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
Indiana Jones and the Allocation of Spectrum
Hootenannies are mostly peaceful affairs, so it’s a bit awkward to invoke a violent metaphor here. In “Raiders of the Lost Ark,” Indiana Jones runs down a Cairo sidestreet only to be confronted by a swordsman. The swordsman makes a big show of tossing his weapon from hand-to-hand and swirling it around. But Indy has ... Indiana Jones and the Allocation of Spectrum
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
An Inconvenient Truth: Net Neutrality Depresses Broadband Investment
It happens at just about every hootenanny. There’s always at least one song that clears the dance floor. Some tunes, people just won’t dance to. But with a little remixing and a better tempo, even a dirge can be danceable. For years, the Federal Communications Commission (FCC) has refused to dance to the tune of ... An Inconvenient Truth: Net Neutrality Depresses Broadband Investment
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
Latin America Should Follow Its Own Path on Digital-Markets Competition
In order to promote competition in digital markets,[1] Latin American countries should not copy and paste “solutions” from other jurisdictions, but rather design their own set of policies. In short, Latin American countries—like my own, Peru—should not “put the cart before the horse” and regulate markets that are not yet mature. Digital or “tech” markets ... Latin America Should Follow Its Own Path on Digital-Markets Competition
Net Neutrality and Broken Records
I don’t mean to sound like a broken record, but why is the Federal Communications Commission (FCC) playing a broken record? I’ve been writing a fair bit about Federal Trade Commission (FTC) rulemaking initiatives. On the theory that you deserve a nominal break from all of that, this post is mostly about the FCC. On ... Net Neutrality and Broken Records
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
Gotta Go Fast: Sonic the Hedgehog Meets the FCC
Federal Communications Commission (FCC) Chair Jessica Rosenworcel this week announced a notice of inquiry (NOI) seeking input on a proposal to raise the minimum connection-speed benchmarks that the commission uses to define “broadband.” The current benchmark speed is 25/3 Mbps. The chair’s proposal would raise the benchmark to 100/20 Mbps, with a goal of having ... Gotta Go Fast: Sonic the Hedgehog Meets the FCC
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
