The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

Generic Drugmakers to Inherit Safety Labeling Update Powers Under FDA Rule

Nov. 29, 2013

The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have.

Under a new proposed rule, generic manufacturers would make the labeling change by filing a “changes being effected” supplement (CBE-0) for their drugs. The CBE-0 should contain:

  • The application number of the drug product(s) involved;

  • A description of the labeling change proposed in the supplement;

  • The basis for the change, such as data from adverse event reports or published literature;

  • A copy of the product labeling proposed in the CBE-0 supplement; and

  • Confirmation that the brand drugmaker was notified of the CBE-0 supplement.

Under current law, a branded drugmaker usually implements labeling changes around the time it submits the CBE-0 supplement. The FDA will review the supplement and then either approve it or send a letter to the drugmaker with proposed changes. Currently, generic makers must wait for agency approval before implementing the change.

The agency plans to post CBE-0s for NDA, ANDA and BLA products on a new web page. Because of this new feature, the agency wants all CBE-0s to be submitted in a structured product labeling format that can be posted online, the FDA said.

The proposed rule touches on issues raised in a 2011 Supreme Court decision in the case of Pliva v. Mensing. In that case, the court rejected the notion that generic companies have an obligation to request label changes after new adverse events were found.

“The federal statutes and regulations that apply to brand-name drug manufacturers differ, by Congress’ design, from those applicable to generic-drug manufacturers,” Justice Clarence Thomas wrote for the majority. The FDA and Congress may change the laws and regulations if they desire, he adds.

GPhA Nov. 8 questioned if the agency has the authority to issue the rule in the wake of the court’s decision.

The group also said it is concerned that multiple generic drugmakers could file conflicting safety information for the same generic product, leading to “unnecessary confusion and uncertainty for prescribers and patients.”

GPhA said it is reviewing the proposed rule, evaluating it “both for any elements that could impact patient safety, and for our member company business practices.”

The proposed rule was published in the Federal Register Nov. 13. The public has until Jan. 12 to comment.

The ability to amend labeling is a major change … but what else is there to know about the proposed rule? Come find out, at FDA’s New Generic Drug Safety Labeling Rule, the webinar that will clear up all of your labeling concerns. Sign up here.