The US Food and Drug Administration (FDA) has issued a final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, to outline the issues that the agency will consider in citizen petitions and petitions for a stay of agency action to determine whether such petitions are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application.  A 505(b)(2) application is a type of new drug application to obtain the approval of a new drug that contains similar active ingredients to a previously approved drug and is used for changes in dosage form, strength, route of administration, formulation, dosing regimen, or new indication.

“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,” said FDA Acting Commissioner Ned Sharpless in a September 18, 2019 statement. “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.” The FDA announced its Drug Competition Action Plan in 2017 as a means to increase drug competition to lower the cost of prescription drugs. It subsequently has taken a series of actions and measures to improve the process for the development and review of generic drugs.

The FDA says the approach outlined in the guidance will help the FDA allocate resources when addressing petitions that may present an obstacle to the availability of generic drugs. Per the guidance, 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 under current regulations governing citizen’s petitions described in Section 505 (q) of the Federal Food, Drug and Cosmetic Act. The FDA says it 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 concerns.

The guidance describes what the FDA constitutes as a 505(q) petition and some of the factors the agency will consider in determining the purpose of the petition. Per the guidance, the FDA will consider whether the petition can be denied on the basis that it is serving as a deterrent and may in any case note this determination in the petition response, which is then posted publicly. By addressing challenges associated with this type of petition, the FDA says it aims to improve the efficiency and predictability of the drug-review process and to help drive down the costs of drug development.

Source: FDA