WASHINGTON – The Food and Drug Administration announced plans Wednesday to give generic drug manufacturers permission to change safety labels on drugs when new information about potential risks is discovered.
This comes after years of petitioning from consumer watchdog groups such as Public Citizen, which issued a report last week calling on the FDA to make it easier for generic drugmakers to update safety labeling.
Long after a drug is put on the market, pharmaceutical companies often become aware of new risks associated with the drug. Under current rules, brand-name drugmakers can change their labels without FDA approval, while generic drug makers are restricted from updating safety labels to reflect new information unless it meets certain criteria.
Generic manufacturers can only change product labeling if ordered by the FDA to do so or if its brand-name equivalent already has made a similar change. Yet the Public Citizen report lists 434 generic drugs for which no comparable brand-name product exists.
Health research experts at Public Citizen sought to revise FDA rules, noting that generic drugs have become immensely popular over the past few decades. Last year 80% of prescriptions filled in the U.S. were for generic drugs.
But generic drugmakers prefer to leave the FDA in charge of labeling, according to the industry’s trade association.
“Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions,” said Ralph Neas, president of the Generic Pharmaceutical Association.
In a 5-4 ruling last week, the Supreme Court protected generic drug companies from being sued for any harmful effects of drugs the FDA has approved. Two years ago, the high court ruled that inadequate labeling of a generic drug was not cause for a lawsuit against the maker.
Branded drugs, in contrast, are liable if a product’s safety label is inadequate. This causes a “regulatory gap” between generic and brand-name product safety, Public Citizen said.
The FDA said the proposed new rule would make generic and brand-name producers equal with respect to updating safety labeling. Public Citizen said it was pleased with the FDA’s decision.
“The proposed rule is a classic example of harm reduction,” Dr. Sidney Wolfe of Public Citizen’s health research group said in a statement. “When finalized…it will provide added protection to the tens of millions of people who regularly use generic drugs.”