FDA Approval Is Not A Shield

Generic drug manufacturers are not shielded from lawsuits over the safety of their products despite FDA approval, a federal judge has ruled.

On May 26, U.S. District Judge Berle M. Schiller refused to dismiss litigation brought by consumers who claim that Impax Laboratories and codefendant Teva Pharmaceuticals USA knew that their generic versions of Wellbutrin release the antidepressant’s active ingredient faster than the branded version sold by GlaxoSmithKline.

The suit alleges that the generics companies failed to warn patients and doctors about the different release rates. The consumers complained that because of the more rapid release, the generic drug, bupropion hydrochloride, was less effective in treating depression and more dangerous than the original drug.

Lawyers for Teva and Impax argued that the suit should be dismissed because FDA had determined that their generic versions are bioequivalent to the original Wellbutrin and are equally safe and effective.

But in a 29-page decision, Schiller asserted that a generic drug manufacturer is not absolved of liability because FDA has approved its generic product. Federal law, he wrote, “allows generic drug makers to expeditiously get their products to market—it does not allow generic drug makers to wash their hands of any responsibility for monitoring the safety and efficacy of their drugs once sold.”

Schiller cited the U.S. Supreme Court’s March 2009 ruling in Wyeth v. Levine, in which the justices held that FDA approval of a medication does not shield the brand-name manufacturer from liability under state law (C&EN, March 9, 2009, page 8). The ruling is one of the first applications of this high court decision.

Schiller concluded that generic drug manufacturers also have a duty to issue warnings about any new hazards that come to light after approval. “Levine teaches that the ultimate responsibility rests with the drug maker, not FDA, to either adequately inform the public or remove the drug from the market,” he wrote.

The case will now go forward in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia. Impax says it stands by its drug as a safe and effective product and “will continue to vigorously defend our position” in the litigation.

Chemical & Engineering News

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