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.

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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.

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Abstract

Physician non-compete agreements may have significant competitive implications, but they are treated variously under the law on a state-by-state basis. Reviewing the relevant law and the economic literature cannot identify with confidence the net effects of such agreements on either physicians or health care delivery with any generality. In addition to identifying future research projects to inform policy, it is argued that the antitrust “rule of reason” provides a useful framework with which to evaluate such agreements in specific health care markets and, potentially, to address those agreements most likely to do significant damage to health care competition and consumer welfare.

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.

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Lina M. Khan was sworn in as chair of the Federal Trade Commission (FTC) on June 15, 2021. On July 9 of that year, the FTC withdrew the commission’s 2015 “Statement of Enforcement Principles Regarding ‘Unfair Methods of Competition’ Under Section 5 of the FTC Act.” That three-week lag was, in practical terms, nothing. Even ignoring the many practical/ministerial/managerial things that come with assuming the chair, there’s a certain amount of process required of policy decisions at the commission.

As many noted at the time, rescinding the 2015 statement, “absent any new guidance about how the Commission interprets its authority,” did little to signal the commission’s new view of its authority. That is, apart from the vague signal that a far more expansive statement was forthcoming and, of course, a not-so-tepid statement that…

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Back in 2020, an academic paper suggested that over 80% of US physicians mistakenly thought that nicotine was a carcinogen. The implication of this finding was that perhaps physicians considered vaping (and even nicotine replacement therapy) almost as dangerous as smoking. But physicians are busy people, and I wondered if some, maybe most, might have misunderstood the question in the survey and assumed the researchers were asking about smoking.

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In 2020, an academic paper suggested that more than 80% of U.S. physicians mistakenly thought that nicotine was a carcinogen. The implication of this finding was that perhaps physicians thought vaping (and even nicotine-replacement therapy) to be almost as dangerous as smoking. But physicians are busy people and I suggest that some, maybe most, might have misunderstood the question in the survey and assumed the researchers were asking about smoking.

To test this hypothesis, I surveyed physicians to learn more about their actual knowledge and opinion. Additionally, the UK government is more supportive of vaping and other nontraditional nicotine-replacement therapies than U.S. government, so a comparison of UK and U.S. physicians was undertaken to see if government policy and advice affects physician knowledge and opinion.

I find that most physicians correctly recognize that nicotine does not cause cancer, but that far more U.S. physicians than UK physicians still believe that it is carcinogenic. Additionally, vaping is viewed far more positively as a smoking-cessation tool by the surveyed UK physicians than surveyed U.S. physicians, and this is partly caused by the mistaken stance by U.S. health authorities.

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This week the Federal Reserve announced that it expects a recession in the coming months. Companies are already engaging in hiring freezes and layoffs, and several economic indicators point to a pessimistic future. But a pending Department of Labor (DOL) rule could make this recession more severe by cutting off work opportunities for millions of Americans.

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Regrettably, but not unexpectedly, the Federal Trade Commission (FTC) yesterday threw out a reasoned decision by its administrative law judge and ordered DNA-sequencing provider Illumina Inc. to divest GRAIL Inc., makers of a multi-cancer early detection (MCED) test.

Read the full piece here.