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A Consumer-Welfare-Centric Reform Agenda for the Federal Trade Commission

As we approach a presidential election year, it is time to begin developing a  comprehensive reform agenda for the Federal Trade Commission (FTC). In that spirit, this post proposes 12 reforms that could be implemented by new leadership, either through unilateral action by a new chair or (in some cases) majority votes of the commission. ... A Consumer-Welfare-Centric Reform Agenda for the Federal Trade Commission

Oncology Drives Most Recent Accelerated Approvals

In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s efficacy. Allowing HIV patients to take investigational treatments meant that research into rarer conditions—which previously would never have been profitable—might now be financially worthwhile. This post estimates the ... Oncology Drives Most Recent Accelerated Approvals

ICLE Files Amicus in NetChoice Social-Media Regulation Cases

Through our excellent counsel at Yetter Coleman LLP, the International Center for Law & Economics (ICLE ) filed an amicus brief with the U.S. Supreme Court in the Moody v. NetChoice and NetChoice v. Paxton cases. In it, we argue that the First Amendment’s protection of the “marketplace of ideas” requires allowing private actors—like social-media ... ICLE Files Amicus in NetChoice Social-Media Regulation Cases

Where Are the New FTC Rules?

Perhaps more than at any time in its history, the Federal Trade Commission (FTC) under Chair Lina Khan has highlighted substantive rulemaking as a central element of its policy agenda. But despite a great deal of rule-related sound and fury (signifying nothing?), new final rules have yet to emerge, and do not appear imminent. This ... Where Are the New FTC Rules?

A Brief History of the US Drug Approval Process, and the Birth of Accelerated Approval

This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, how disasters drove its expansion and regulatory oversight, and how the epidemic of the human immunodeficiency virus (HIV) changed the approval processes. The Arrival of New Medicines Lone inventors, ... A Brief History of the US Drug Approval Process, and the Birth of Accelerated Approval

Making Sure New Medicines Are Safe, Effective, and Approved Quickly: A Theoretical Approach

This is the first in what will be a series of posts discussing how new medicines are introduced and regulated in the United States, and how the status quo could be improved. As will be established over the course of the series, the current system is slow and leads to poor outcomes for patients.  Why ... Making Sure New Medicines Are Safe, Effective, and Approved Quickly: A Theoretical Approach

EU’s Cybersecurity Draft Shifts Toward Hard Protectionism

A year ago, we cautioned that the EU Cybersecurity Certification Scheme for Cloud Services (EUCS) threatened to embed ill-conceived economic protectionism into the EU’s cybersecurity rules. And, indeed, the European Commission, which has made clear its commitment to pursue “digital sovereignty” for the European Union, can claim some preliminary successes on that front. A recent ... EU’s Cybersecurity Draft Shifts Toward Hard Protectionism

Gatekeeping, the DMA, and the Future of Competition Regulation

The European Commission late last month published the full list of its “gatekeeper” designations under the Digital Markets Act (DMA). Alphabet, Amazon, Apple, ByteDance, Meta, and Microsoft—the six designated gatekeepers—now have six months to comply with the DMA’s list of obligations and restrictions with respect to their core platform services (CPS), or they stand to ... Gatekeeping, the DMA, and the Future of Competition Regulation

The Biden Executive Order on AI: A Recipe for Anticompetitive Overregulation

The Biden administration’s Oct. 30 “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” proposes to “govern… the development and use of AI safely and responsibly” by “advancing a coordinated, Federal Government-wide approach to doing so.” (Emphasis added.) This “all-of-government approach,” which echoes the all-of-government approach of the 2021 “Executive ... The Biden Executive Order on AI: A Recipe for Anticompetitive Overregulation

When Progress Is Regressive: The Ordo-Brandeisian Devolution

It is no coincidence that ordoliberalism—the European (originally German) alternative to classical liberalism that emphasized the importance of the “social market” economy—and the New Brandeis or “neo-Brandeisian” movement, which harkens back to the Progressive Era thought of the late U.S. Supreme Court Justice Louis Brandeis, both are enjoying comebacks simultaneously. The effects of these ideological ... When Progress Is Regressive: The Ordo-Brandeisian Devolution

Biden’s AI Executive Order Sees Dangers Around Every Virtual Corner

Here in New Jersey, where I live, the day before Halloween is commonly celebrated as “Mischief Night,” an evening of adolescent revelry and light vandalism that typically includes hurling copious quantities of eggs and toilet paper. It is perhaps fitting, therefore, that President Joe Biden chose Oct. 30 to sign a sweeping executive order (EO) ... Biden’s AI Executive Order Sees Dangers Around Every Virtual Corner

Market Power as a Limiting Principle in Merger Enforcement

One of the most important changes in the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) draft merger guidelines is the abandonment of market power as the central element of merger enforcement. The “unifying theme” of the 2010 horizontal merger guidelines was that “mergers should not be permitted to create, enhance, or entrench market ... Market Power as a Limiting Principle in Merger Enforcement