Drugmakers feel impact of preemption ruling

Previously rejected by the U.S. Court of Appeals for the Third Circuit in Philadelphia, lawsuits against GlaxoSmithKline and Pfizer were revived this week. Brought by relatives of patients who committed suicide after taking their products--Pfizer's Zoloft and Glaxo's Paxil--the suits claim the companies failed to warn that their antidepressants may cause suicidal tendencies. In Glaxo's case, the family of Lois Colacicco claimed that Glaxo and co-defendant Apotex, a Canadian generics maker, delayed adding a suicide risk warning to the drug's label until more than two years after the patient's death--long after two other drugs in the same class had suicide warnings added.

As you know, the Supreme's ruling last week effectively rejected the preemption argument that would have shielded drugmakers from liability for FDA approved drugs. But Glaxo and Pfizer argue that this case is different from the Wyeth v. Levine case because the FDA specifically evaluated the need for suicide warnings for adults, and decided against requiring a warning label. According to the U.S. Court of Appeals, the FDA studied the issue for 20 years and concluded that suicide warnings for adults "are without scientific basis and would therefore be false and misleading," Bloomberg reports (via Philly.com). Although in 2007 federal regulators did extend a warning for suicide risks among children to adults aged 18-24.

Last week's ruling did leave open the possibility that such product liability suits over warnings that the FDA had evaluated and rejected would be precluded. According to Justice John Paul Stevens, in the Wyeth case, the FDA hadn't considered a warning for the injection method.

- read the story at Philly.com for more
- check out Medpage Today's take

Suggested Articles

Alnylam is ready to follow on its Onpattro launch with an FDA nod for Givlaari. But the drug's safety profile is giving analysts reason to pause.

FDA nominee Stephen Hahn faced questions from Senators on Wednesday on topics including drug pricing, biosimilars, opioids and more.

BMS’ Opdivo-Yervoy combo been game-changing in late-stage melanoma. But when it comes to expanding the pair’s reach, the company has hit a roadblock.