FDA Proposal Would Speed Release of Safety Information on Generic Drugs

On November 13, 2013, the FDA will publish a proposed rule in the Federal Register that, when finalized, will allow generic drug manufacturers to independently update and promptly distribute revised product labeling (also referred to as prescribing information or package inserts) to health professionals and patients just like brand name manufacturers do, i.e., before FDA review or approval of the change. This FDA proposal is intended to speed the dissemination of new safety information about generic drugs by allowing generic drug manufacturers to use the same streamlined process as brand drug manufacturers to update safety information in their product labeling. Comments on the proposed rule will be due 60 days after the date of publication.

Current Law

When new information becomes available that causes a drug product’s labeling to be inaccurate, both generic and brand drug manufacturers must take steps to update their labeling. Currently, however, generic manufacturers may not update their product safety information until the corresponding brand name product (the new drug application (NDA) holder for the reference listed drug (RLD)) has received FDA approval to update its safety information. In addition, brand drug manufacturers are currently allowed to independently update and distribute updated safety information to patients and health professionals prior to FDA approval by submitting a “changes being effected” (CBE-0) supplement to FDA. Generic manufacturers, however, must notify the FDA of new safety information, and wait for the FDA and the brand manufacturer to determine the updated labeling, which results in a delay in getting new information to health care professionals and patients.

Proposed Changes

Under the proposal, generic drug manufacturers would be able to independently update their product labeling with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do. Generic manufacturers would also be required to inform the NDA holder of the RLD (the brand name manufacturer) about the change. The brand manufacturer, in turn, would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug.The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.

If approval of the NDA for the RLD has been withdrawn for reasons other than safety or effectiveness, then the FDA’s evaluation of the labeling change proposed by the generic manufacturer would consider any submissions related to the proposed labeling change from any other application holder for drug products containing the same active ingredient(s).

Under the proposed rule, all generic manufacturers would be required to submit a CBE-0 supplement with conforming labeling changes within 30-days after FDA approval of a revision to the labeling for the RLD.

The proposed rule also would allow submission of a CBE-0 labeling supplement for certain changes to the “Highlights of Prescribing Information” for drug products with labeling provided in the Physician’s Labeling Rule (PLR) format. This proposal would remove an unnecessary impediment to prompt communication of the most important safety-related labeling changes (e.g., boxed warnings and contraindications) for drug products with labeling in the PLR format.

Finally, while FDA regulations currently allow the FDA to withdraw approval of a generic drug if its labeling is inconsistent with the labeling for the RLD, the proposed rule would add a new exception for generic drug labeling that is temporarily inconsistent with the labeling for the RLD due to safety-related labeling changes submitted by the generic holder in a CBE-0 supplement.

Web Page Postings

To make the safety-related changes to drug labeling described in a CBE-0 supplement readily available to prescribing health care providers and the public during FDA review, the agency proposes to establish a dedicated Web page on which it would post information regarding the labeling changes proposed in a CBE-0 supplement. Members of the public would be able to subscribe to receive updates of these postings.