Citizen Petitions: FDA Sees Increase In Requests For Reconsideration, Serial Filings
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FDA is concerned that the number of citizen petitions requesting reconsideration of agency decisions, the filing of serial petitions by the same firm, and requests from non-innovator companies could delay the approval of generics. The agency voiced apprehension about these petitioning strategies in its second annual report to Congress on "Delays in Approvals of Applications Related To Citizen Petitions and Petitions for Stay of Agency Action" for fiscal year 2009. The report is mandated under the FDA Amendments Act of 2007. The law added a new subsection (q) to Section 505 of the Food, Drug, and Cosmetic Act which prevents FDA from delaying approval of an ANDA or 505 (b)(2) application – a type of new drug application seeking limited changes to a previously approved product – because of a citizen petition unless the agency determines that a delay is "necessary to protect the public health." The amended FDC Act also requires HHS to report annually to Congress on the number of ANDA and 505(b)(2) applications approved during the preceding 12-month period; the number of applications delayed by a citizen petition; the number of days of delay; and the number of petitions submitted. Three ANDAs Delayed In Two Years The reports indicate that citizen petitions are not delaying the approval of many applications. FDA reported that in fiscal year 2008 two ANDAs were delayed by citizen petitions and in fiscal year 2009 only one ANDA was delayed (see chart) But the agency has had to deal with a greater influx of petitions. In its second annual report, FDA said the number of petitions submitted during fiscal year 2009 increased by more than 47% over the number submitted during the first reporting period. The agency received 21 petitions in FY 2008 and 31 in FY 2009.
The agency is unsure whether the law is achieving its goal. "Although FDA now has two years of experience implementing section 505(q), it believes it may still be too early to make a determination as to whether section 505(q) is effectively discouraging petitions submitted with the primary purpose of delaying approval of an ANDA or 505(b)(2) application," the agency stated in its most recent report. FDA said it is concerned that it is continuing to receive petitions from ANDA and 505(b)(2) applicants and not solely from innovator companies. It also cited an increase in petitions for reconsideration that require it to readdress issues that have already been decided. And the agency noted that it frequently receives petitions from the same petitioner about a specific drug product or class of drug products that sometimes results in several responses about different aspects of the same product. "If these concerns become trends, they may undermine the goal of discouraging the submission of petitions that do not raise valid scientific issues and have the effect of improperly delaying approval of ANDAs or 505(b)(2) applications," the agency stated. Hyman Phelps & McNamara's Kurt Karst noted in a recent blog post that "FDC Act § 505(q) is not one of those statutory provisions, like the Prescription Drug User Fee Act or the Best Pharmaceuticals for Children Act, that is up for reauthorization at the end of Fiscal Year 2012." Nevertheless, "we would not be surprised if there is an effort to amend FDC Act § 505(q) to address some of FDA’s and industry’s concerns with the provisions and to make them more effective," the attorney wrote. "Despite the apparent drain on FDA resources, we think FDC Act § 505(q) has, if nothing else, provided more timely advice and greater transparency into FDA’s thinking on important Hatch-Waxman issues." FDA issued a draft guidance on its interpretation of section 505(q) in January 2009 (Also see "FDA Will Summarily Deny Petitions Submitted Solely To Block ANDA Approvals" - Pink Sheet, 28 Jan, 2009.). The agency told Congress it is considering issuing regulations through notice-and-comment rulemaking to further implement the law. FDA Encourages Early Citizen Petitions In a separate February 2009 report to Congress entitled "Encouraging Early Submission of Citizen Petitions and Petitions for Stay of Agency Action," FDA describes initiatives it has undertaken or is considering to get companies to submit petitions earlier. The agency said that between Oct. 1, 2003 and Sept. 30, 2006, FDA's Center for Drug Evaluation and Research received 213 petitions, of which one-third presented a legal or scientific challenge to the approval of ANDA or 505(b)(2) applications. Approximately 50% of petitions seeking to delay or block the approval of an ANDA raised issues associated with bioequivalence studies. FDA said that in the past, these petitions have frequently been submitted long after ANDA applicants have conducted bioequivalence studies for the drug. As a way to encourage the early submission of petitions the agency said it was considering whether it is appropriate to answer a petition raising bioequivalence issues with a brief response. FDA said it may do so if a draft bioequivalence guidance was published for the drug product at issue and the concerns raised in the petition were not submitted as comments to the draft guidance. Or, the agency said, it may do so if the petition is submitted more than a certain number of days after FDA publishes final guidance on bioequivalence studies for that drug. The agency said it also may issue a brief response to a petition that raises any issues pertaining to approval of an ANDA "if the petition is submitted more than a certain number of days after the filing of the first substantially complete ANDA using a particular listed drug as the basis of its submission and containing a paragraph IV certification." However, FDA said that "without any significant impediment to filing a late petition, such as summary denial, it may be difficult to encourage the early submission of petitions under 505(q)." FDA said it believes the statutory language allows summary denial only if the agency finds that the primary purpose of the petition is to delay approval of an application and the petition does not obviously raise valid scientific or regulatory issues. Therefore, FDA said it may summarily deny a petition only if it does not on its face raise valid or scientific issues. The agency added that this statutory standard "would be extremely difficult to meet." |
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