FDA to alter rules on generic drugs

Move could leave the makers of generic drugs open to lawsuits

New York TimesJuly 4, 2013 

The Food and Drug Administration signaled its intention Wednesday to permit makers of generic drugs to change their safety labels – a move that could open the door to lawsuits against the companies for the first time since a Supreme Court decision barred such actions two years ago.

Consumer advocates applauded the move, calling it a necessary fix for a system they say is unfair to patients who take generic medicines.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the FDA to make just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

Dozens of lawsuits against the makers of generic drugs have been dismissed since 2011, when the Supreme Court ruled that because the companies must, by law, use the same label warnings as the makers of brand name drugs, they cannot be sued for failing to alert patients to the risks of taking their drugs.

Last month, the Supreme Court ruled, on similar grounds, that patients may not sue makers of generic drugs by claiming that such drugs were defectively designed.

The FDA’s intentions came in the form of a bureaucratic step in which the agency must notify the Office of Management and Budget of its plans to publish a proposed rule. In a summary posted Wednesday on the budget office’s website, the FDA said the proposed rule would “create parity” between those who make generic and brand-name drugs with respect to how they update their labels – the lengthy list of a drug’s uses, dosages and risks.

Under the current system, makers of brand-name drugs can change a label if they receive important new information about their drug. If the FDA agrees the label change is necessary, the makers of generic counterparts also must change their labels. The rule change could allow makers of generic drugs to change their labels if they became aware of safety concerns, which could make them liable if a court were to find they failed to warn patients about potential harms.

The Generic Pharmaceutical Association, an industry group, declined to comment Wednesday.

The notice posted Wednesday indicates that the agency intends to publish a proposed rule by September, when the public would be asked to comment.

News & Observer is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere in the site or in the newspaper. We encourage lively, open debate on the issues of the day, and ask that you refrain from profanity, hate speech, personal comments and remarks that are off point. Thank you for taking the time to offer your thoughts.

Commenting FAQs | Terms of Service