Fill the safety gap with generic drug prescriptions: Legislation would direct FDA with labeling

Current Federal Drug Administration regulations require a generic drug’s labeling to be the same as its brand-name counterpart.

Brand-name drug manufacturers are able to update product labels with new safety warnings without FDA approval, according to a press release, but generic manufacturers must get FDA approval.

Last week, Congressman A. Donald McEachin of Virginia introduced the Updated Drug Labeling for Patient Safety Act. The legislation would direct the FDA to allow generic drug manufacturers to update product labeling with safety-related information.

“Patient safety should be of paramount concern; however, current FDA regulations fall short with regards to generic drug labeling,” McEachin said in the press release. “With over four in five prescriptions in the United States filled by generic drugs, it is imperative that we update the labeling process to ensure Americans are better informed about potential side effects and can make the best decisions, in consultation with their physicians, for their health and well-being. The Updated Drug Labeling for Patient Safety Act is commonsense legislation that will close this safety gap and improve health outcomes for more Americans.”

The bill would direct the FDA to issue a final rule establishing a process to allow generic drug manufacturers to update drug labeling, and to conform the labeling of brand-name and generic drug products. The FDA would also be directed to implement the final rule promptly within 180 days.

The legislation is endorsed by Public Citizen and the American Association for Justice.

“No drug is safe in all situations; a drug is safe when used in accordance with labeling that accurately reflects known risks,” Michael Carome, Director of Public Citizen’s Health Research Group, said in the press release. “Allowing generic drug companies to make safety updates to their products labeling, as this bill aims to do, would fill a safety gap and better protect public health.”

According to Linda Lipsen, CEO American Association for Justice, brand manufacturers “lose all incentive to keep drug labels up to date after a drug goes generic. If a generic drug manufacturer wants to reap the profits from the medicine, they must ensure patients are kept apprised about the latest safety information.”