FDA’s Fourth Annual Report to Congress on 505(q) Citizen Petitions; Agency Continues to Express Concerns About the Use and Effects of 505(q)

January 22, 2013

By Kurt R. Karst –      

Late last year, FDA submitted to Congress the Agency’s latest report on FDC Act § 505(q) citizen petitions.  The report, titled “Fourth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions For Stay of Agency Action for Fiscal Year 2011,” is required by FDC Act § 505(q)(3).  We previously reported (here, here, and here) on the other reports FDA submitted to Congress required by FDC Act § 505(q) and the FDA Amendments Act (“FDAAA”), Pub. L. No. 110-85 (2007).  The latest report provides updated numbers required by the law, and although it reiterates some of the trends and concerns expressed in the Third Annual Report, the Fourth Annual Report also focuses on the use of Agency resources to respond to 505(q) petitions.

By way of background, FDC Act § 505(q) was added to the law by FDAAA and is intended to prevent the citizen petition process from being used to delay approval of pending ANDAs and 505(b)(2) applications.  The law was amended by § 301 of Pub. L. No. 110-316 (2008), and again by § 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. L. No. 112-144 (2012).  The changes made by FDASIA (see our FDASIA summary here) are not directly relevant to the latest FDA report, which covers the period of October 1, 2010 to September 30, 2011.  Under the version of FDC Act § 505(q) in effect for the Fourth Annual Report, the statute says 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 never summarily denied a 505(q) petition, but was recently asked to do so (Docket No. FDA-2012-P-1028).  (Among other things, FDASIA changed the 180-day period to 150 days, and makes the law applicable to citizen petitions concerning biosimilar applications submitted to FDA pursuant to PHS Act § 351(k).)

FDC Act § 505(q)(3) requires that each annual report to Congress 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 its Fourth Annual Report that:

During the FY 2011 reporting period, the agency approved 43 applications submitted under section 505(b)(2) and 458 ANDAs.  No 505(b)(2) approvals were delayed because of the filing of a 505(q) petition in this reporting period.  One ANDA approval was delayed by 78 days because of pending 505(q) petitions.

FDA’s decision to delay the approval of one pending ANDA by 78 days – only the fifth ANDA delayed due to a 505(q) citizen petition (no 505(b)(2) applications have been delayed) – was based on the same Agency concern expressed in the Third Annual Report for delaying the approval of an ANDA: “that if [FDA] approved the ANDA before resolving the issues raised in the petitions 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 public health.”  Those concerns were adequately addressed when FDA completed its analysis of the issues raised in the petition.  FDA approved the ANDA on the same dat the Agency responded to the petition.  FDA also notes that the 78-day delay did not affect the marketing of the generic drug, because the ANDA sponsor was enjoined in Hatch-Waxman patent infringement litigation from marketing the drug product for several years. 

Moving on to issues concerning petition review and FDA’s observations, the Fourth Annual Report provides some consolidated numbers from FYs 2008-2011.  According to FDA, the Agency has received a total of 92 petitions subject to FDC Act § 505(q), and the annual number of petitions has remained relatively steady, with the exception of FY 2009:

FDA has timely responded to all but two of the 505(q) petitions within the 180-day statutory timeframe.  Over the years, FDA Law Blog has vigilantly followed 505(q) petitions with our FDC Act § 505(q) Citizen Petition Tracker.  We recently modified the tracker (and are continuing to do so) to include non-505(q) petitions and renamed it the “FDA Citizen Petition Tracker.” 

FDA’s Fourth Annual Report also identifies petitioning trends, some of which were flagged in previous annual reports:

  • 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.  Accordingly, a relatively small percentage of applications are delayed by these petitions.
  • Over the 4-year period during which FDA has been reviewing 505(q) petitions, approximately 5% of the petitions resulted in a delay in approving an ANDA. 
  • FDA continues to receive 505(q) petitions from ANDA and 505(b)(2) applicants, and not solely from innovator companies.
  • FDA has received serial 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.  In addition, petitioners are raising their arguments serially, rather than asserting all available arguments in the first petition filed.  In the FY 2011 reporting period, for example, the agency received its fourth 505(q) petition relating to the approval of ANDAs for topical ophthalmic products and a third 505(q) petition related to Doryx (doxycycline).  The various submissions raised different scientific issues, requiring serial review of different arguments, rather than one comprehensive review of all pertinent arguments.  The agency responded to all of these petitions within the statutory deadline.  Responding to such serial petitions requires the use of substantial FDA resources, on a repeated basis, over a protracted period of time.

The petitions concerning DORYX were noted in a lawsuit that Mylan Pharmaceuticals Inc. filed in the U.S. District Court for the Eastern District of Pennsylvania alleging that Warner Chilcott and Mayne violated Sections 1 and 2 of the Sherman Act by engaged in so-called “product hopping” with respect to DORYX (see our previous post here). 

As opposed to previous annual reports in which FDA seems to have been more tentative in its critique of FDC Act § 505(q), the Agency, it its Fourth Annual Report, seems to take a slightly more definitive position and expresses greater frustration with how responding to 505(q) petitions interferes with other Agency work.  (As we previously reported, one recent analysis has concluded that FDC Act § 505(q) has been unsuccessful.)  The following paragraph concludes the Fourth Annual Report, and is simialar to language from the Third Annual Report with the exception of the highlighted text:

FDA will continue to gain additional experience and monitor trend data in the FY 2012 reporting period to assist Congress in determining whether section 505(q) is accomplishing the stated goals of the legislation.  Based on the petitions that FDA has seen to date, however, the agency is concerned that section 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.  Though many 505(q) petitions do not necessarily raise issues that are important to the public health, the statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns.  FDA also believes 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.  FDA remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing the other work of the agency. [(Emphasis added)]

With the 30-day haircut to the 180-day response timeframe made by FDASIA and the expanded scope of petitions subject to FDC Act § 505(q), FDA’s frustration may only increase.  As we previously noted, in late 2012, FDA was faced with a 505(q) petition “perfect storm” as the result of the convergence of pre- and post-FDASIA response deadlines in which 13 505(q) petition responses were due between November 14 and December 15, 2012.  FDA appears to have weathered that storm pretty well.  FDA is now facing an “opioid spring” of sorts in which responses to several petitions (among other things) relating to opioid abuse are due.