FDA Releases Final Citizen Petition Guidance for Section 505(q)
On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced the release of the final guidance document regarding citizen petitions subject to section 505(q) of the Federal, Food, Drug, and Cosmetic Act. Section 505(q), which was added by the FDA Amendments Act (FDAAA), states that the FDA shall not delay approval of pending Abbreviated New Drug Applications (ANDAs) for generic drugs as a result of citizen petitions that request FDA action.
Section 505(q) was designed to help prevent sham petitions, which are citizen petitions typically submitted to the FDA by pharmaceutical companies which hold patents to brand-name drugs in order to intentionally delay the approval of ANDAs submitted by manufacturer of generic versions.
The final guidance document outlines how the agency will treat petitions believed to be shams. The guidance details: (1) how section 505(q) applies to a particular citizen petition; (2) whether a petition would delay the approval of a pending ANDA; (3) the certification requirement; and (4) the verification of supplemental information.
Citizen petitions, including communication with the FDA intended to delay approval, must be submitted in writing pursuant to § 10.30 or § 10.35 and filed as comments in the appropriate docket. However, section 505(q) does not apply to petitions that could not under any reasonable theory delay the approval of a pending application, or to petitions submitted before September 27, 2007. Additionally, for section 505(q) to apply, the petition must concern a pending application at the time of submission.
A petition that meets the provisions of section 505(q) may not delay the approval of a pending application unless the FDA determines that a delay is necessary in order to protect the public health. The FDA provided two examples of public health issues that could necessitate a delay of the application: (1) whether a proposed generic drug is bioequivalent to the reference listed drug, and (2) whether an indication can be safely omitted from the labeling because the indication is patent protected. The FDA will evaluate if a petition delays the pending application by addressing whether the application would be ready for approval but for the issue(s) raised in the petition.
Pursuant to section 505(q), a petition must be certified by the petitioner to be considered for review by the FDA. The purpose of the certification is to ensure that the petitioner has disclosed all relevant information, both favorable and unfavorable, and verified the information is accurate. If the petition fails to include the exact language of the certification or complete date, the petition will not be reviewed. If a petitioner mistakenly submits a petition without the complete certification statement, he must submit a letter withdrawing the deficient petition and submit a new petition. The 180-day timeframe for the FDA response will begin upon submission of the new petition.
According to the final guidance document, the FDA timeframe to respond to a citizen petition could be tolled if the petition requests the FDA to take an action related to a specific aspect of a pending ANDA for which there is no final decision. A FDA response to a citizen petition should not interfere with an ANDA as a whole; therefore, a response may be issued beyond the timeframe if the petition is related to specific aspects such as a proposed trade name or specific claims proposed in the labeling.
We will continue to monitor the effects of the new citizen petition guidance and section 505(q). For more information contact us at email@example.com.