The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA). Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 FR 78500 (Nov. 8, 2016).

Congress enacted 505(q) with the purpose of ensuring that the FDA citizen petition process not be used to improperly delay the approval of pending abbreviated new drug applications (ANDAs), 505(b)(2) new drug applications (NDAs), or biologics license applications (BLAs) for biosimilars submitted under 351(k) of the Public Health Service Act (PHSA). Previously, where a petition related to approvability of an ANDA, for example, and where the matter had a high likelihood of ending up in litigation, petitions could have the effect of delaying final approval until the agency completed the petition process and finalized an administrative record that resolved the challenge.

Under 505(q), however, FDA is required to take final action within 150 days on a petition that requests any form of action that, if taken, may delay the approval of a currently pending ANDA, 505(b)(2) NDA, or 351(k) BLA. And, FDA is prohibited from delaying the approval of such an application because of a petition unless the agency determines that delay is necessary to protect the public health.

FDA’s final rule amends the existing regulations governing citizen petitions, which predate 505(q), and it clarifies the scope and requirements under 505(q). For example, it codifies the certification and verification requirements of 505(q) and confirms that these statements will be considered deficient if they do not match every word specified in the statute.

Perhaps most importantly, FDA interprets the statute to require a petitioner to include such a certification in some cases where the provisions of 505(q) are not applicable. The statute requires all petitions that are subject to 505(q) to include the necessary certification. Yet 505(q) applies only when two conditions are met: (a) an applicable ANDA, 505(b)(2) NDA, or 351(k) BLA is pending at the time the petition is submitted; and (b) the petition requests action that could delay the pending application. That is, the preexisting citizen petition process still applies to any petition that concerns issues unrelated to ANDA, 505(b)(2), or 351(k) approval, or that is filed before there is such an application pending. However, the statute did not resolve the issue of what certification to include with a petition that asks the agency to take action that could delay an ANDA, 505(b)(2) NDA, or 351(k) application – if there were one – but where the petitioner has no knowledge that such an application has been filed.

Because FDA will not review a petition that is subject to 505(q) if it is missing the required certification, and because the agency had previously announced that it may notify a petitioner if its petition is missing the correct certification, a petitioner could, for example, submit a petition without the 505(q) certification in an attempt to “smoke out” the existence of a pending ANDA.

Noting that there was no evidence that Congress intended to allow petitioners to use section 505(q) to obtain information about possible pending applications, FDA addresses this issue head on. It simply will requires all petitions that could delay approval of a pending application (if there indeed were one) to carry the 505(q) certification.

Finally, the new rule does not address FDA’s current practice of denying 505(q) petitions summarily after 150 days if the pending application remains under review. In response to a comment from PhRMA, FDA indicated that this practice would continue. We have dubbed these responses “non-denial denials.” On their face, they are a denial, but substantively, they defer engaging on the issue raised in the petition. These non-denial denials are nonetheless final agency action on the petition and allow the agency to meet its statutory obligation.