FDA’s Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns

April 3, 2012

By Kurt R. Karst –      
We recently got our hands on a copy of the latest report FDA submitted to Congress on citizen petitions covered by FDC Act § 505(q).  The report, titled “Third Annual Report On Delays In Approvals Of Applications Related To Citizen Petitions And Petitions For Stay Of Agency Action For Fiscal Year 2010,” is required by FDC Act § 505(q)(3), which was added to the law by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. L. No. 110-85 (2007), as amended by § 301 of Pub. L. No. 110-316 (2008).  We previously reported (here and here) on the other reports FDA submitted to Congress required by FDC Act § 505(q) and FDAAA.
FDC Act § 505(q) is intended to prevent the citizen petition process from being used to delay approval of ANDAs and 505(b)(2) applications.  Briefly, FDC Act § 505(q) provides that FDA shall not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  Under FDC Act § 505(q), which FDA has interpreted to apply only to certain petitions submitted to the Agency after September 27, 2007, “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.”  FDA may not extend the 180-day period “for any reason,” including consent of the petitioner, and may summarily deny a petition submitted with the primary purpose of delaying ANDA or 505(b)(2) application approval.  (FDA has only missed the 180-day timeframe twice between FYs 2008 and 2010.)  In June 2011, FDA published final guidance on 505(q) petitions, and in January 2012, FDA issued a proposed rule to amend the Agency's citizen petition regulations to implement FDC Act § 505(q).  Over the years, FDA Law Blog has vigilantly followed 505(q) petitions with our FDC Act § 505(q) Citizen Petition Tracker
Under FDC Act § 505(q)(3) each FDA annual reports to Congress must specify: “(A) the number of applications that were approved during the preceding 12-month period; (B) the number of such applications whose effective dates were delayed by petitions referred to in paragraph (1) during such period; (C) the number of days by which such applications were so delayed; and (D) the number of such petitions that were submitted during such period.”  FDA says in the FY 2010 report that:

During the FY 2010 reporting period, the agency approved 29 505(b)(2) applications and 426 ANDAs.  No 505(b)(2) approvals were delayed because of the filing of a 505(q) petition.  One ANDA approval was delayed by nine days because of a pending 505(q) petition.  Twenty 50S(q) petitions were filed during the reporting period.  FDA did not miss the statutory deadline for responding to any 505(q) petitions during this reporting period.

FDA’s decision to delay the approval of one pending ANDA by 9 days – only the fourth ANDA delayed due to a 505(q) citizen petition – was based on Agency concerns “that if it approved the ANDA before resolving the issues raised in the petition and later concluded that one or more of the arguments against approval were meritorious, then the presence on the market of drug products that did not meet the requirements for approval could negatively affect the public health.”  Those concerns were addressed when FDA completed its analysis of the issues raised in the petition.
FDA’s report goes on to identify several relevant “trends,” some of which were flagged in the Agency’s FY 2009 report as “areas of concern,” including:

  • Over the three year period during which we have been reviewing 505(q) petitions, the number of applications that have been delayed due to analysis of the issues raised in the 505(q) petitions is low: 4 ANDAs and no 505(b)(2) applications.
  • FDA continues to receive 505(q) petitions from ANDA and 505(b)(2) applicants, and not solely from innovator companies.
  • In many instances, the statutory deadline for responding to a 505(q) petition occurs before any related ANDAs or 505(b)(2) applications are ready for approval.
  • FDA has received seria1 505(q) petitions, frequently from the same petitioner, about the same specific drug or class of drugs, sometimes requiring several separate responses about different aspects of the same product. . . .  Responding to such serial petitions requires the use of substantial FDA resources, on a repeated basis, over a protracted period of time.
  • Since the passage of FDAAA, FDA has seen an increase in petitions for reconsideration of the agency's denial of 505(q) petitions, requiring the agency to readdress issues that already have been decided.

While FDA says that the jury is still out on whether or not FDC Act § 505(q) is accomplishing the stated goals of the legislation that created it, and that "additional experience and trend data are required," the Agency does express some concern that FDC Act § 505(q) "may not be discouraging the submission of petitions that do not raise valid scientific issues and are intended primarily to delay the approval of competitive drug products."  

Moreover, says FDA, "[w]e also believe that innovator companies may be implementing strategies to file serial 505(q) petitions and petitions for reconsideration in an effort to delay approval of ANDAs or 505(b)(2) applications for competing drugs."  Although not an instance of serial petition submission, FDA commented in a recent brief after being sued following the issuance of non-response denials to two petitions concerning quetiapine that "there is no evidence that Congress intended that 21 U.S.C. § 355(q) be used as a tool to allow NDA holders to seek advanced, substantive decisions from FDA so that they could seek judicial review of those decisions and effectively hold up approval of ANDAs.  Rather, Congress enacted this provision to prevent delays of ANDA approvals due to FDA’s consideration of issues raised in citizen petitions."  (Italics in original)  Additional analysis from FDA is expected in the Agency's next annual report on 505(q) petitions.