Bexis recently gave the keynote address at the Minnesota State Bar Association’s annual FDA Forum.  In preparing his speech, which concerned recent challenges to FDA regulatory authority, Bexis had occasion to study Apter v. Dep’t of HHS, 80 F.4th 579 (5th Cir. 2023), which the blog previously discussed here. Since Bexis was discussing a variety of existing or threatened disputes over the FDA’s power, he simultaneously took a fresh look at the FDA’s pending draft guidance, Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cl ..read more

We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”). We normally try to keep our political views to o ..read more

On March 18, 2024, the Supreme Court heard argument in a matter, National Rifle Association of America v. Vullo, No. 22-842, that from its caption would seem to have nothing to do with our sandbox. But it might. One of the issues before the Supreme Court in NRA is whether administrative action, labeled only as “guidance” (in NRA, certain letters issued by the head of the New York State banking agency) were sufficiently coercive – despite not being presented as anything “final” – that they could unconstitutionally restrict speech in violation of the First Amendment.  Appellant NRA, represe ..read more

We’ve blogged several times already about the  Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court.  Briefly, a Texas District Court, in a decision that we’ve already described as “results-driven and shoddy,” purported to invalidate more than 20 years of FDA regulation – back to and including the original 2000 agency approval – of the abortifacient drug mifepristone, which would have had the effect of immediately removing from the market nationwide the safest and most commonly used drug for medication abortions.  See Alliance for Hippocratic ..read more

Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines.  But apparently even it has its limits—and Article III standing is one. In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several parents challenged the FDA’s emergency use authorization (EUA) that permits the administration of COVID-19 vaccines to children.  In essence, the plaintiffs sought to have the FDA’s regulatory decision overturned on the ground that the Agency failed to follow the Ad ..read more

If you work in this business long enough, you’ll run into some lawyers who check all the boxes: brilliant, persuasive, funny, and sartorially splendid.  One of the most talented lawyers we ever had the pleasure to work with was Peter Grossi.  He checked all the boxes, and then some.  When Peter was at Arnold & Porter, we co-tried a diet drug case with him.  It was a wonderful opportunity to watch a master on the job.  We never saw anyone better at keeping out the bad stuff and highlighting the good.  Peter retired from A&P a couple of years ago, and is now ..read more

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog.  Our position has been clear, and the same from the Blog’s beginning more than 15 years ago:  Truthful medically related speech from any source, including FDA-regulated product manufacturers, is First Amendment-protected scientific speech, and thus the FDA cannot constitutionally ban it by calling it “off-label promotion ..read more

The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely regulatory analysis, plenty of other commentary is available. These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices.  Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety ..read more

Lately, there seems to be an overdose of OTC (Over the Counter) drug cases. Everywhere we look, we see more and more lawsuits centered on OTC’s, both in the areas of product liability and consumer fraud.  Is it because OTC litigation offers plaintiff lawyers the prospect of a huge potential plaintiff population?  Is it because, unlike with prescription medications, plaintiffs can easily exaggerate or even make up the extent of their product usage? Is it because claims against OTC’s sidestep the pesky learned intermediary doctrine?  We have our suspicions.  In any event, mos ..read more

Our best college era summer job was working as a staffer for the New Jersey State Senate. The Abscam investigation was ongoing, and it seemed that every week there’d be another empty seat in the Senate chamber courtesy of the FBI. Good times.  We doubt we personally performed any services that were useful for Garden State taxpayers.  It was mostly an eye-opening experience for us.  Every week was a journey down some policy worm-hole. One day was spent with a representative of the state consumer affairs agency.  We were fiddling with proposed legislation. We don’t remember w ..read more