright and I have pointed out:
The [US Supreme] Court [in Trinko] warned that the imposition of a duty to deal would threaten to “lessen the incentive for the monopolist, the rival, or both to invest in… economically beneficial facilities.”… Because imposition of a duty to deal with rivals threatens to decrease the incentive to innovate by creating new ways of producing goods at lower costs, satisfying consumer demand, or creating new markets altogether, courts and antitrust agencies have been reluctant to expand the duty.
Requiring Google to link to other powerful and sophisticated online search companies, or to provide them with placement on Google Android mobile devices, on the precise terms it does its own products would reduce the incentives of everyone to invest in their underlying businesses to begin with.
This is the real threat to competition. And kudos to the CCB for recognizing it.
The CCB’s investigation was certainly thorough, and its decision appears to be well-reasoned. Other regulators should take note before moving forward with yet more costly investigations.
I have small children and, like any reasonably competent parent, I take an interest in monitoring their Internet usage. In particular, I am sensitive to what ad content they are being served and which sites they visit that might try to misuse their information. My son even uses Chromebooks at his elementary school, which underscores this concern for me, as I can’t always be present to watch what he does online. However, also like any other reasonably competent parent, I trust his school and his teacher to make good choices about what he is allowed to do online when I am not there to watch him. And so it is that I am both interested in and rather perplexed by what has EFF so worked up in its FTC complaint alleging privacy “violations” in the “Google for Education” program.
EFF alleges three “unfair or deceptive” acts that would subject Google to remedies under Section 5 of the FTCA: (1) Students logged into “Google for Education” accounts have their non-educational behavior individually tracked (e.g. performing general web searches, browsing YouTube, etc.); (2) the Chromebooks distributed as part of the “Google for Education” program have the “Chrome Sync” feature turned on by default (ostensibly in a terribly diabolical effort to give students a seamless experience between using the Chromebooks at home and at school); and (3) the school administrators running particular instances of “Google for Education” have the ability to share student geolocation information with third-party websites. Each of these violations, claims EFF, violates the K-12 School Service Provider Pledge to Safeguard Student Privacy (“Pledge”) that was authored by the Future of Privacy Forum and Software & Information Industry Association, and to which Google is a signatory. According to EFF, Google included references to its signature in its “Google for Education” marketing materials, thereby creating the expectation in parents that it would adhere to the principles, failed to do so, and thus should be punished.
The TL;DR version: EFF appears to be making some simple interpretational errors — it believes that the scope of the Pledge covers any student activity and data generated while a student is logged into a Google account. As the rest of this post will (hopefully) make clear, however, the Pledge, though ambiguous, is more reasonably read as limiting Google’s obligations to instances where a student is using Google for Education apps, and does not apply to instances where the student is using non-Education apps — whether she is logged on using her Education account or not.
The key problem, as EFF sees it, is that Google “use[d] and share[d] … student personal information beyond what is needed for education.” So nice of them to settle complex business and educational decisions for the world! Who knew it was so easy to determine exactly what is needed for educational purposes!
Case in point: EFF feels that Google’s use of anonymous and aggregated student data in order to improve its education apps is not an educational purpose. Seriously? How can that not be useful for educational purposes — to improve its educational apps!?
And, according to EFF, the fact that Chrome Sync is ‘on’ by default in the Chromebooks only amplifies the harm caused by the non-Education data tracking because, when the students log in outside of school, their behavior can be correlated with their in-school behavior. Of course, this ignores the fact that the same limitations apply to the tracking — it happens only on non-Education apps. Thus, the Chrome Sync objection is somehow vaguely based on geography. The fact that Google can correlate an individual student’s viewing of a Neil DeGrasse Tyson video in a computer lab at school with her later finishing that video at home is somehow really bad (or so EFF claims).
EFF also takes issue with the fact that school administrators are allowed to turn on a setting enabling third parties to access the geolocation data of Google education apps users.
The complaint is fairly sparse on this issue — and the claim is essentially limited to the assertion that “[s]haring a student’s physical location with third parties is unquestionably sharing personal information beyond what is needed for educational purposes[.]” While it’s possible that third-parties could misuse student data, a presumption that it is per se outside of any educational use for third-parties to have geolocation access at all strikes me as unreasonable.
Geolocation data, particularly on mobile devices, could allow for any number of positive and negative uses, and without more it’s hard to really take EFF’s premature concern all that seriously. Did they conduct a study demonstrating that geolocation data can serve no educational purpose or that the feature is frequently abused? Sadly, it seems doubtful. Instead, they appear to be relying upon the rather loose definition of likely harm that we have seen in FTC actions in other contexts ( more on this problem here).
Who decides what ambiguous terms mean?
The bigger issue, however, is the ambiguity latent in the Pledge and how that ambiguity is being exploited to criticize Google. The complaint barely conceals EFF’s eagerness, and gives one the distinct feeling that the Pledge and this complaint are part of a long game. Everyone knows that Google’s entire existence revolves around the clever and innovative employment of large data sets. When Google announced that it was interested in working with schools to provide technology to students, I can only imagine how the anti-big-data-for-any-commercial-purpose crowd sat up and took notice, just waiting to pounce as soon as an opportunity, no matter how tenuous, presented itself.
EFF notes that “[u]nlike Microsoft and numerous other developers of digital curriculum and classroom management software, Google did not initially sign onto the Student Privacy Pledge with the first round of signatories when it was announced in the fall of 2014.” Apparently, it is an indictment of Google that it hesitated to adopt an external statement of privacy principles that was authored by a group that had no involvement with Google’s internal operations or business realities. EFF goes on to note that it was only after “sustained criticism” that Google “reluctantly” signed the pledge. So the company is badgered into signing a pledge that it was reluctant to sign in the first place (almost certainly for exactly these sorts of reasons), and is now being skewered by the proponents of the pledge that it was reluctant to sign. Somehow I can’t help but get the sense that this FTC complaint was drafted even before Google signed the Pledge.
According to the Pledge, Google promised to:
“Not collect, maintain, use or share student personal information beyond that needed for authorized educational/school purposes, or as authorized by the parent/student.”
“Not build a personal profile of a student other than for supporting authorized educational/school purposes or as authorized by the parent/student.”
“Not knowingly retain student personal information beyond the time period required to support the authorized educational/school purposes, or as authorized by the parent/student.”
EFF interprets “educational purpose” as anything a student does while logged into her education account, and by extension, any of the even non-educational activity will count as “student personal information.” I think that a fair reading of the Pledge undermines this position, however, and that the correct interpretation of the Pledge is that “educational purpose” and “student personal information” are more tightly coupled such that Google’s ability to collect student data is only circumscribed when the student is actually using the Google for Education Apps.
So what counts as “student personal information” in the pledge? “Student personal information” is “personally identifiable information as well as other information when it is both collected and maintained on an individual level and is linked to personally identifiable information.” Although this is fairly broad, it is limited by the definition of “Educational/School purposes” which are “services or functions that customarily take place at the direction of the educational institution/agency or their teacher/employee, for which the institutions or agency would otherwise use its own employees, and that aid in the administration or improvement of educational and school activities.” (emphasis added).
This limitation in the Pledge essentially sinks EFF’s complaint. A major part of EFF’s gripe is that when the students interact with non-Education services, Google tracks them. However, the Pledge limits the collection of information only in contexts where “the institutions or agency would otherwise use its own employees” — a definition that clearly does not extend to general Internet usage. This definition would reasonably cover activities like administering classes, tests, and lessons. This definition would not cover activity such as general searches, watching videos on YouTube and the like. Key to EFF’s error is that the pledge is not operative on accounts but around activity — in particular educational activity “for which the institutions or agency would otherwise use its own employees.”
To interpret Google’s activity in the way that EFF does is to treat the Pledge as a promise never to do anything, ever, with the data of a student logged into an education account, whether generated as part of Education apps or otherwise. That just can’t be right. Thinking through the implications of EFF’s complaint, the ultimate end has to be that Google needs to obtain a permission slip from parents before offering access to Google for Education accounts. Administrators and Google are just not allowed to provision any services otherwise.
And here is where the long game comes in. EFF and its peers induced Google to sign the Pledge all the while understanding that their interpretation would necessarily require a re-write of Google’s business model. But not only is this sneaky, it’s also ridiculous. By way of analogy, this would be similar to allowing parents an individual say over what textbooks or other curricular materials their children are allowed to access. This would either allow for a total veto by a single parent, or else would require certain students to be frozen out of participating in homework and other activities being performed with a Google for Education app. That may work for Yale students hiding from microaggressions, but it makes no sense to read such a contentious and questionable educational model into Google’s widely-offered apps.
I think a more reasonable interpretation should prevail. The privacy pledge is meant to govern the use of student data while that student is acting as a student — which in the case of Google for Education apps would mean while using said apps. Plenty of other Google apps could be used for educational purposes, but Google is intentionally delineating a sensible dividing line in order to avoid exactly this sort of problem (as well as problems that could arise under other laws directed at student activity, like COPPA, most notably). It is entirely unreasonable to presume that Google, by virtue of its socially desirable behavior of enabling students to have ready access to technology, is thereby prevented from tracking individuals’ behavior on non-Education apps as it chooses to define them.
What is the Harm?
According to EFF, there are two primary problems with Google’s gathering and use of student data: gathering and using individual data in non-Education apps, and gathering and using anonymized and aggregated data in the Education apps. So what is the evil end to which Google uses this non-Education gathered data?
“Google not only collects and stores the vast array of student data described above, but uses it for its own purposes such as improving Google products and serving targeted advertising (within non-Education Google services)”
The horrors! Google wants to use student behavior to improve its services! And yes, I get it, everyone hates ads — I hate ads too — but at some point you need to learn to accept that the wealth of nominally free apps available to every user is underwritten by the ad-sphere. So if Google is using the non-Education behavior of students to gain valuable insights that it can monetize and thereby subsidize its services, so what? This is life in the twenty-first century, and until everyone collectively decides that we prefer to pay for services up front, we had better get used to being tracked and monetized by advertisers.
But as noted above, whether you think Google should or shouldn’t be gathering this data, it seems clear that the data generated from use of non-Education apps doesn’t fall under the Pledge’s purview. Thus, perhaps sensing the problems in its non-Education use argument, EFF also half-heartedly attempts to demonize certain data practices that Google employs in the Education context. In short, Google aggregates and anonymizes the usage data of the Google for Education apps, and, according to EFF, this is a violation of the Pledge:
“Aggregating and anonymizing students’ browsing history does not change the intensely private nature of the data … such that Google should be free to use it[.]”
Again the “harm” is that Google actually wants to improve the Educational apps: “Google has acknowledged that it collects, maintains, and uses student information via Chrome Sync (in aggregated and anonymized form) for the purpose of improving Google products”
This of course doesn’t violate the Pledge. After all, signatories to the Pledge promise only that they will “[n]ot collect, maintain, use or share student personal information beyond that needed for authorized educational/school purposes.” It’s eminently reasonable to include the improvement of the provisioned services as part of an “authorized educational … purpose[.]” And by ensuring that the data is anonymized and aggregated, Google is clearly acknowledging that some limits are appropriate in the education context — that it doesn’t need to collect individual and identifiable personal information for education purposes — but that improving its education products the same way it improves all its products is an educational purpose.
How are the harms enhanced by Chrome Sync? Honestly, it’s not really clear from EFF’s complaint. I believe that the core of EFF’s gripe (at least here) has to do with how the two data gathering activities may be correlated together. Google has ChromeSync enabled by default, so when the students sign on at different locations, the Education apps usage is recorded and grouped (still anonymously) for service improvement alongside non-Education use. And the presence of these two data sets being generated side-by-side creates the potential to track students in the educational capacity by correlating with information generated in their non-educational capacity.
Maybe there are potential flaws in the manner in which the data is anonymized. Obviously EFF thinks anonymized data won’t stay anonymized. That is a contentious view, to say the least, but regardless, it is in no way compelled by the Pledge. But more to the point, merely having both data sets does not do anything that clearly violates the Pledge.
The End Game
So what do groups like EFF actually want? It’s important to consider the effects on social welfare that this approach to privacy takes, and its context. First, the Pledge was overwhelmingly designed for and signed by pure education companies, and not large organizations like Google, Apple, or Microsoft — thus the nature of the Pledge itself is more or less ill-fitted to a multi-faceted business model. If we follow the logical conclusions of this complaint, a company like Google would face an undesirable choice: On the one hand, it can provide hardware to schools at zero cost or heavily subsidized prices, and also provide a suite of useful educational applications. However, as part of this socially desirable donation, it must also place a virtual invisibility shield around students once they’ve signed into their accounts. From that point on, regardless of what service they use — even non-educational ones — Google is prevented from using any data students generate. At this point, one has to question Google’s incentive to remove huge swaths of the population from its ability to gather data. If Google did nothing but provide the hardware, it could simply leave its free services online as-is, and let schools adopt or not adopt them as they wish (subject of course to extant legislation such as COPPA) — thereby allowing itself to possibly collect even more data on the same students.
On the other hand, if not Google, then surely many other companies would think twice before wading into this quagmire, or, when they do, they might offer severely limited services. For instance, one way of complying with EFF’s view of how the Pledge works would be to shut off access to all non-Education services. So, students logged into an education account could only access the word processing and email services, but would be prevented from accessing YouTube, web search and other services — and consequently suffer from a limitation of potentially novel educational options.
EFF goes on to cite numerous FTC enforcement actions and settlements from recent years. But all of the cited examples have one thing in common that the current complaint does not: they all are violations of § 5 for explicit statements or representations made by a company to consumers. EFF’s complaint, on the other hand, is based on a particular interpretation of an ambiguous document generally drafted, and outside of the the complicated business practice at issue. What counts as “student information” when a user employs a general purpose machine for both educational purposes and non-educational purposes? The Pledge — at least the sections that EFF relies upon in its complaint — is far from clear and doesn’t cover Google’s behavior in an obvious manner.
Of course, the whole complaint presumes that the nature of Google’s services was somehow unfair or deceptive to parents — thus implying that there was at least some material reliance on the Pledge in parental decision making. However, this misses a crucial detail: it is the school administrators who contract with Google for the Chromebooks and Google for Education services, and not the parents or the students. Then again, maybe EFF doesn’t care and it is, as I suggest above, just interested in a long game whereby it can shoehorn Google’s services into some new sort of privacy regime. This isn’t all that unusual, as we have seen even the White House in other contexts willing to rewrite business practices wholly apart from the realities of privacy “harms.”
But in the end, this approach to privacy is just a very efficient way to discover the lowest common denominator in charity. If it even decides to brave the possible privacy suits, Google and other similarly situated companies will provide the barest access to the most limited services in order to avoid extensive liability from ambiguous pledges. And, perhaps even worse for overall social welfare, using the law to force compliance with voluntarily enacted, ambiguous codes of conduct is a sure-fire way to make sure that there are fewer and more limited codes of conduct in the future.
Thanks to the Truth on the Market bloggers for having me. I’m a long-time fan of the blog, and excited to be contributing.
The Third Circuit will soon review the appeal of generic drug manufacturer, Mylan Pharmaceuticals, in the latest case involving “product hopping” in the pharmaceutical industry — Mylan Pharmaceuticals v. Warner Chilcott.
Product hopping occurs when brand pharmaceutical companies shift their marketing efforts from an older version of a drug to a new, substitute drug in order to stave off competition from cheaper generics. This business strategy is the predictable business response to the incentives created by the arduous FDA approval process, patent law, and state automatic substitution laws. It costs brand companies an average of $2.6 billion to bring a new drug to market, but only 20 percent of marketed brand drugs ever earn enough to recoup these costs. Moreover, once their patent exclusivity period is over, brand companies face the likely loss of 80-90 percent of their sales to generic versions of the drug under state substitution laws that allow or require pharmacists to automatically substitute a generic-equivalent drug when a patient presents a prescription for a brand drug. Because generics are automatically substituted for brand prescriptions, generic companies typically spend very little on advertising, instead choosing to free ride on the marketing efforts of brand companies. Rather than hand over a large chunk of their sales to generic competitors, brand companies often decide to shift their marketing efforts from an existing drug to a new drug with no generic substitutes.
Generic company Mylan is appealing U.S. District Judge Paul S. Diamond’s April decision to grant defendant and brand company Warner Chilcott’s summary judgment motion. Mylan and other generic manufacturers contend that Defendants engaged in a strategy to impede generic competition for branded Doryx (an acne medication) by executing several product redesigns and ceasing promotion of prior formulations. Although the plaintiffs generally changed their products to keep up with the brand-drug redesigns, they contend that these redesigns were intended to circumvent automatic substitution laws, at least for the periods of time before the generic companies could introduce a substitute to new brand drug formulations. The plaintiffs argue that product redesigns that prevent generic manufacturers from benefitting from automatic substitution laws violate Section 2 of the Sherman Act.
Product redesign is not per se anticompetitive. Retiring an older branded version of a drug does not block generics from competing; they are still able to launch and market their own products. Product redesign only makes competition tougher because generics can no longer free ride on automatic substitution laws; instead they must either engage in their own marketing efforts or redesign their product to match the brand drug’s changes. Moreover, product redesign does not affect a primary source of generics’ customers—beneficiaries that are channeled to cheaper generic drugs by drug plans and pharmacy benefit managers.
The Supreme Court has repeatedly concluded that “the antitrust laws…were enacted for the protection of competition not competitors” and that even monopolists have no duty to help a competitor. The district court in Mylan generally agreed with this reasoning, concluding that the brand company Defendants did not exclude Mylan and other generics from competition: “Throughout this period, doctors remained free to prescribe generic Doryx; pharmacists remained free to substitute generics when medically appropriate; and patients remained free to ask their doctors and pharmacists for generic versions of the drug.” Instead, the court argued that Mylan was a “victim of its own business strategy”—a strategy that relied on free-riding off brand companies’ marketing efforts rather than spending any of their own money on marketing. The court reasoned that automatic substitution laws provide a regulatory “bonus” and denying Mylan the opportunity to take advantage of that bonus is not anticompetitive.
Product redesign should only give rise to anticompetitive claims if combined with some other wrongful conduct, or if the new product is clearly a “sham” innovation. Indeed, Senior Judge Douglas Ginsburg and then-FTC Commissioner Joshua D. Wright recently came out against imposing competition law sanctions on product redesigns that are not sham innovations. If lawmakers are concerned that product redesigns will reduce generic usage and the cost savings they create, they could follow the lead of several states that have broadened automatic substitution laws to allow the substitution of generics that are therapeutically-equivalent but not identical in other ways, such as dosage form or drug strength.
Mylan is now asking the Third Circuit to reexamine the case. If the Third Circuit reverses the lower courts decision, it would imply that brand drug companies have a duty to continue selling superseded drugs in order to allow generic competitors to take advantage of automatic substitution laws. If the Third Circuit upholds the district court’s ruling on summary judgment, it will likely create a circuit split between the Second and Third Circuits. In July 2015, the Second Circuit court upheld an injunction in NY v. Actavis that required a brand company to continue manufacturing and selling an obsolete drug until after generic competitors had an opportunity to launch their generic versions and capture a significant portion of the market through automatic substitution laws. I’ve previously written about the duty created in this case.
Regardless of whether the Third Circuit’s decision causes a split, the Supreme Court should take up the issue of product redesign in pharmaceuticals to provide guidance to brand manufacturers that currently operate in a world of uncertainty and under the constant threat of litigation for decisions they make when introducing new products.
Ms. Garza is clearly correct. Both the U.S. Justice Department (DOJ) and the U.S. Federal Trade Commission (FTC) enforce the federal antitrust merger review provision, Section 7 of the Clayton Act, and employ a common set of substantive guidelines (last revised in 2010) to evaluate merger proposals. Neutral “rule of law” principles indicate that private parties should expect to have their proposed mergers subject to the same methods of assessment and an identical standard of judicial review, regardless of which agency reviews a particular transaction. (The two agencies decide by mutual agreement which agency will review any given merger proposal.)
Unfortunately, however, that is not the case today. The FTC’s independent ability to challenge mergers administratively, combined with the difference in statutory injunctive standards that apply to FTC and DOJ merger reviews, mean that a particular merger application may face more formidable hurdles if reviewed by the FTC, rather than DOJ. These two differences commendably would be eliminated by the SMARTER Act, which would subject the FTC to current DOJ standards. The SMARTER Act would not deal with a third difference – the fact that DOJ merger consent decrees, but not FTC merger consent decrees, must be filed with a federal court for “public interest” review. This commentary briefly addresses those three issues. The first and second ones present significant “rule of law” problems, in that they involve differences in statutory language applied to the same conduct. The third issue, the question of judicial review of settlements, is of a different nature, but nevertheless raises substantial policy concerns.
FTC Administrative Authority
The first rule of law problem stems from the broader statutory authority the FTC possesses to challenge mergers. In merger cases, while DOJ typically consolidates actions for a preliminary and permanent injunction in district court, the FTC merely seeks a preliminary injunction (which is easier to obtain than a permanent injunction) and “holds in its back pocket” the ability to challenge a merger in an FTC administrative proceeding – a power DOJ does not possess. In short, the FTC subjects proposed mergers to a different and more onerous method of assessment than DOJ. In Ms. Garza’s words (footnotes deleted):
“Despite the FTC’s legal ability to seek permanent relief from the district court, it prefers to seek a preliminary injunction only, to preserve the status quo while it proceeds with its administrative litigation.
This approach has great strategic significance. First, the standard for obtaining a preliminary injunction in government merger challenges is lower than the standard for obtaining a permanent injunction. That is, it is easier to get a preliminary injunction.
Second, as a practical matter, the grant of a preliminary injunction is typically sufficient to end the matter. In nearly every case, the parties will abandon their transaction rather than incur the heavy cost and uncertainty of trying to hold the merger together through further proceedings—which is why merging parties typically seek to consolidate proceedings for preliminary and permanent relief under Rule 65(a)(2). Time is of the essence. As one witness testified before the [Antitrust Modernization Commission], “it is a rare seller whose business can withstand the destabilizing effect of a year or more of uncertainty” after the issuance of a preliminary injunction.
Third, even if the court denies the FTC its preliminary injunction and the parties close their merger, the FTC can still continue to pursue an administrative challenge with an eye to undoing or restructuring the transaction. This is the “heads I win, tails you lose” aspect of the situation today. It is very difficult for the parties to get to the point of a full hearing in court given the effect of time on transactions, even with the FTC’s expedited administrative procedures adopted in about 2008. . . .
[Moreover,] [while] [u]nder its new procedures, parties can move to dismiss an administrative proceeding if the FTC has lost a motion for preliminary injunction and the FTC will consider whether to proceed on a case-by-case basis[,] . . . th[is] [FTC] policy could just as easily change again, unless Congress speaks.”
Typically time is of the essence in proposed mergers, so substantial delays occasioned by extended reviews of those transactions may prevent many transactions from being consummated, even if they eventually would have passed antitrust muster. Ms. Garza’s testimony, plus testimony by former Assistant Deputy Assistant Attorney General for Antitrust Abbott (Tad) Lipsky, document cases of substantial delay in FTC administrative reviews of merger proposals. (As Mr. Lipsky explained, “[a]ntitrust practitioners have long perceived that the possibility of continued administrative litigation by the FTC following a court decision constitutes a significant disincentive for parties to invest resources in transaction planning and execution.”) Congress should weigh these delay-specific costs, as well as the direct costs of any additional burdens occasioned by FTC administrative procedures, in deciding whether to require the FTC (like DOJ) to rely solely on federal court proceedings.
Differences Between FTC and DOJ Injunctive Standards
The second rule of law problem arises from the lighter burden the FTC must satisfy to obtain injunctive relief in federal court. Under Section 13(b) of the FTC Act, an injunction shall be granted the FTC “[u]pon a proper showing that, weighing the equities and considering the Commission’s likelihood of success, such action would be in the public interest.” The D.C. Circuit (in FTC v. H.J. Heinz Co. and in FTC v. Whole Foods Market, Inc.) has stated that, to meet this burden, the FTC need merely have raised questions “so serious, substantial, difficult and doubtful as to make them fair ground for further investigation.” By contrast, as Ms. Garza’s testimony points out, “under Section 15 of the Clayton Act, courts generally apply a traditional equities test requiring DOJ to show a reasonable likelihood of success on the merits—not merely that there is ‘fair ground for further investigation.’” In a similar vein, Mr. Lipsky’s testimony stated that “[t]he cumulative effect of several recent contested merger decisions has been to allow the FTC to argue that it needn’t show likelihood of success in order to win a preliminary injunction; specifically these decisions suggest that the Commission need only show ‘serious, substantial, difficult and doubtful’ questions regarding the merits.” Although some commentators have contended that, in reality, the two standards generally will be interpreted in a similar fashion (“whatever theoretical difference might exist between the FTC and DOJ standards has no practical significance”), there is no doubt that the language of the two standards is different – and basic principles of statutory construction indicate that differences in statutory language should be given meaning and not ignored. Accordingly, merging parties face the real prospect that they might fare worse under federal court review of an FTC challenge to their merger proposal than they would have fared had DOJ challenged the same transaction. Such an outcome, even if it is rare, would be at odds with neutral application of the rule of law.
The Tunney Act
Finally, helpful as it is, the SMARTER Act does not entirely eliminate the disparate treatment of proposed mergers by DOJ and the FTC. The Tunney Act, 15 U.S.C. § 16, enacted in 1974, which applies to DOJ but not to the FTC, requires that DOJ submit all proposed consent judgments under the antitrust laws (including Section 7 of the Clayton Act) to a federal district court for 60 days of public comment prior to being entered.
a. Economic Costs (and Potential Benefits) of the Tunney Act
“[W]hile Tunney Act proceedings are pending, a merged company may have to consider how its post-close actions and integration could be perceived by the court, and may feel the need to compete somewhat less aggressively, lest its more muscular competitive actions be taken by the court, amici, or the public at large to be the actions of a merged company exercising enhanced market power. Such a distortion in conduct probably was not contemplated by the Tunney Act’s drafters, but merger partners will need to be cognizant of how their post-close actions may be perceived during Tunney Act review. . . . [And, in addition,] while Tunney Act proceedings are pending, a merged company may have to consider how its post-close actions and integration could be perceived by the court, and may feel the need to compete somewhat less aggressively, lest its more muscular competitive actions be taken by the court, amici, or the public at large to be the actions of a merged company exercising enhanced market power.”
“Properly interpreted and applied, the Tunney Act serves a number of related, useful functions. The disclosure provisions and judicial approval requirement for decrees can help identify, and more importantly deter, “influence peddling” and other abuses. The notice-and-comment procedures force the DOJ to explain its rationale for the settlement and provide its answers to objections, thus providing transparency. They also provide a mechanism for third-party input, and, thus, a way to identify and correct potentially unnoticed problems in a decree. Finally, the court’s public interest review not only helps ensure that the decree benefits the public, it also allows the court to protect itself against ambiguous provisions and enforcement problems and against an objectionable or pointless employment of judicial power. Improperly applied, the Tunney Act does more harm than good. When a district court takes it upon itself to investigate allegations not contained in a complaint, or attempts to “re-settle” a case to provide what it views as stronger, better relief, or permits lengthy, unfocused proceedings, the Act is turned from a useful check to an unpredictable, costly burden.”
The justifications presented by the author are open to serious question. Whether “influence peddling” can be detected merely from the filing of proposed decree terms is doubtful – corrupt deals to settle a matter presumably would be done “behind the scenes” in a manner not available to public scrutiny. The economic expertise and detailed factual knowledge that informs a DOJ merger settlement cannot be fully absorbed by a judge (who may fall prey to his or her personal predilections as to what constitutes good policy) during a brief review period. “Transparency” that facilitates “third-party input” can too easily be manipulated by rent-seeking competitors who will “trump up” justifications for blocking an efficient merger. Moreover, third parties who are opposed to mergers in general may also be expected to file objections to efficient arrangements. In short, the “sunshine” justification for Tunney Act filings is more likely to cloud the evaluation of DOJ policy calls than to provide clarity.
b. Constitutional Issues Raised by the Tunney Act
In addition to potential economic inefficiencies, the judicial review feature of the Tunney Act raises serious separation of powers issues, as emphasized by the DOJ Office of Legal Counsel (OLC, which advises the Attorney General and the President on questions of constitutional interpretation) in a 1989 opinion regarding qui tam provisions of the False Claims Act:
“There are very serious doubts as to the constitutionality . . . of the Tunney Act: it intrudes into the Executive power and requires the courts to decide upon the public interest – that is, to exercise a policy discretion normally reserved to the political branches. Three Justices of the Supreme Court questioned the constitutionality of the Tunney Act in Maryland v. United States, 460 U.S. 1001 (1983) (Rehnquist, J., joined by Burger, C.J., and White, J., dissenting).”
Notably, this DOJ critique of the Tunney Act was written before the 2004 amendments to that statute that specifically empower courts to consider the impact of proposed settlements “upon competition and upon the public generally” – language that significantly trenches upon Executive Branch prerogatives. Admittedly, the Tunney Act has withstood judicial scrutiny – no court has ruled it unconstitutional. Moreover, a federal judge can only accept or reject a Tunney Act settlement, not rewrite it, somewhat ameliorating its affront to the separation of powers. In short, even though it may not be subject to serious constitutional challenge in the courts, the Tunney Act is problematic as a matter of sound constitutional policy.
c. Congressional Reexamination of the Tunney Act
These economic and constitutional policy concerns suggest that Congress may wish to carefully reexamine the merits of the Tunney Act. Any such reexamination, however, should be independent of, and not delay expedited consideration of, the SMARTER Act. The Tunney Act, although of undoubted significance, is only a tangential aspect of the divergent legal standards that apply to FTC and DOJ merger reviews. It is beyond the scope of current legislative proposals but it merits being taken up at an appropriate time – perhaps in the next Congress. When Congress turns to the Tunney Act, it may wish to consider four options: (1) repealing the Act in its entirety; (2) retaining the Act as is; (3) partially repealing it only with respect to merger reviews; or, (4) applying it in full force to the FTC. A detailed evaluation of those options is beyond the scope of this commentary.
In sum, in order to eliminate inconsistencies between FTC and DOJ standards for reviewing proposed mergers, Congress should give serious consideration to enacting the SMARTER Act, which would both eliminate FTC administrative review of merger proposals and subject the FTC to the same injunctive standard as the DOJ in judicial review of those proposals. Moreover, if the SMARTER Act is enacted, Congress should also consider going further and amending the Tunney Act to make it apply to FTC as well as to DOJ merger settlements – or, alternatively, to have it not apply at all to any merger settlements (a result which would better respect the constitutional separation of powers and reduce a potential source of economic inefficiency).
But are the leaders at the U.S. Department of Justice Antitrust Division (DOJ) and the Federal Trade paying any attention? The most recent public reports are not encouraging.
In a very recent filing with the U.S. International Trade Commission (ITC), FTC Chairwoman Edith Ramirez stated that “the danger that bargaining conducted in the shadow of an [ITC] exclusion order will lead to patent hold-up is real.” (Comparable to injunctions, ITC exclusion orders preclude the importation of items that infringe U.S. patents. They are the only effective remedy the ITC can give for patent infringement, since the ITC cannot assess damages or royalties.) She thus argued that, before issuing an exclusion order, the ITC should require an SEP holder to show that the infringer is unwilling or unable to enter into a patent license on “fair, reasonable, and non-discriminatory” (FRAND) terms – a new and major burden on the vindication of patent rights. In justifying this burden, Chairwoman Ramirez pointed to Motorola’s allegedly excessive SEP royalty demands from Microsoft – $6-$8 per gaming console, as opposed to a federal district court finding that pennies per console was the appropriate amount. She also cited LSI Semiconductor’s demand for royalties that exceeded the selling price of Realtek’s standard-compliant product, whereas a federal district court found the appropriate royalty to be only .19% of the product’s selling price. But these two examples do not support Chairwoman Ramirez’s point – quite the contrary. The fact that high initial royalty requests subsequently are slashed by patent courts shows that the patent litigation system is working, not that antitrust enforcement is needed, or that a special burden of proof must be placed on SEP holders. Moreover, differences in bargaining positions are to be expected as part of the normal back-and-forth of bargaining. Indeed, if anything, the extremely modest judicial royalty assessments in these cases raise the concern that SEP holders are being undercompensated, not overcompensated.
A recent speech by DOJ Assistant Attorney General for Antitrust (AAG) William J. Baer, delivered at the International Bar Association’s Competition Conference, suffers from the same sort of misunderstanding as Chairman Ramirez’s ITC filing. Stating that “[h]old up concerns are real”, AAG Baer cited the two examples described by Chairwoman Ramirez. He also mentioned the fact that Innovatio requested a royalty rate of over $16 per smart tablet for its SEP portfolio, but was awarded a rate of less than 10 cents per unit by the court. While admitting that the implementers “proved victorious in court” in those cases, he asserted that “not every implementer has the wherewithal to litigate”, that “[s]ometimes implementers accede to licensors’ demands, fearing exclusion and costly litigation”, that “consumers can be harmed and innovation incentives are distorted”, and that therefore “[a] future of exciting new products built atop existing technology may be . . . deferred”. These theoretical concerns are belied by the lack of empirical support for hold-up, and are contradicted by the recent finding, previously noted, that SEP-reliant industries have the fastest quality-adjusted price declines in the U.S. economy. (In addition, the implementers of patented technology tend to be large corporations; AAG Baer’s assertion that some may not have “the wherewithal to litigate” is a bare proposition unsupported by empirical evidence or more nuanced analysis.) In short, DOJ, like FTC, is advancing an argument that undermines, rather than bolsters, the case for applying antitrust to SEP holders’ efforts to defend their patent rights.
Ideally the FTC and DOJ should reevaluate their recent obsession with allegedly abusive unilateral SEP behavior and refocus their attention on truly serious competitive problems. (Chairwoman Ramirez and AAG Baer are both outstanding and highly experienced lawyers who are well-versed in policy analysis; one would hope that they would be open to reconsidering current FTC and DOJ policy toward SEPs, in light of hard evidence.) Doing so would benefit consumer welfare and innovation – which are, after all, the goals that those important agencies are committed to promote.