Regulatory News

FDA proposal could speed safety information updates on generic drugs

A proposal would allow faster dissemination of new safety information about generic drugs to health professionals and patients, according to a press release from the U.S. Food and Drug Administration.

Currently, generic manufacturers must wait to update product safety information until the corresponding brand-name product has received approval to update its safety information. Under the proposed rule, generic drug manufacturers would be able to independently update product labeling with newly acquired safety information before the FDA’s review of the change, similar to the current process for brand-name drugs, the release said.

Generic manufacturers would have to inform the brand-name manufacturer about the change, according to the release.

The FDA would evaluate whether the proposed change is justified and make a decision on the labeling changes of the generic and brand-name drugs at the same time, so that they would ultimately have the same FDA-approved prescribing information.

To enhance transparency, the FDA plans to create a web page where safety-related changes proposed by all drug manufacturers would be posted and where members of the public could subscribe to receive updates, the release said.

The FDA will seek public comment on the proposed rule, which was announced in a Federal Register notice.

A proposal would allow faster dissemination of new safety information about generic drugs to health professionals and patients, according to a press release from the U.S. Food and Drug Administration.

Currently, generic manufacturers must wait to update product safety information until the corresponding brand-name product has received approval to update its safety information. Under the proposed rule, generic drug manufacturers would be able to independently update product labeling with newly acquired safety information before the FDA’s review of the change, similar to the current process for brand-name drugs, the release said.

Generic manufacturers would have to inform the brand-name manufacturer about the change, according to the release.

The FDA would evaluate whether the proposed change is justified and make a decision on the labeling changes of the generic and brand-name drugs at the same time, so that they would ultimately have the same FDA-approved prescribing information.

To enhance transparency, the FDA plans to create a web page where safety-related changes proposed by all drug manufacturers would be posted and where members of the public could subscribe to receive updates, the release said.

The FDA will seek public comment on the proposed rule, which was announced in a Federal Register notice.