Posted: 11 Feb 2019 07:19 PM PST
FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017. The Report, which is required by FDC Act § 505(q)(3), gives us the picture and numbers from FDA’s experience during Fiscal Year 2017 (“FY 2017”) with citizen petitions subject to FDC Act § 505(q). The Report provides updated numbers for FY 2017 and largely repeats both FDA’s concerns about petitioning expressed in previous reports (see our previous posts here, here, here, here, here, here, here, here, and here) and the trends the Agency has been seeing in petitioning. It does not mention recent actions taken by the Agency to try to curb the alleged use of citizen petitions to “game” the system (perhaps, as described below, because the actions occurred in FY 2018).
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 issued a final rule in November 2016.
Most recently, in October 2018, FDA issued a revised draft guidance that describes factors FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic application (see our previous post here). 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. FDA’s actions and words continue to build a firmer basis and procedure for someday doing so.
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.
FDC Act § 505(q)(3) requires that each 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 Tenth Annual Report to Congress that:
During the FY 2017 reporting period, the Agency approved 763 ANDAs, 57 505(b)(2) applications, and 3 biosimilar biological product applications. No approvals for biosimilar biological product applications or ANDAs were delayed because of a 505(q) petition in this reporting period. The approval of one 505(b)(2) application was delayed because of one 505(q) petition. During FY 2017, FDA received 25 505(q) petitions.
The delayed 505(b)(2) approval was delayed by 28 days. “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,” says FDA in the report (in what is now boilerplate language). FDA does not identify by name or application number the particular approval delayed.
As to the number of 505(q) citizen petitions submitted in FY 2017, the Report says that the Agency received 25 petitions, which is up from 19 in FY 2016. The outcomes of FDA’s 210 petition responses from FY 2008 through FY 2017 are shown in a table included in the report. Approximately 67% (141 petitions) of the 210 petition decisions have been denials, while another approximately 25% (53 petitions) have been denied in part and granted in part. Only about 5% (10 petitions) have been granted. Two petitions were granted in FY 2017, which is the first year in which FDA has granted a 505(q) petition since FY 2013. We think both of those petition decisions concerned the availability of New Chemical Entity exclusivity (see here and here). The remaining 6 petitions (about 3%) were voluntarily withdrawn by the petitioner. (You can view all relevant petitions on the FDA Law Blog Citizen Petition Tracker.)
As to 505(q) petitioning trends and FDA concerns, the Agency continues a trend of paring down comments that appeared in previous reports. That being said, FDA’s bottom line in the FY 2017 Report maintains the tone adopted in the FY 2016 report and concludes with the statement, “Accordingly, as part of the Drug Competition Action Plan, FDA is reviewing what actions can be taken to address these issues.”
FDA Commissioner Dr. Scott Gottlieb announced the Agency’s Drug Competition Action Plan (“DCAP”) in Spring 2017 (here). The intent of the DCAP is to encourage generic drug development and competition. Since the creation of the DCAP, FDA has taken several steps to implement that plan, including holding a public meeting in July 2017, issuing REMS guidance in May 2018 (here), and issuing last week a Manual of Policies and Procedures on internal FDA responsibilities and procedures for developing a single, shared system REMS or a separate REMS (here). Given FDA’s statement that the Agency is reviewing what actions can be taken under the DCAP to address citizen petition concerns, more new citizen petition initiatives may be on the horizon.
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 issued a final rule in November 2016.
Most recently, in October 2018, FDA issued a revised draft guidance that describes factors FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic application (see our previous post here). 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. FDA’s actions and words continue to build a firmer basis and procedure for someday doing so.
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.
FDC Act § 505(q)(3) requires that each 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 Tenth Annual Report to Congress that:
During the FY 2017 reporting period, the Agency approved 763 ANDAs, 57 505(b)(2) applications, and 3 biosimilar biological product applications. No approvals for biosimilar biological product applications or ANDAs were delayed because of a 505(q) petition in this reporting period. The approval of one 505(b)(2) application was delayed because of one 505(q) petition. During FY 2017, FDA received 25 505(q) petitions.
The delayed 505(b)(2) approval was delayed by 28 days. “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,” says FDA in the report (in what is now boilerplate language). FDA does not identify by name or application number the particular approval delayed.
As to the number of 505(q) citizen petitions submitted in FY 2017, the Report says that the Agency received 25 petitions, which is up from 19 in FY 2016. The outcomes of FDA’s 210 petition responses from FY 2008 through FY 2017 are shown in a table included in the report. Approximately 67% (141 petitions) of the 210 petition decisions have been denials, while another approximately 25% (53 petitions) have been denied in part and granted in part. Only about 5% (10 petitions) have been granted. Two petitions were granted in FY 2017, which is the first year in which FDA has granted a 505(q) petition since FY 2013. We think both of those petition decisions concerned the availability of New Chemical Entity exclusivity (see here and here). The remaining 6 petitions (about 3%) were voluntarily withdrawn by the petitioner. (You can view all relevant petitions on the FDA Law Blog Citizen Petition Tracker.)
As to 505(q) petitioning trends and FDA concerns, the Agency continues a trend of paring down comments that appeared in previous reports. That being said, FDA’s bottom line in the FY 2017 Report maintains the tone adopted in the FY 2016 report and concludes with the statement, “Accordingly, as part of the Drug Competition Action Plan, FDA is reviewing what actions can be taken to address these issues.”
FDA Commissioner Dr. Scott Gottlieb announced the Agency’s Drug Competition Action Plan (“DCAP”) in Spring 2017 (here). The intent of the DCAP is to encourage generic drug development and competition. Since the creation of the DCAP, FDA has taken several steps to implement that plan, including holding a public meeting in July 2017, issuing REMS guidance in May 2018 (here), and issuing last week a Manual of Policies and Procedures on internal FDA responsibilities and procedures for developing a single, shared system REMS or a separate REMS (here). Given FDA’s statement that the Agency is reviewing what actions can be taken under the DCAP to address citizen petition concerns, more new citizen petition initiatives may be on the horizon.
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