FDA rule would allow faster product safety information updates for generics

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

The agency said Friday that the proposed rule would allow generic drug makers to use the same process as branded drug makers to update safety information in the product labeling before the FDA had reviewed it, thus allowing faster dissemination of information to healthcare professionals and patients. Generic drug makers would be required to inform the manufacturer of the branded drug of the change, and the FDA would then evaluate whether the proposed change was justified and make a decision of whether to approve the change for the branded and generic drug maker at the same time.

"This proposal will help ensure that healthcare professionals and consumers have access to the latest safety information for the medications they use," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date."

The Generic Pharmaceutical Association, a Washington-based trade group that represents generic drug companies, said it was in the process of reviewing the proposed rule.

“Patient safety is the foremost concern for manufacturers of generic medicines, which is why both brand and generic companies comply with federal law and strict FDA labeling rules and regulations," GPhA president and CEO Ralph Neas said. "Generic drug companies proactively participate with the FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements, to ensure doctors and all healthcare professionals and patients have access to the most up-to-date information."