Showing archive for: “Health Care”
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
Health Care and Health Insurance Merger Retrospective: A Personal Law & Economics Experience
My colleagues at the International Center for Law & Economics (ICLE) often engage not only in excellent analysis of proposed mergers and acquisitions, but also have been known to offer retrospectives on past mergers. Today, I want to offer a very personal version of this. A little background: on June 3, 2022, I was diagnosed ... Health Care and Health Insurance Merger Retrospective: A Personal Law & Economics Experience
A Comparison of US and UK Physicians Advice on Nicotine and Vaping
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 ... A Comparison of US and UK Physicians Advice on Nicotine and Vaping
When Bad Antitrust Costs Lives: The Illumina/GRAIL Tragedy
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. The FTC claims that this vertical merger would stifle competition and innovation in the U.S. market for ... When Bad Antitrust Costs Lives: The Illumina/GRAIL Tragedy
FTC Biweekly UMC Roundup – Refugee from the FTC Edition
Faithful and even occasional readers of this roundup might have noticed a certain temporal discontinuity between the last post and this one. The inimitable Gus Hurwitz has passed the scrivener’s pen to me, a recent refugee from the Federal Trade Commission (FTC), and the roundup is back in business. Any errors going forward are mine. ... FTC Biweekly UMC Roundup – Refugee from the FTC Edition
Antitrust Populists Don’t Seem to Care About the Poor
Antitrust populists like Biden White House official Tim Wu and author Matt Stoller decry the political influence of large firms. But instead of advocating for policies that tackle this political influence directly, they seek reforms to antitrust enforcement that aim to limit the economic advantages of these firms, believing that will translate into political enfeeblement. ... Antitrust Populists Don’t Seem to Care About the Poor
