FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same Old

By Kurt R. Karst –

FDA recently released the Agency’s Seventh Annual Report to Congress, required by FDC Act § 505(q)(3), on FDA’s experience during Fiscal Year 2014 (“FY 2014”) with citizen petitions subject to FDC Act § 505(q).  Other than some updated numbers fo FY 2014, the report largely repeats both FDA’s concerns about petitioning expressed in previous reports (see our previous posts here, here, here, here, here, and here) and the trends the Agency has been seeing in petitioning.  In particular, FDA notes: 

• FDA continues to receive 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 issues regarding 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.
• The enactment of FDASIA has increased the strain on Agency resources by significantly shortening the time frame for responding to 505(q) petitions by 30 days.  The shortened timeframe affords FDA even less time to evaluate the issues raised in the petitions and to provide a response that articulates the scientific and legal reasoning supporting the Agency’s decision.  As a result, FDA has needed to direct resources away from other important initiatives to attempt to comply with the new shorter deadline.
• 505(q) contains a provision that permits FDA to summarily deny a petition at any point if FDA finds that it was submitted with the primary purpose of delaying the approval of an ANDA, 505(b)(2) application, or 351 (k) application and the petition does not “on its face” raise valid scientific or regulatory issues (FD&C Act, section 505( q)(l )(E)).  As FDA previously noted in its Report to Congress, “Encouraging Early Submission of Citizen Petitions and Petitions for Stay of Agency Action” dated February 2009, we believe that the statutory language requires that both preconditions be present, and we believe this statutory standard would be extremely difficult to meet.  To date, FDA has never applied this provision to summarily deny a petition, despite the fact that, in FDA’s estimation, many 505(q) petitions do not in fact raise persuasive scientific or regulatory issues when those issues have been reviewed by FDA (as previously noted, approximately two-thirds of these petitions are denied in full).  Accordingly, it is FDA’s view that this provision has neither curbed the filing of petitions submitted with the primary purpose of delay nor has it permitted FDA to dispose of such petitions without expending substantial amounts of resources.
• The Agency continues to be concerned that section 505(q) is not discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues.  The statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns.  As a result, FDA remains concerned about the resources required to respond to 505(q) petitions within the 150 day deadline at the expense of completing the other work of the Agency.

To provide some context for the statements above from FDA, FDC Act § 505(q) was added to the law by the 2007 FDA Amendments Act (“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 Section 301 of Pub. L. No. 110-316 (2008), and again by Section 1135 of the 2012 FDA Safety and Innovation Act (“FDASIA”).  Among other things, FDASIA changed the original 180-day response deadline to 150 days, and made the law applicable to citizen petitions concerning biosimilar applications submitted to FDA pursuant to PHS Act § 351(k). In June 2011, FDA issued final guidance on FDC Act § 505(q).  That guidance was revised in November 2014 to account for changes made to the law by FDASIA.  In January 2012, FDA issued proposed regulations to amend the Agency’s citizen petition regulations to implement changes made to the law by Section 505(q).

Under FDC Act § 505(q), FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar 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.” FDA is required to “take final agency action on a petition not later than 150 days after the date on which the petition is submitted.”  FDA may not extend the 150-day period “for any reason,” including consent of the petitioner.  Although the statute provides that FDA may summarily deny a petition submitted with the primary purpose of delaying ANDA, 505(b)(2) application, or 351(k) biosimilar approval, the Agency has never done so, as noted above by FDA.

Perhaps the most noteworthy aspect of the Seventh Annual Report to Congress is the numbers.  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 Seventh Annual Report to Congress that:

During the FY 2014 reporting period, the Agency approved 39 505(b)(2) applications, 409 ANDAs, and 0 biosimilar biological product applications.  No approvals for ANDAs or biosimilar biological product applications were delayed because of a 505( q) petition in this reporting period.  One 505(b)(2) application approval was delayed in this reporting period because of a 505(q) petition.

The 505(b)(2) approval delayed in FY 2014 was delayed by 5 days because “FDA was concerned that if it approved the 505(b)(2) application 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 a drug product that did not meet the requirements for approval could negatively affect public health.”  Although FDA does not identify by drug name or application number the particular approval delayed, we suspect that the application at issue was NDA 205776 for RASUVO (methotrexate injection), and that the petition delaying approval was Docket No. FDA-2014-P-0318 (see our previous post ).

As to the number of 505(q) citizen petitions submitted in FY 2014, the Report to Congress says that 28 of the 102 citizen petitions (or 27%) handled by the Center for Drug Evaluation and Research (excluding ANDA suitability petitions and petitions that raise only OTC monograph issues) were 505(q) petitions.  That’s a hefty increase over FY 2013 when FDA received only 15 505(q) petitions.  “During FY 2008 through FY 2014, FDA received a total of 160 petitions subject to section 505(q).  Over this 7-year period, FDA responded to all but nine of the 505(q) petitions within the statutory time frame that was applicable during that period” (i.e., 180 days or 150 days).  The report includes helpful tables showing the percentage of 505(q) petitions received during Fiscal Years 2008-2014, and the outcomes for the 149 petitions that have been resolved under FDC Act § 505(q) as of September 30, 2014.