Generic Drug Labeling Rules Change Delayed by FDA, Placing Consumers at Risk: Group

Federal drug regulators have again postponed changes to the rules for generic drug warning labels, which some say would close a legal loophole that allows manufacturers to avoid liability for injuries caused by medications they sell that contain inadequate information about known side effects. 

The prominent consumer watchdog group Public Citizen criticized the move in a press release issued December 3, indicating that the FDA’s decision to once-again delay implementing rules originally proposed several years ago, which would allow generic drug makers to up date their warning labels, will place consumers at serious risk.

In November 2013, the FDA announced that it would implement new generic drug labeling rules, which would allow manufacturers of generic medications to update warning labels to add new information discovered about potentially dangerous side effects not disclosed by the manufacturers of the brand name drugs being copied.

The rules were supposed to be finalized this month, but earlier this year Public Citizen predicted that the agency would bow to industry pressure, and the FDA recently confirmed that implementation of the generic drug labeling rules will be delayed until at least July 2016.

“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” Dr. Michael Carome, director of the Public Citizen Health Research Group, said in a press release issued last week. “The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”

Currently, generic drug makers are prohibited from updating the warnings provided with their medications, even when they are aware that the label fails to provide accurate information about drug risks. Existing regulations require the copycat drugs to carry the same label information as the brand-name version of the medication. However, this has allowed generic drug makers to continue to profit off of medications that they know contain serious side effects of which doctors and patients may be unaware.

Generic drug makers have used this prior limitation of warning label updates as a shield against product liability lawsuits filed by consumers who suffered injuries while using the medications, arguing that such claims are barred since it is impossible to comply with the federal regulations and state-law failure to warn claims.

Known as federal preemption, the U.S. Supreme Court upheld this defense in the controversial 2011 ruling in Pliva v. Mensing, which has essentially granted generic drug makers immunity in failure-to-warn lawsuits over injuries caused by medications they manufacture and sell. Even when plaintiffs alleged that a generic manufacturer was aware that the labels on the brand-name version of the medication was inadequate, courts have granted motions to dismiss.

Under the new regulations, generic drug makers will be able to independently update product labeling with new safety information before the brand name drug is updated, or if the brand name drug is no longer sold. Manufacturers would be able to inform the FDA and the brand name manufacturer of the changes, and the FDA would review the new safety information.

With that option open to them, Courts are likely to find that generic drug manufacturers are liable for injuries caused by their failure to update warnings when information is discovered, multiple experts say.

The FDA has extended the comment period for the proposed rule in December 2013 and again in February 2015. The FDA has said that it is considering alternate proposals mentioned in the comments.

Previously, Public Citizen warned that these extensions were a sign that the agency may cave to industry pressure to allow generic drugs to continue to operate without requiring updated drug label safety information.