Waxman attacks FDA preemption rule

The legal argument over preemption is already heating up again. You know the idea, that FDA approval shields drugmakers from state-court liability suits. The Supreme Court is set to rule on the idea in November, and each side is hinting at its strategies. The Vermont musician who sued Wyeth over its antinausea drug Phenergan, Diana Levine, filed one brief. Wyeth filed another that is perhaps more telling: It's narrowing the preemption argument.

At least in this case. Wyeth says that this isn't a failure-to-warn case, so ideas about FDA preemption in those cases don't apply. Rather, Levine's case has been based "on the theory that the FDA had the pertinent information but reached the wrong conclusion, and that the jury should set the FDA right. In this situation, state tort law is undoubtedly preempted." So it's all about the FDA, not Wyeth.

That's not how we read Levine's brief filed this summer, which argues that the issue is whether a drugmaker "may be held liable under state law for inadequately warning." But the standard disclaimer--that we're not lawyers--applies.

Meanwhile, the FDA may be attempting an end run on preemption--but Rep. Henry Waxman wants to stop it. In a letter sent yesterday, the chairman of the House oversight committee attacked a rule change that would preempt people from suing drug companies over risks disclosed on a drug's label. And this, Waxman said, "At a time in which FDA's own Science Board warns that 'American lives are at risk' due to chronic underfunding of the agency." The FDA hasn't replied to Waxman yet,  but whatever the agency says, this argument is far from over.

- read Rep. Waxman's letter to the FDA
- read the Wall Street Journal Health Blog item

Suggested Articles

Merck KGaA has big plans for a site in Switzerland where it intends to knit together biologics development and manufacturing. 

Biocon’s key biosimilars plant in Bengaluru, India, has gotten mixed reviews from the FDA and has now received a Form 483 with five observations.

Eli Lilly and Incyte are investing heavily in JAK inhibitor Olumiant's chances in atopic dermatitis, but does it stand a chance against Dupixent?