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Revise Generic Drug Labeling, Petition Urges

Cheryl Clark, for HealthLeaders Media, August 30, 2011

But since generic makers selling most of the products, the generic makers hear about issues regarding side effects and effectiveness first, Zieve says. "The name brands no longer have the incentive to be paying as close attention. They're making a fraction of the money and selling a fraction of the prescriptions, yet they're the ones with the responsibility," she explained in a telephone interview.

When generic makers learn about potential side effects from their products, the FDA now requires them to tell the FDA about each instance, but not to immediately change their labels. The FDA has limited resources to monitor each safety event, Zieve says.

According to Public Citizen's petition, "some generic drugs may be associated with adverse events that do not occur with the name-brand drug," as in a case with Budeprion XL, "an example of a generic drug with side effects not associated with Wellbutrin XL, its brand-name counterpart." In that case, the generic manufacturer should have had an obligation to warn patients.

Asked for a response, a spokeswoman for the FDA said in an e-mail Monday that "the FDA will review the petition and respond directly to the petitioner once our review is complete."

The issue came to a head in June when the Supreme Court, in PLIVA v. Mensing, ruled that patients harmed by inadequate warnings on generic drug products can not sue generic makers for damages, but people who take brand name versions of the same drugs can. 

"In that case, the Supreme Court considered whether the restrictions imposed by federal law on the ability of generic drug manufacturers to alter labeling preempts state common law claims against a generic manufacturer based on failure to warn of hazards associated with its product," Public Citizen said in its petition.

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