Showing archive for: “Health Care”
Antitrust at the Agencies: The Meat of the Matter Edition
The Federal Trade Commission (FTC) issued comments Sept. 11 in support of a proposed U.S. Department of Agriculture (USDA) rule that “seeks to clarify the scope of what constitutes unfair practices under the Packers and Stockyards Act (PSA), which assures fair competition and fair trade practices to protect farmers, ranchers, growers, and consumers.” In the ... Antitrust at the Agencies: The Meat of the Matter Edition
The FTC Case Against PBM Rebates
About a month ago, the Wall Street Journal reported that the Federal Trade Commission (FTC) was preparing an antitrust suit against the nation’s three largest pharmaceutical benefit managers (PBMs), the intermediaries who negotiate drug prices on behalf of insurers and who manage benefits for nearly nine in 10 insured Americans. This development followed a two-year ... The FTC Case Against PBM Rebates
Reports of the Current FTC’s Intellectual Integrity Have Been Greatly Exaggerated
The Federal Trade Commission (FTC) has released its long-awaited report on pharmacy benefit managers (PBMs) as an “interim staff report.” And it’s yet another staff report that doesn’t name the relevant staff. On the one hand, it does contain some useful information on industry developments. On the other, it’s just not very good—at all. With ... Reports of the Current FTC’s Intellectual Integrity Have Been Greatly Exaggerated
The Waiting Game: Noncompetes, Google, Roll-Ups, and More
I’ll start with a bit of half-empty, half-full (and very partial) resolution in Federal Trade Commission (FTC) publicity. Losing by Winning or Just Losing or . . . ? A couple of weeks ago, the Wall Street Journal editorial board announced that: “Another Lina Khan Theory Loses in Court” And that was right, up to ... The Waiting Game: Noncompetes, Google, Roll-Ups, and More
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
