FDA, Regulatory

Citizen petitions: FDA revises guidance to block drugmakers from abusing the system

The FDA on Tuesday issued a revised draft guidance designed to allow for the FDA to reject 505(q) petitions if the agency determines the primary purpose of the petition is to delay the approval of an abbreviated new drug application (ANDA).

“We believe this will provide an additional deterrent to pursuing these tactics,” the FDA said.

The new approach to reviewing petitions would also help the FDA focus its resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs.

“Once an application is submitted, the FDA has a goal date of making an approval decision on that application within 10 months, or, for some priority applications, within eight months. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the draft guidance states that the FDA would expect to respond to that petition within 150 days,” the FDA said.

Under the section, “How Does FDA Determine if a Petition Would Delay Approval of an ANDA, 505(b)(2) Application, or 351(k) Application,” the FDA explains issues that could implicate the public health include, for example, “(1) whether a proposed generic drug product is bioequivalent to the reference listed drug or (2) whether an indication can be safely omitted from the labeling because that indication is protected by a patent.”

To further dissuade companies from improperly using these petitions, the FDA also said it intends to highlight in its annual report to Congress the determinations of petitions that are judged to have been submitted to delay an approval. The guidance also outlines the FDA’s intention to refer these matters to the Federal Trade Commission.

Other questions answered in the guidance include, “How Does FDA Determine if Section 505(q) Applies to a Particular Petition?” and “What Is the Relationship Between the Review of Petitions Under Section 505(q) and the Review of ANDAs, 505(b)(2) Applications, and 351(k) Applications for Which the Agency Has Not Yet Made a Final Decision on Approvability?” and “What Considerations May Suggest That a Petition Was Submitted for the Primary Purpose of Delaying Approval of an Application?”

This 17-page guidance, updating a previous version from 2014, also describes how FDA interprets the provisions of section 505(q) requiring that (1) a petition include a certification and (2) supplemental information or comments to a petition include a verification.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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