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Showing archive for:  “Pharmaceutical Industry”

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 Two

The Federal Trade Commission (FTC) recently announced that it would sue to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics. The challenge represents a landmark in the history of pharmaceutical-industry antitrust enforcement, as the industry has largely been given license to engage in permissive mergers and acquisitions of smaller companies without challenge. In Part ... FTC v Amgen: The Economics of Bundled Discounts, Part Two

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

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

The FTC UMC Roundup–A Weekly Review

Welcome to the FTC UMC Roundup, our new weekly update of news and events relating to antitrust and, more specifically, to the Federal Trade Commission’s (FTC) newfound interest in “revitalizing” the field. Each week we will bring you a brief recap of the week that was and a preview of the week to come. All ... The FTC UMC Roundup–A Weekly Review

Can the FTC Use Rulemaking to Change Antitrust Law?

FTC Rulemaking Power In 2021, President Joe Biden appointed a prolific young scholar, Lina Khan, to chair the Federal Trade Commission (FTC). Khan strongly dislikes almost every element of antitrust law. She has stated her intention to use notice and comment rulemaking to change antitrust law in many ways. She was unable to begin this process ... Can the FTC Use Rulemaking to Change Antitrust Law?