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FDA Proposes Simpler Updates for Generic Drug Labels

PHOTO: Attorney Allison Zieve with the watchdog group Public Citizen supports the FDA allowing manufacturers of generic drugs to update labels with newly-discovered information about risks or side effects, without a lengthy government approval process. Photo: Public Citizen.
PHOTO: Attorney Allison Zieve with the watchdog group Public Citizen supports the FDA allowing manufacturers of generic drugs to update labels with newly-discovered information about risks or side effects, without a lengthy government approval process. Photo: Public Citizen.
April 7, 2014

FRANKFORT, Ky. - According to Allison Zieve, an attorney with the watchdog group Public Citizen, most people are not aware that when they take a generic drug, they may have unwittingly given up some of their legal rights. She explained that that's the result of a 2011 Supreme Court ruling.

"If the labeling on a generic drug has failed to advise you of a safety risk, the Supreme Court has held you cannot sue the manufacturer for failing to warn you, unlike (the situation with) a brand-name company, which you could sue."

Zieve said the original FDA rules covering generic vs. brand-name drugs were written years ago, but now the agency is proposing a change that would make it easier for the makers of generic drugs, in many circumstances, to modify their labels when new information becomes available.

The update would allow label changes to add details such as newly discovered risks or side effects, without going through a government approval process.

"Now, rather than having a very small part of the market, generics have a huge part of the market, 84 percent of prescriptions filled," Zieve said. "So, the FDA rule is really a very important and overdue recognition that generic manufacturers need to be able to take responsibility for labeling."

Zieve pointed out that most people don't really choose whether they get generic drugs or not; that decision is often made by a doctor or pharmacist.

Often, generic drugs are much less expensive than name-brand drugs, which has accounted for their popularity. Zieve said people shouldn't feel that generic drugs are less safe than brand-name drugs, but it's wise to get the latest information about risks and side effects.

"The number of drugs that this has affected over the years is probably not huge," she said. However, the lawyer added, "The number of patients that have suffered because of the lack of adequate warnings is much bigger."



Greg Stotelmyer , Public News Service - KY