By Kurt R. Karst –
Q. Why did the chicken cross the road?
A. To get to the other side.
Q. Why did the turtle cross the road?
A. To get to the shell station.
Q. Why did the duck cross the road?
A. To prove he wasn’t chicken!
Q. Why did the cow cross the road?
A. To get to the udder side!
Q. What happened when the elephant crossed the road?
A. It stepped on the chicken!
Q. Why did the . . . . . Well, you get the drift. The same old joke can be dressed up a bit, but the punchline ultimately remains the same. That’s kind of how we view FDA’s Eighth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015. The report, which is required by FDC Act § 505(q)(3), gives us the low-down on FDA’s experience during Fiscal Year 2015 (“FY 2015”) with citizen petitions subject to FDC Act § 505(q). Other than some updated numbers for FY 2015, however, the report largely repeats both FDA’s concerns about petitioning expressed in previous reports (see our previous posts here, here, here, here, here, here, and here) and the trends the Agency has been seeing in petitioning. (And to make our point on repeating the same punchline, the preceding sentence is almost identical to the sentence we used in our post on FDA’s FY 2014 Report to Congress.)
By way of background, 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). FDA appears to be nearing completion of a final rule (see here).
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.
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 . . . 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 Eighth Annual Report to Congress that:
During the FY 2015 reporting period, the Agency approved 492 ANDAs, 45 505(b)(2) applications, and 1 biosimilar biological product application. The approval of one 505(b)(2) application was delayed because of one 505(q) petition, and the approval of one ANDA was delayed because of two 505(q) petitions. No approvals for biosimilar biological product applications were delayed because of a 505(q) petition in this reporting period.
The ANDA and 505(b)(2) approvals were delayed by 141 and 44 days, respectively. “FDA was concerned that if it approved the ANDA and 505(b)(2) applications 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 a drug product that did not meet the requirements for approval could negatively affect public health,” says FDA in the report (in what is now boilerplate language. FDA does not identify by name or application number the particular approvals delayed.
As to the number of 505(q) citizen petitions submitted in FY 2015, the Report says that 15 of the 74 citizen petitions (or 20%) 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 7% decrease compared to FY 2014 when FDA received 28 505(q) petitions. “From FY 2008 through FY 2015, FDA received a total of 175 petitions subject to section 505(q). Over this 8-year period, FDA responded to all but 11 of the 505(q) petitions within the statutory time frame that was applicable during that period” (i.e., 180 days or 150 days), comments FDA in the report. The report includes tables showing the percentage of 505(q) petitions received during FYs 2008-2015, and the outcomes for the 167 petitions that have been resolved under FDC Act § 505(q) as of September 30, 2015.
Most of FDA’s 505(q) petition decisions – about 68% of them – have been denials. Often, these denials are without comment (see, e.g., here). According to FDA, “[t]here is no evidence that in enacting section 505(q) of the FD&C Act, Congress intended to bypass the application review process or to lessen the procedural rights of an ANDA or NDA applicant by requiring that the Agency make decisions that constitute final Agency action regarding the approvability of certain aspects of pending applications on a piecemeal basis outside of the process established under the FD&C Act and FDA regulations.”
As to 505(q) petitioning trends and FDA concerns, although the Agency pared down comments that appeared in previous reports, the bottom line in the FY 2015 Report is still the same. FDA says that “[i]t is difficult to determine whether section 505(q) is discouraging the filing of citizen petitions aimed at blocking generic or biosimilar competition. . . . There are no clear trends in the data over time.” But FDA’s primary concern – and one expressed over and over in previous reports – remains resources:
The Agency continues to be concerned that section 505(q) may not be 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.
Two specific concerns identified in previous reports are absent from the FY 2015 Report. Specifically, in the FY 2014 Report, FDA included the following comments:
- 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.
- 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.
Although these two concerns are not specifically identified in the FY 2015 Report, that’s not to say they are no longer concerns for FDA. (After all, serial petitioning still happens today, and FDA still has not used FDC Act § 505(q)(l)(E) to deny a petition). Both concerns appear in the FY 2015 Report in spirit as they come down to issues concerning a strain on Agency resources and FDA’s view that FDC Act § 505(q) has not discouraged petitioning.