FDA clarifies process for disputing OTC orders in final guidance

The US Food and Drug Administration (FDA) has finalized a guidance on how to conduct formal dispute resolutions (FDR) and administrative hearings to resolve scientific and/or medical disputes with sponsors of over-the-counter (OTC) drugs. The agency updated the draft version of the guidance to clarify limitations of the FDR process and ensure that requesters don’t use multiple venues to address the same order.

On 22 December, FDA finalized the guidance that updates Section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C) as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, which states that regulators must allow OTC requesters and sponsors a chance to dispute their final orders. The procedures in the guidance were agreed upon between FDA and industry as part of the Over-the-Counter Monograph User Fee Act (OMUFA) negotiations.

“This guidance describes the FDR procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a Final Order,” said FDA. “This guidance also outlines the procedures for an administrative hearing related to a Final Order.

“Finally, as required by section 505G(l)(4) of the FD&C Act, this guidance describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes,” the agency added.

Under Section 505G, FDA has the authority to issue proposed and final orders that add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drugs, and either the agency or the requester can initiate the order process. If the requester has participated in every stage of the order process before it is finalized and is dissatisfied with the agency’s decision, they or the sponsor is eligible to request a hearing to change the order.

The section also stated that if more than one request for an FDR or hearing is submitted on the same final order, the agency can consolidate the requests and conduct a single proceeding. With that in mind, FDA noted that, instead of issuing a separate guidance on consolidated proceedings for appeals and updating its current FDR guidance with procedures for addressing final orders, it decided to issue the new final guidance to consolidate both topics and avoid administrative inefficiency.

FDA received several comments from industry that it said have been accommodated in the final version. More specifically, the agency stated that it has tried to clarify that the recommendations in the guidance are limited to specific parts of Section 505G. It also noted that it has removed language that could imply that any new information submitted in the FDR could be used to simultaneously engage with other parts of FDA or to pursue other regulatory or legal pathways on the same topic.

One of the main changes in the final guidance is the addition and clarification of how FDA plans to conduct a preliminary review of a request for FDR. The agency said it will conduct a preliminary review of the request within 30 calendar days to determine whether the request was submitted within the statutory period and whether the requester is eligible to file the request. As part of the preliminary review, the agency will also determine whether the request should be consolidated with other requests regarding the same final order.

FDA also added timeline expectations in the final guidance when deciding to accept or reject a request for an FDR. The agency said the Formal Dispute Resolution Project Manager (FDRPM) assigned by the Center for Drug Evaluation and Research (CDER) will send a letter within 30 days of the FDR requesting period expiring to the requester, whether their request has been accepted or not.

"If the request for FDR is accepted, the acknowledgment letter will identify the deciding official, the date by which FDA will provide its response, and, if applicable, the date of any meeting requested by the deciding official," said FDA. "If more than one request for FDR with respect to the same Final Order is accepted for review and FDA determines that consolidation of the requests is appropriate, FDA will provide notice of consolidation to each requestor or sponsor of such consolidated requests.

"If the eligible requestor’s or sponsor’s request for FDR is accepted, the FDRPM will forward the appeal to the appropriate CDER management level, as established under the CDER chain of command," the agency added.

Final guidance

FDA clarifies process for disputing OTC orders in final guidance

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