FDA Must Protect Patients from Defective Generic Drugs

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For Immediate Release: March 9, 2012

Contact: Katie Gommel
American Association for Justice
202-965-3500 x8369
AAJ Press Room

FDA Must Protect Patients from Defective Generic Drugs

Generic drug makers should be required to update their warning labels independent of brand name manufacturers

Washington, DC—The U.S. Food and Drug Administration (FDA) should require generic drug manufacturers to update their warning labels to protect patients from previously unknown side-effects, according to the American Association for Justice.

The FDA today asked for more time to respond to Public Citizen’s petition calling for a regulation change that would force generic manufacturers to update their labels. The petition was filed in August 2011 after the U.S. Supreme Court’s decision in Pliva v. Mensing.

In Mensing, the Court held that generic drug manufacturers must follow the brand name’s warning labels even if new side effects were discovered and the brand name drug has left the market. Gladys Mensing developed a severe, irreversible neurological disorder after taking a generic form of Reglan, but could not hold the manufacturer accountable because the pharmacist filled her prescription with a generic. Thousands of patients have had their cases dismissed simply because they took a generic drug and not a brand name.

AAJ filed comments last week in support of the Public Citizen petition, which asked the FDA to initiate a rule change mandating a generic manufacturer to update its warning label if the brand name manufacturer’s market share dropped below 20% six months after the drug has gone generic.

This would allow generic manufacturers to independently change their labels through the changes-being-effected (CBE) and prior-approval-supplement (PAS) procedures without having to rely on brand manufacturers – which have little incentive to monitor the safety of a drug that has gone generic and is no longer profitable.

“The FDA must ensure the safety of the expanding generic drug market,” said AAJ President Gary M. Paul. “Accountability is the only incentive drug companies have to monitor and adequately warn patients about the safety of their drugs.”

AAJ’s comments in support of Public Citizen’s petition to the FDA can be found here.

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