FDA Moves to Make Generic Drugmakers More Accountable


Generic drug makers, who fill 84% of prescriptions in the U.S., are required to copy the labels of their brand-name equivalents verbatim. Because they have no control over the safety warnings’ content, the U.S. Supreme Court ruled in 2011 that generic drug manufacturers cannot be held liable if the drug ends up hurting a patient. 

As pointed out in the Today Show story below, a new rule proposed by the U.S. Food and Drug Administration (FDA) on November 8th could change everything. The rule, which will enter a stage of public comment before possible approval, would allow generic drug makers to update safety labels with new information.  This means generic manufacturers can’t hide behind the brand name drug’s label even when they know about safety risks.  The generic manufacturers could also be held liable if a court determined that they failed to warn patients about potential harms.

We are hopeful that the FDA’s new rule will be approved.  It will hopefully give people access to critical safety information sooner, and will also allow them to exercise their legal rights when generic drug manufacturers hide risks. – SK

FDA Moves to Make Generic Drugmakers More Accountable
by Jeff Rossen and Avni Patel
Today Show
November 8, 2013

Viola Purcell can’t even drink a bottle of water without choking. She twitches uncontrollably and has trouble breathing and eating. She says it all started after her doctor prescribed a generic drug for acid reflux.

“I was a happy person and I liked to smile, and I can’t smile now,” she said, breaking into tears. “There’s no smile in there.”

She took the prescription drug, metoclopramide, for more than five years, thinking it was safe.

“The doctor told me that ‘this is going to make you feel better,'” Purcell said. “But it didn’t; it only got worse.”

She stopped taking the drug in 2009 after the FDA issued a warning that long-term use of metoclopramide can cause a neurological disorder called tardive dyskinesia, the same condition Purcell now suffers from. So she tried to sue the drugmakers, saying the warning label for her pills was “misleading” and “inadequate.”

But the court threw out her case based on a 2011 Supreme Court ruling. In a 5-4 decision, the justices found generic drugmakers can’t be sued because, under current FDA rules, only name-brand drugmakers are responsible for safety warnings. Generics are required to copy the label from the name brand and have no control over what’s on it, so as a result, they can’t be held liable.

“If you take a brand-name drug, you still have your rights to go to court and hold them accountable,” said Purcell’s attorney, Larry Jones. “If you take a generic drug, you have no rights. And most people don’t realize that.”

But a new FDA proposal could change that in the future. On Friday the agency announced a proposed rule that would allow generic drugmakers to update labels with new information, just like brand manufacturers, and potentially open them up to liability. The proposed rule comes more than two years after the watchdog group Public Citizen first petitioned the FDA to close what it called a dangerous safety gap…
Click to see the full story.