“A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.”
No CRS summary available for this bill.
This section revises citizen petition procedures under section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)—which limits FDA responses to certain petitions to prevent delays in approving abbreviated new drug applications (ANDAs under 505(j)), 505(b)(2) applications, or biosimilar biological product applications (under 351(k) of the Public Health Service Act)—to promote timely generic and biosimilar market entry. Specifically, the section (1) in paragraph (1)(A)(i) adds 21 C.F.R. §10.31 to the list of regulations under which petitions are presumptively submitted to delay approval; (2) in paragraph (1)(E) revises the process and factors for determining if a petition's primary purpose is delay—including timeliness relative to when information was known, serial or duplicative petitions, proximity to generic approval dates, lack of supporting data, requests for more onerous standards than for the reference product, and the petitioner's history of delay tactics (with FDA to issue guidance on additional factors)—and strikes former subparagraph (F), redesignates (G)-(I) as (F)-(H), and updates cross-references; and (3) in paragraph (2) requires petitions to precede related civil actions against FDA and be filed within 180 days after the petitioner knew the relevant information, adjusts FDA response timelines by removing the fixed 150-day period, and mandates court dismissal of noncompliant civil actions (without prejudice for failure to file a petition first or before FDA's final response; with prejudice for untimeliness).