Generic Drugs Will Soon be Able to Update Drug Warnings, FDA Says
The Food and Drug Administration (FDA) announced it will allow generic drug makers to make changes to their safety labels, allowing lawsuits to be filed against generic drug companies for the first time since a Supreme Court decision banned such suits two years ago.
The rule would also make it so that all manufacturers of the same drug would have to change their warning labels as long as the FDA approved safety changes for one manufacturer.
The FDA hopes to publish a proposal for the new regulation in September, at which time it will be open for public comment.
The regulation in place today only allows brand-name drug companies to update their safety information without FDA approval if they find out that there is a potential issue. Generic companies cannot make additions to their safety labels unless the FDA orders it or the brand-name manufacturer has already done so.
"We are extremely pleased to see that the Food and Drug Administration (FDA) today announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety," Dr. Sidney Wolfe, founder and senior adviser of the Public Citizen's Health Research Group, said in a statement.
"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 F.D.A. to pass 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 damage," according to the New York Times.