23,485 petitioners tell FDA: Finish the generic drug safety labeling rule now!

With your help, 23,485 people have signed our petition to the FDA, calling on the agency to promptly finalize its rule that would enable up-to-date safety warnings on generic drugs.

The petition was submitted to the FDA on Monday by Tammy Gilbert, of Ohio. Gilbert lost her 22-year-old daughter, Kira, who took a generic form of the pain medicine Darvon, after tearing her ACL. Within days, she died from an acute cardiac failure. She and her family had not known that there had been growing evidence of the danger of the drug, because there was no such warning on the drug's label. The FDA would later completely ban the drug.

Tammy Gilbert couldn’t even hold the drugmaker accountable in court for failing to warn of the associated risks – because it was a generic drug.

The labeling problem is widespread because generic drugs now make up 80 percent of all prescriptions filled in the United States. Generic drug manufacturers are not allowed to independently update their labels to warn of newly discovered side-effects. And they can’t be held accountable if their drugs injure or kill Americans. It’s a generic drug safety loophole.

The FDA has proposed a plan to fix the problem that will enable generic drugmakers to independently update their safety labeling, and to be held accountable if their labels don’t warn of safety risks. Unfortunately, the plan is under attack by the generic drug industry; it has already been delayed once, and it could be delayed again.

Our petition was submitted into FDA’s official rulemaking docket as a public comment. We’ll let you know what happens next!