FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions

September 18, 2019

Media Inquiries

“A key area of focus in the FDA’s Drug Competition Action Plan is our work to deter brand-name drug companies from ‘gaming’ the system by taking advantage of certain rules, or exploiting loopholes, to delay competition. One of the anticompetitive tactics we’ve been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application. While the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process. Today we’ve issued a final version of a guidance for industry that addresses these concerns,” said FDA Acting Commissioner Ned Sharpless, M.D. “Also, to further dissuade companies from improperly using these petitions, the FDA will highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval. Importantly, the guidance outlines our intention to refer these matters to the Federal Trade Commission, the agency that oversees anticompetitive business practices. We hope this increased transparency will help reduce hurdles to drug development and approval.”

Today the U.S. Food and Drug Administration issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. It seeks to lessen the impact that FDA review of certain citizen petitions may have on any pending approval actions. The approach would help the FDA allocate resources efficiently when addressing petitions that are most likely to present an obstacle to the availability of generic drugs. 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 guidance states that the FDA would expect to respond to that petition within 150 days. This policy aligns the FDA’s 150-day timeline to review and respond to these petitions described in section 505(q) with the timeline for review of the applications themselves. The FDA will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval, as citizens petitions can raise relevant concerns.

The guidance describes the FDA’s current thinking on what constitutes a 505(q) petition and some of the factors the agency will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics. By addressing challenges associated with this type of petition, the FDA aims to improve the efficiency and predictability of the drug review process and to help to drive down the costs of drug development.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.