FDA May Fold To Industry Pressure on Generic Drug Labels, Public Citizen Warns

A prominent consumer watchdog group Public Citizen is criticizing the FDA, warning that the agency is caving to pressure from industry groups and preparing to back off of new rules designed to make generic drugs safer, allowing manufacturers to update label information when they learn of new risks associated with the medications they sell. 

In a statement released last week, Public Citizen indicates that the FDA has delayed the release of new rules that would require generic drugs to carry up-to-date label warnings, and prevent the manufacturers from escaping liability when they sell medications with known side effects that are not disclosed to consumers or the medical community.

The FDA proposed new generic drug labeling rules in November 2013, which were supposed to be finalized in December. However, Public Citizen warns that may not happen.

Currently, generic drug makers are prohibited from updating the warnings provided with their medications, due to prior regulations that require the copycat drugs carry the same label information as the brand-name version of the medication. However, under those rules, generic drug makers have been able to continue marketing and selling drugs that have serious risks the manufacturer knows about, but that is not contained on the warning label for the brand-name drug.

Generic drug makers have used this prior requirement as a shield in product liability lawsuits filed by consumers who suffered injuries while using their 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.

The proposed rule by the FDA will likely change this and largely negate the preemption argument by generic drug makers.

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 generics industry has been lobbying hard against the rule,” Public Citizen warns. “In November, the GPhA (the generics trade group) and PhARMA (the brand-name trade group) sent the FDA a joint alternative to the FDA proposal. The industry alternative essentially says that after a generic manufacturer enters the market with a particular medication, neither the generic nor the brand-name manufacturer can update the safety warnings without prior FDA approval.”

Public Citizen said the alternative proposal was bad for patients because companies would not be required, nor have any incentive, to update the labels when new safety problems arose. The group also points out that it leaves no one accountable for injured patients when drug manufacturers fail to warn patients about newly discovered risks and would significantly slow down the labeling updates.

Public Citizen first called for the new rules in 2011, calling for the agency to amend the federal regulations that limit generic drug makers’ ability to update warning labels. The group indicated that the outdated regulations prevent consumers from learning about many known risks associated with generic drugs and has become a shield for pharmaceutical companies against product liability lawsuits.