FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message

By Deborah L. Livornese — 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…

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