The Archives

The collection of all scholarly commentary on law, economics, and more

Showing archive for:  “Health Care”

The FTC Office of Patent Invalidation

The Federal Trade Commission (FTC) announced late last month that it had “expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma, and COPD drugs, including Novo Nordisk Inc.’s blockbuster weight-loss drug, Ozempic.” Warning letters ... The FTC Office of Patent Invalidation

Once More Unto the Breach, Dear Friends: More Regulatory Overreach by the FTC

Go big or go home, they say. It’s not really an either-or choice: one can go big, and then go home. Not infrequently, an attempt to go big is what gets one sent home.  The Federal Trade Commission (FTC) swung for the fences in April 23’s open meeting. On purely partisan lines, the commission voted ... Once More Unto the Breach, Dear Friends: More Regulatory Overreach by the FTC

March-Right-on-In Rights?

The National Institute for Standards and Technology (NIST) published a request for information (RFI) in December 2023 on its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.” It’s quite something, if not in a good way. March-In Rights Provide Very Limited Exceptions to Intellectual-Property Rights What are “march-in” rights? In brief, they ... March-Right-on-In Rights?

The FTC’s Misguided Campaign to Expand Bayh-Dole ‘March-In’ Rights

The Federal Trade Commission (FTC) has now gone on record in comments to the National Institute of Standards and Technology (NIST) that it supports expanded “march-in rights” under the Bayh-Dole Act (Act). But if NIST takes the FTC’s (unexpected, but ultimately unsurprising) contribution seriously, such an expansion could lead to overregulation that would ultimately hurt ... The FTC’s Misguided Campaign to Expand Bayh-Dole ‘March-In’ Rights

The WHO’s Insufficient Curiosity and Humility

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.” ... The WHO’s Insufficient Curiosity and Humility

Three Problems with Accelerated Access: Will They Be Overcome?

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 ... Three Problems with Accelerated Access: Will They Be Overcome?

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

Hands Across the Agencies

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: ... Hands Across the Agencies

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

I, For One, Welcome Our New FTC Overlords

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 ... I, For One, Welcome Our New FTC Overlords

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

What will become of our culture if we forget the classics? Two bits seem salient here, would that either were my own. Dr. Frankenstein: Now, that brain you gave me. Was it Hans Delbruck’s? Igor: … [pause] … No. Dr. Frankenstein: Ah! Very good. Would you mind telling me whose brain I did put in? ... Abby Normal, a Flood of Ill-Considered Withdrawals, and the FTC’s Theatre of Listening