The FDA has issued a final Guidance for Industry titled Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act (here). It provides guidance for sponsors and others on dispute resolution and hearing processes with the Center for Drug Evaluation and Research (CDER) once the Agency has issued a final administrative action (Final Order). This guidance finalizes the draft guidance of the same title issued on June 23, 2023. Section 505G of the FD&C Act speaks to the issuance of OTC final administrative orders under the Over-The-Counter Monograph Drug User Fee Program (OMUFA).

The Federal Register pre-publication notice (here) states that, after consideration of the comments publicly submitted to the docket announcing the draft guidance, there are two significant changes in the final guidance:

    1. Clarifying that the recommendations in the guidance are limited to Formal Dispute Resolution (FDR) in accordance with sections 505G(b)(2)(A)(iv)(III) and 505G(b)(4)(D)(iii) of the FD&C Act and to hearings in accordance with section 505G(b)(3) of the FD&C Act; and
    2. Removing language implying that new information could be submitted outside of, but at the same time or during, the FDR to avoid any suggestion that an eligible requestor or sponsor submitting a request for FDR should actively engage with other entities within the FDA or pursue other regulatory or legal pathways on the same matter at the same time.

 

“For administrative efficiency, rather than amend the existing FDR guidance to include FDR procedures for Final Orders and issue a separate guidance for consolidated proceedings for appeals, FDA is issuing this single guidance. This guidance addresses the process for resolving scientific and/or medical disputes of Final Orders, including FDR, administrative hearings, and consolidated proceedings. FDA has incorporated recommendations from the existing FDR guidance as appropriate.”