he final rule makes clear that the FDA will not delay the approval of pending ANDA, 505(b)(2) or 351(k) applications because of citizen petitions unless a delay is needed to protect the public health. The rule serves as a response to an uptick in petitions filed late that raise no valid issues and are designed only to prevent approval of a generic application. The FDA rejected several requested changes by PhRMA. 

The FDA issued a final rule updating its regulation regarding citizen petitions and petitions for stay of action (PSAs) requesting that the agency delay action on pending abbreviated new drug applications (ANDAs), 505(b)(2) applications or certain applications submitted under the Public Health Service Act (PHS Act). The final rule follows an uptick in petitions requesting the agency not approve certain applications unless certain requirements are met. Often these petitions raise scientific or legal issues related to the standards for approval, such as a particular method for demonstrating bioequivalence. Although these petitions may contribute to the FDA’s evaluation of an application when submitted early, petitions that are submitted late in the review process and do not raise valid issues may result in approval of an application being wrongly delayed.

The updated rule implements certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA). By enacting this provision, the FDA says Congress indicated its desire to ensure petitions are not used to wrongly delay approval of applications. Per section 505(q) of the FD&C Act, the FDA is not permitted to delay approval of a pending application because of any request, unless a request is in a citizen petition or PSA and it’s determined that a delay is required to protect public health.

The rule also clarifies that the FDA plans to respond to petitions within 150 days of receipt. It also makes clear that the FDA can dismiss a petition if changes in law, facts or circumstances since receipt render the petition null. This 150-day period is not to be extended for any reason, the FDA states. The FDA reserves the right to deny a petition at any time if it determines the petition was submitted with the goal of delaying the approval of an application without raising any valid issues. The FDA will be considered to have taken final action on a petition if it makes a final decision during the 150-day period or if the period expires without a final decision.

PhRMA had asked the FDA to revise the proposed rule to limit its application to cases in which there is evidence a relevant ANDA or 505(b)(2) application is pending, but the FDA declined to do so, saying the existence of a pending application is not made public by the agency and petitions could be therefore used to uncover the existence of such application. PhRMA also requested that the FDA put in place a method of notifying a petitioner if it’s determined that a delay of approval of an ANDA or a 505(b)(2) application is not required to protect public health. The FDA, however, said it wouldn’t do so, because section 505(q) of the FD&C Act doesn’t mandate such a notification. Additionally, PhRMA asked the agency to issue a regulation making clear that a delay in an approval of an application can be extended beyond the 150-day review period for a petition. The FDA said it wouldn’t do so, because uncertainty in predicting the time required to resolve a certain issue makes it impractical to establish an expectation of the length of delay. The FDA also declined to oblige PhRMA’s request that it abandon its practice of not providing a substantive response to every 505(q) petition, saying it is outside the scope of the rulemaking.

The FDA estimates the rule will result in one-time costs to industry of approximately $613,800, with annual costs of roughly $1,700. These equate to a total annualized cost of approximately $89,100. The total annualized costs include the administrative cost to review the rule, estimated at $87,400, as well as the cost for additional efforts to prepare certifications for petitions and verifications of both responses to petitions and supplements to petitions, pegged at $1,700.