January 10, 2017
Authored and Edited by Yoonhee Kim; Paul W. Browning, Ph.D.
On November 8, 2016, FDA issued a final rule amending regulations governing citizen petitions, implementing section 505(q) of the FDCA as enacted by the Food and Drug Administration Amendments Act of 2007 and amended by the Food and Drug Administration Safety and Innovation Act on July 9, 2012. This final rule, which went into effect January 9, 2017, amended 21 CFR §§ 10.20, 10.30, and 10.35, and added § 10.31.
Citizen petitions are a means by which members of the public may petition FDA for certain actions, advise FDA of important issues, or present FDA with important information and feedback. Citizen petitions have been used historically for various purposes, including, for example, raising scientific and/or regulatory issues concerning the safety and efficacy of drugs, bioequivalence requirements, drug approval standards, FDA’s statutory interpretation, and drug labeling. Citizen petitions have been submitted by a wide variety of stakeholders including Members of Congress, hospitals, national professional organizations, government bodies, nonprofit advocacy groups, academics and students, as well as companies regulated by FDA and their trade associations. See Comments from Pharm. Research & Mfrs. of Am. to FDA, 2 n.3 (Apr. 2, 2012).
At issue in the final rule implementing section 505(q) of the FDCA, is a specific type of citizen petition under § 10.30—that relating to a request for FDA to take or refrain from taking an action relating to a pending ANDA, 505(b)(2) application, or biosimilar application. The final rule further applies to petitions for stay of action (“PSAs”) under § 10.35. The final rule appears to address criticism by some groups that citizen petitions and PSAs have been abused to improperly delay approval of applications relating to generic drugs. See 81 FR 78500, 78501 (Nov. 8, 2016).
Section 505(q) specifically provides that FDA must not delay approval of a pending application because of any request to take any form of action relating to the application, unless the request is in writing and in a citizen petition or a PSA, and FDA determines that “a delay is necessary to protect the public health.” Notably, the final rule states that FDA “intends” to respond to a citizen petition or PSA within 150 days after the date on which it is received. Id. at 78506 (adding 21 CFR § 10.30(e)(5)). This 150-day period is not extendable unless FDA determines that “a delay is necessary to protect the public health.” FDA further clarified additional steps petitioners must take in submitting such petitions, by codifying section 505(q)’s “certification and verification” requirements into § 10.31, and announced that FDA will consider their statements deficient if they do not match every word provided in the statute. Id. at 78501.
FDA has also addressed public comments concerning, among other things, the scope of § 10.31 and agency practices relating to citizen petitions and PSAs. FDA responded that § 10.31 applies to all petitions “regardless of whether an application subject to the petition’s requested action is pending at the time the petition is submitted.” Id. at 78503 (Response to Comment 1). This is arguably inconsistent with section 505(q), which provides that the statute applies to a “pending” application. Also, FDA indicated that it would continue its practice of denying a petition without comment after 150 days if the petition involves an issue regarding the approvability of a pending application on which FDA has not made a final determination. Id. at 78504 (Response to Comment 7).
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