Showing archive for: “Pharmaceutical Industry”
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
FTC v. Illumina/Grail – A Rare FTC Merger Victory? (Actually, a Loss for Consumers)
Although it was overshadowed by the Federal Trade Commission (FTC) and U.S. Justice Department’s (DOJ) year-end release of the 2023 merger guidelines, one should also note the abrupt end of the FTC v. Illumina/Grail saga. The saga finished with the FTC’s Dec. 18 press release announcing that Illumina decided on Dec.17 to divest itself of ... FTC v. Illumina/Grail – A Rare FTC Merger Victory? (Actually, a Loss for Consumers)
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
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
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
Antitrust at the Agencies Roundup: Take My Default … Please! Edition
I can hardly believe it, but I’ve read that a famous old bit by Henny Youngman has been purged from Florida textbooks, apparently because it was deemed offensive to those who wrote, told, and laughed at the joke. I won’t tell it here, but you can look it up. And if you’re a reader of ... Antitrust at the Agencies Roundup: Take My Default … Please! Edition
FTC v Amgen: The Economics of Bundled Discounts, Part One
The Federal Trade Commission (FTC) recently announced that it would seek to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics. The move was the culmination of several years’ worth of increased scrutiny from both Congress and the FTC into antitrust issues in the biopharmaceutical industry. While the FTC’s move didn’t elicit much public comment, ... FTC v Amgen: The Economics of Bundled Discounts, Part One
Antitrust at the Agencies Roundup: The Orphan’s Hypothetical Competitor Edition
Some may refer to this as the Roundup Formerly Known as the FTC Roundup. If you recorded yourself while reading out loud, and your name is Dove, that is what it sounds like when doves sigh. Maybe He Never Said ‘Never’ The U.S. Justice Department’s (DOJ) Antitrust Division recently agreed to settle its challenge of Swedish conglomerate ... Antitrust at the Agencies Roundup: The Orphan’s Hypothetical Competitor Edition
Biweekly FTC Roundup: Antitrust Woodstock Edition
Last week’s roundup was postponed because I was kibbitzing at the spring meeting of the American Bar Association (ABA) Antitrust Section. For those outside the antitrust world, the spring meeting is the annual antitrust version of Woodstock. For those inside the antitrust world: Antitrust Woodstock is not really a thing. At the planetary-orbit level, the ... Biweekly FTC Roundup: Antitrust Woodstock Edition
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
Biweekly FTC Roundup: Grail-Shaped Beacon Edition
The lame duck is not yet dead, and the Federal Trade Commission (FTC) is supposed to be an independent agency. Work continues. The Commission has announced a partly open oral argument in the Illumina-Grail matter. That is, parts of the argument will be open to the public, via webcast, and parts won’t. This is what’s ... Biweekly FTC Roundup: Grail-Shaped Beacon Edition
