SALT LAKE CITY – Allison Zieve, an attorney with the watchdog group Public Citizen, says most people are not aware that when they take generic drugs, they may unwittingly have surrendered some of their legal rights because of a 2011 U.S. 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,” she explains, “unlike a brand-name company, which you could sue.”
Zieve says the original U.S. Food and Drug Administration (FDA) rules covering generic versus brand-name drugs were written years ago.
Now, the FDA is proposing a change which 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.
“Now, rather than them having a very small part of the market, generics have a huge part of the market – 84 percent of prescriptions filled,” she explains. “So, the FDA rule is really a very important and overdue recognition that generic manufacturers need to be able to take responsibility for labeling.”
The FDA is accepting comments about this proposed change at <a href=”http://www.FDA.gov/” target=”parent”>FDA.gov</a>.
Zieve notes that most people don’t really choose whether they get generic drugs or not – that’s a decision often made by a doctor, pharmacist or insurance company.
She says concerns about the safety or side effects of a drug you’ve been prescribed should be discussed with your doctor or pharmacist.
Often, generic drugs are much less expensive than name-brand drugs, which accounts for their popularity.
Zieve says people should not 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 says. “The number of patients that have suffered because of the lack of adequate warnings is much bigger.”