FDA’s Sixth Annual Report to Congress on 505(q) Citizen Petitions: Agency Says Provision Has Not Been Effective in Curbing Frivolous Petitions

By Kurt R. Karst –

FDA’s Sixth Annual Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience during Fiscal Year 2013 (“FY 2013”) with citizen petitions subject to FDC Act § 505(q), though largely repetitive of reports filed for previous fiscal years (see our previous posts here, here, here, here, and here), includes more forceful statements about the effects of the statutory provision than we have seen in the past from the Agency. The report also includes updated figures and statistics on the numbers and outcomes of petitions FDA has received and acted on.

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. Instead, FDA seems to have resorted to a form of public shaming when the Agency suspects delay tactics (see our previous post here).  But outright denial of a 505(q) petition is clearly something that’s been on FDA’s mind. In the latest Report to Congress, FDA comments:

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 or 505(b)(2) 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 entitled “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 frivolous petitions submitted with the primary purpose ofdelay, nor has it permitted FDA to dispose of such petitions without expending substantial amounts of resources.

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 Sixth Annual Report that:

Between September 27, 2007, and September 30, 2013, FDA determined that a delay in approving an ANDA was necessary to protect the public health in the case of seven ANDAs with related 505(q) petitions. FDA has not delayed approval of any 505(b)(2) applications or biosimilar biological product applications based on 505(q) petitions.

During the FY 2013 reporting period, the Agency approved 37 applications submitted under section 505(b)(2), 440 ANDAs, and no biosimilar biological product applications. No approvals for any 505(b)(2) or biosimilar biological product applications were delayed because of the filing of a 505(q) petition in this reporting period. Two ANDA approvals were delayed in this reporting period because of pending 505(q) petitions.

The two ANDA approvals delayed in FY 2013 were delayed by 25 days because “FDA was concerned that if it approved the ANDAs before resolving the issues raised in the petition and later concluded that one or more ofthe 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.” Although FDA does not identify by drug name or ANDA number the particular approvals delayed, they are clearly ANDAs affected by FDA’s consideration of a March 2013 citizen petition (Docket No. FDA-2013-P-0247) concerning Zoledronic Acid Injection. FDA denied that petition in August 2013 and specifically noted that the petition caused a 25-day delay in ANDA approvals.

As to the number of 505(q) citizen petitions submitted in FY 2013, the Report to Congress says that 15 of the 93 citizen petitions (or 16%) 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. “During FY 2008 through FY 2013, FDA received a total of 131 petitions subject to section 505(q). Over this 6-year period, FDA responded to all but six 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 2008-2013, and the outcomes for the 124 petitions that have been resolved under FDC Act § 505(q) as of September 30, 2013. Our friends over at RAPS have also put together some tables based on the data reported by FDA (see here).

In previous Reports to Congress, FDA has repeatedly expressed frustration with how responding to 505(q) petitions interferes with other Agency work.  FDA’s Sixth Annual Report is no exception. If anything, FDA is expressing more frustration as the years go by:

The Agency is concerned that section 505(q) is not discouraging the submission of petitions that are intended primarily to delay the approval ofcompeting drug products and that 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. FDA also believes that innovator companies are, in some cases, implementing strategies to file serial 505(q) petitions and petitions for reconsideration in an effort to delay approval ofANDAs or 505(b)(2) applications for competing drugs. In addition, with the shortened timeframe under FDASIA, 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.

Whether FDA’s growing frustration will boil over into something more – perhaps a change in the law – remains to be seen.