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A Pandemic Treaty Will Double Down on All the Bad Ideas from COVID-19

Popular Media When 194 countries meet in May for the annual World Health Assembly, the World Health Organization (WHO) intends to push health ministers to sign a . . .

When 194 countries meet in May for the annual World Health Assembly, the World Health Organization (WHO) intends to push health ministers to sign a pandemic treaty. Granting the WHO this power risks spurring a new pandemic.

The WHO got a lot of policies wrong on COVID, many of which would effectively be codified in the new treaty. The agency pushed lockdowns and vaccine and mask mandates and promised vaccines would prevent transmission. It consistently failed to show interest in key issues like COVID’s origin or how Sweden achieved such remarkable outcomes — notably half the U.S. death rate — without these draconian measures. And it foolishly believed China would be transparent with its data and control the virus.

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Innovation & the New Economy

The WHO’s Insufficient Curiosity and Humility

TOTM Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly . . .

Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly agree to amendments to the International Health Regulations (IHRs), which are intended to “prevent, protect against, prepare, control and provide a public health response to the international spread of diseases.” Ministers will also be asked to approve the text of a new World Health Organization (WHO) convention to combat future pandemics.

While there is a need to coordinate the detection of and response to potential pandemics, it is not clear what role, if any, the WHO should have. Perhaps more importantly, it is uncertain what policies should be put in place (and by whom) to prevent, limit, and respond to any future pandemic. The U.S. government should encourage the WHO to delay both changes to the IHRs and the introduction of a new treaty until several issues are satisfactorily resolved.

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Innovation & the New Economy

Three Problems with Accelerated Access: Will They Be Overcome?

TOTM This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain . . .

This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. Yet from a risk perspective, the standards are quite different; by shifting risk taking from regulator to patient, physician, and payer, this creates problems. The second problem is more practical and is generally considered the most significant problem with accelerated approval. Some companies that have received accelerated approval for their products have not done confirmatory studies, as required by their agreement with FDA. This leads to distrust of these companies and their products, and threatens to undermine the accelerated-approval program. The third problem is the issue of approving medicines with marginal benefits.

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Innovation & the New Economy

Oncology Drives Most Recent Accelerated Approvals

TOTM 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 . . .

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 benefits of accelerated approval and how oncology medicines have become the treatment category with the most accelerated approvals.

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Innovation & the New Economy

Hands Across the Agencies

TOTM In the headline to a Dec. 7 press release, the Federal Trade Commission (FTC) announced that it, in concert with the U.S. Justice Department (DOJ) and . . .

In the headline to a Dec. 7 press release, the Federal Trade Commission (FTC) announced that it, in concert with the U.S. Justice Department (DOJ) and U.S. Department of Health and Human Services (HHS), had managed to “Lower Health Care and Drug Costs, Promote Competition to Benefit Patients, Health Care Workers.” According to the subhead: “Recent agency actions have helped lower costs, increase care quality for consumers and promote competition across the health care market.”

The headline sounds great. One wonders about the extent to which the subhead is true.

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Antitrust & Consumer Protection

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.

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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.

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Innovation & the New Economy

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.

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Antitrust & Consumer Protection

Abby Normal, a Flood of Ill-Considered Withdrawals, and the FTC’s Theatre of Listening

TOTM 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 . . .

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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Antitrust & Consumer Protection