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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 courtesy Public Citizen.
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 courtesy Public Citizen.
March 31, 2014

LANSING, Mich. - When people take generic drugs, they may be unwittingly surrendering some of their legal rights, according to Allison Zieve, an attorney with the watchdog group Public Citizen, who explained that that's because 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 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 FDA is proposing a change which would allow 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.

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

Often, generic drugs are much less expensive than name-brands, which accounts for their popularity. Zieve said people should not feel that generics 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. "The number of patients that have suffered because of the lack of adequate warnings is much bigger."

Zieve also noted that most people don't really choose whether they get generic drugs: that decision is often made by a doctor or pharmacist. She added that if you have concerns about the safety or side effects of a drug you've been prescribed, that's who you should discuss it with.

Mona Shand, Public News Service - MI