What You May Not Know About Generic Drugs
PHOTO: Attorney Allison Zieve with the watchdog group Public Citizen says it's time for the FDA to allow manufacturers of generic drugs to update labels with newly discovered information regarding risks and side-effects without going through a lengthy government approval process. (Photo supplied by Public Citizen)
March 11, 2014
MADISON, Wis. - Most people are not aware that when they take generic drugs, they may have unwittingly surrendered some of their legal rights because of a 2011 Supreme Court ruling, according to attorney Allison Zieve, director of litigation for the watchdog group Public Citizen.
"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 a brand-name company, which you could sue," Zieve explained.
The original FDA rules covering generic versus brand-name drugs were written years ago. Now the FDA is proposing a change that would allow the makers of generic drugs, in many circumstances, to modify their labels to add newly discovered risks or side effects, without going through a government approval process.
"Rather than having a very small part of the market, generics now 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 labelling."
She also pointed out that most consumers do not really choose whether they get generic drugs or not; that decision is often made by their doctor or pharmacist. She suggested discussing any concerns about the safety or side-effects of a drug with a doctor or pharmacist.
Often, generic drugs are much less expensive than name-brand drugs, which has accounted for their popularity. Zieve said people should not feel that generic drugs are less safe than brand-name drugs, but added that it is 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. The number of patients that have suffered because of the lack of adequate warnings is much bigger," she said.
The FDA is accepting comments until March 13 about this proposed change. Zieve suggested going online at http://FDA.gov to voice an opinion.