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

TOTM 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, . . .

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.

Read the full piece here.

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Innovation & the New Economy

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

TOTM 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 . . .

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.

Read the full piece here.

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Innovation & the New Economy

Net Neutrality and Broken Records

TOTM Idon’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 . . .

Idon’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 Sept. 28, the FCC published a “fact sheet” and a notice of proposed rulemaking (NPRM) on “Safeguarding and Securing the Open Internet.” Just shy of a month later, on Oct. 25, the FCC published another “fact sheet” and NPRM—this one, on “Preventing Digital Discrimination.”

My International Center for Law & Economics (ICLE) colleague Eric Fruits has written about the proposals hereherehereherehere, and, with our colleague Ben Sperry, here. ICLE’s Kristian Stout is hereEric explains how, in relatively straightforward fashion, the anti-discrimination requirements could lead to price regulation, notwithstanding the FCC’s own observation that “there is little to no evidence of intentional digital discrimination of access.”

Read the full piece here.

 

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Telecommunications & Regulated Utilities

I, For One, Welcome Our New FTC Overlords

TOTM In this post—the last planned post for this symposium on The FTC’s New Normal (though we will continue to accept unsolicited submissions of responses)—I will offer some . . .

In this post—the last planned post for this symposium on The FTC’s New Normal (though we will continue to accept unsolicited submissions of responses)—I will offer some summary of the ideas that have been shared here over the past month, before turning to some of my own thoughts. To keep your attention rapt, I will preview that my thoughts will live up to the title of this post: I will sing some sincere praise for the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) honesty and newfound litigiousness.

Read the full piece here.

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Antitrust & Consumer Protection

Chevron and Administrative Antitrust, Redux

Scholarship Abstract In 2014, I published a pair of articles—Administrative Antitrust and Chevron and the Limits of Administrative Antitrust—that argued that the Supreme Court’s recent antitrust . . .

Abstract

In 2014, I published a pair of articles—Administrative Antitrust and Chevron and the Limits of Administrative
Antitrust—that argued that the Supreme Court’s recent antitrust and administrative law jurisprudence was pushing antitrust law out of the judicial domain and into the domain of regulatory agencies. The first article focused on the Court’s then-recent antitrust cases and argued that the Court, which had abrogated most areas of federal common law, had shown a clear preference for handling common law-like antitrust law on a statutory or regulatory basis where possible. The second article evaluated and rejected the Federal Trade Commission’s (“FTC’s”) long-held belief that its interpretations of the FTC Act do not receive Chevron deference. This Article will revisit those articles in light of the past decade of Supreme Court precedent. In reviewing those articles, this Article will argue that, for the same reasons that the Court seemed likely in 2013 to embrace an administrative approach to antitrust, today it is likely to view such approaches with great skepticism unless they are undertaken on a cautious and incrementalistic basis. That is, the Court will embrace an administrative approach to antitrust where it will prove less indeterminate than judicially defined antitrust law. If the FTC approaches antitrust law aggressively, decreasing the predictability of the law, the Court seems likely to close the door on administrative antitrust for reasons sounding in both administrative and antitrust law. This conclusion differs from other current work examining the Commission’s authority—such as on major questions grounds or whether the Commission has substantive “unfair methods of competition” rulemaking authority—in that it is primarily based on the Court’s views on the relationship of antitrust and administrative law.

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Antitrust & Consumer Protection

Net Neutrality II: Electric Boogaloo—Rate Regulation Hiding in Plain Sight

TOTM Federal Communications Commission (FCC) Chair Jessica Rosenworcel on Tuesday announced the agency’s proposal to regulate internet services under Title II of the Communications Act. Commonly referred . . .

Federal Communications Commission (FCC) Chair Jessica Rosenworcel on Tuesday announced the agency’s proposal to regulate internet services under Title II of the Communications Act. Commonly referred to as “net neutrality,” the chair plans to release proposed rules today, with a vote scheduled for Oct. 19 to begin the rulemaking process.

Read the full piece here.

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Telecommunications & Regulated Utilities

Radical New Burdens for Marginal Benefit

Scholarship Abstract The Global Antitrust Institute (“GAI”) provided comments to the U.S. Federal Trade Commission (“FTC”) in response to the FTC’s proposal to make significant amendments . . .

Abstract

The Global Antitrust Institute (“GAI”) provided comments to the U.S. Federal Trade Commission (“FTC”) in response to the FTC’s proposal to make significant amendments to the rules governing premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act. The proposal will, if implemented, substantially increase burdens on all merging parties, regardless of whether the transaction reported poses an anticompetitive risk. In Section I we review the market for corporate control and the benefits it can have for effective firm management, allocative efficiency of economic resources, and consumer welfare. In Section II we explain how, contrary to the FTC’s view, the proposed changes will significantly increase the burden imposed on filing parties. This will impede the market for corporate control and consequently reduce productivity and inhibit innovation in other markets. In Section III we highlight potential conflicts between the proposed rule amendments and the Administrative Procedures Act.

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Antitrust & Consumer Protection

Recent Antitrust and Regulatory Changes Both Unravel the Consensus

TOTM Presidential administrations over the last 50 years have pursued widely varying policy goals, but they have agreed—at least, in principle—that policies should be efficient and . . .

Presidential administrations over the last 50 years have pursued widely varying policy goals, but they have agreed—at least, in principle—that policies should be efficient and improve social welfare. Now, the Biden administration is taking steps to unravel that bipartisan consensus. We focus on different policy areas (Dudley on regulation and Sullivan on antitrust) and are struck by the similarities among the radical changes being proposed.

Read the full piece here.

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Antitrust & Consumer Protection

The FTC Tacks Into the Gale, Battening No Hatches: Part 1

TOTM The Evolution of FTC Antitrust Enforcement – Highlights of Its Origins and Major Trends 1910-1914 – Creation and Launch The election of 1912, which led . . .

The Evolution of FTC Antitrust Enforcement – Highlights of Its Origins and Major Trends

1910-1914 – Creation and Launch

The election of 1912, which led to the creation of the Federal Trade Commission (FTC), occurred at the apex of the Progressive Era. Since antebellum times, Grover Cleveland had been the only Democrat elected as president. But a Democratic landslide in the 1910 midterms during the Taft administration substantially reduced the Republicans’ Senate majority and gave the Democrats a huge majority in the House, signaling a major political shift. Spurred by progressive concern that Standard Oil—decided in 1911—signaled judicial leniency toward trusts and monopolies, government control of big business became the leading issue of the 1912 campaign. Both the progressive Democrats and the so-called Republican “insurgents” favored stronger antitrust laws, reduced hours and an antitrust exemption for workers, and closer federal regulation of banking and currency, among other items. Progressive agendas led both Woodrow Wilson’s “New Freedom” platform and the “New Nationalism” of former Republican President Theodore Roosevelt and his Bull Moose Party.

Read the full piece here.

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Antitrust & Consumer Protection