3 in 1 Guidance Issued by FDA Covering Formal Dispute Resolution, Administrative Hearings and Consolidated Proceedings for OTC Monograph Drugs

July 4, 2023By Deborah L. Livornese

On June 23, 2023, FDA issued a draft guidance for industry – Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act (the Monograph FDR Guidance) – to fulfill another commitment agreed to in support of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act)(see our blog posts here, here and here about the CARES Act and OTC monograph reform).   Under the OTC Monograph User Fee Program commitment letter, FDA committed to modify existing guidance on formal dispute resolution (FDR) process and to issue guidance on consolidated proceedings for appeals.  Rather than modify the existing FDR guidance and issue separate guidance on consolidated proceedings, FDA has issued a single draft guidance covering both topics. The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process.  This is the third topic included in the new draft guidance.

Formal Dispute Resolution

The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences.  After FDA issues a final order under Section 505G of the Food, Drug, and Cosmetic Act, requestors who will be subject to the final order and sponsors of OTC monograph drugs that will be subject to the final order are eligible to request formal dispute resolution.  The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order.  A proposed order or an interim order is not an appropriate subject for an FDR.  Additionally, meeting minutes and other communications of advice that are not final orders are not appropriate subjects of an FDR because those materials typically make recommendations or give advice to which the sponsor or requestor is not bound (even though they may in some cases justifiably feel that not following the recommendation would be unlikely to lead to success).  Like the Existing FDR Guidance, the new draft guidance also clarifies that an FDR for an OTC final order must be based only on the same information that was relied upon to make the original decision and that new information or new analyses of previously reviewed data should not be included in the FDR.

Unlike the Existing FDR Guidance, however, the new draft guidance does not provide that a meeting with the decision maker can be requested, though it appears that FDA may decide on its own to have such a meeting.  This significant opportunity under the Existing FDR Guidance is not offered for monograph FDRs.  Another difference that may prove challenging for those seeking an FDR is that the new draft guidance includes quite short deadlines for submission of the FDR:  within 45 days of issuance of the final order for the first level of appeal and within 30 days of a prior decision for the next level of appeal.  While FDA provides a list of the information that needs to be included in the FDR, and this information can easily be put together in that time frame, 45 or 30 days does not allow much time for those seeking FDR to fully digest the decision being appealed and develop a meaningful analysis in response – a critical element of any effective FDR request under the Existing FDR Guidance.

The timelines for FDA’s response to an FDR follow those in the Existing FDR Guidance.  Ordinarily, the decision will be issued within 30 days from receipt of the request.  If, however, the deciding official requires additional information from the party submitting the request or from internal or external experts, or decides that a meeting with the requesting party is needed, an interim response will be issued within 30 days from receipt of the request, and the decision will then be issued within 30 days of FDA’s receipt of the needed information or the meeting.

The Monograph FDR Guidance also explains that, except to the extent public disclosure of information submitted to FDA is prohibited, the Agency generally intends to make information submitted to FDA in the context of FDR available to the public. This could include the FDR request and information submitted to FDA in support thereof.  Information submitted in connection with an FDR will remain confidential if (1) the information pertains to pharmaceutical quality information, unless the information is necessary to establish standards under which a drug is generally recognized as safe and effective or GRASE, or (2) the information is of the type contained in raw datasets.

Administrative Hearings

If the FDR process up to the Director of CDER is completed, eligible requestors and sponsors that participated in each stage of the FDR may request an administrative hearing not later than 30 days after the final FDR decision is issued.

FDA will not provide an opportunity for a hearing if the final order relates to certain drugs that were classified in Category III for safety or effectiveness in the preamble to the proposed rule that established the most recent tentative final monograph (TFM) if no human or nonhuman studies on the safety or effectiveness of the drug have been submitted to the administrative record since the most recent TFM was issued.

FDA may deny a request for a hearing if the request does not identify the existence of a “genuine and substantial question of material fact.”  In making its determination, FDA may consider only information and data that are based on “relevant and reliable scientific principles and methodologies”.

A hearing for a final order is not a formal, trial-type, evidentiary hearing.  The hearing will generally be public, but FDA may close all or part of the hearing to prevent disclosure of information FDA has held as confidential in the administrative record.  The presiding officer will not be an employee of CDER or have been previously involved in the development of the administrative order at issue.

Consolidated Proceedings

One of the challenges unique to the monograph system that the CARES provisions applicable to dispute resolution sought to address is the potential for a decision on a final order to affect multiple parties.  Consequently, proceedings may be consolidated on FDA’s initiative or upon request.

If more than one request for an FDR or hearing is submitted concerning the same final order, FDA may consolidate the requests and direct that a single proceeding be conducted.  Although all consolidated parties may participate in the FDR or hearing, the number of individuals from each party able to attend the consolidated proceedings in person may be limited because of facility and space limitations. FDA will determine the total number of individuals who can attend the consolidated proceedings in person.

Additionally, eligible requestors or sponsors may submit a joint request for an FDR or hearing with respect to the same final order.  In that case, a single point of contact must be designated by those requesting consolidation.  If a participant in a consolidated proceeding decides they no longer want to participate, they may withdraw and the proceeding may continue with the remaining eligible requestors or sponsors.

It may be a while before anyone seeks to utilize the processes covered by the draft guidance, but it is another commitment under OTC monograph reform checked off FDA’s to-do list.