Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act [“FDC Act”].”¹ Section 505G and the guidance apply to over-the-counter (“OTC”) drugs that are sold according to an applicable “monograph” and do not require an approved marketing application.

We will highlight some of the key points in the draft and offer our own recommendations.

Background

We will not review in detail the OTC monograph process or the Coronavirus Aid, Relief, and Economic Security Act of 2020 (the “CARES Act”). However, to provide context, we will summarize those parts of the CARES Act that we believe explain how FDA arrived at this point.

• The CARES Act added section 505G to the FDC Act (21 U.S.C. § 355g), which revised the framework for the regulation of OTC monograph drugs.
  • OTC monograph drugs may be marketed without an approved drug application if they meet the section 505G requirements and other applicable rules (not discussed here).
• The CARES Act also added section 744M (21 U.S.C. § 379j-72), which allows FDA to assess and collect user fees for OTC monograph-related activities.
• FDA may issue orders (proposed and final) that add, remove, or change generally recognized as safe and effective (“GRASE”) conditions for OTC drug monograph. If a product is GRASE, it is not a “new drug,” thereby not requiring FDA approval.
  • FDA or a sponsor can initiate the order process (a requestor can start the process by submitting an OTC monograph order request (“OMOR”) for certain drugs, classes of drugs, or combinations of drugs).
• After FDA issues a final order, it must allow requestors of drugs that will be subject to the order the opportunity for Formal Dispute Resolution (“FDR”), which can go up to the level of the Center for Drug Evaluation and Research (“CDER”) Director.
• FDR begins at the management level in the CDER chain of command, above the level where the decision was made. Similarly, if FDA issues a final order in an expedited procedure (not discussed here), the same opportunity and process for FDR remains.
• If the FDR process does not yield the results the company wants, it may request a hearing.
  • The agency can consolidate multiple requests covered by the same final order.
• The Over-the-Counter Monograph User Fee Program Performance Goals and Procedures documents (the “OMUFA” commitment letter) provides FDA and industry timelines for FDR. The commitment letter does not specify times for
  • The OMUFA commitment letter also explains that FDA will issue guidance on its views regarding best practices for consolidated proceedings for appeals, and FDA has included that consolidated appeals guidance as part of this draft guidance.[2]
• FDA notes FDR is appropriate for scientific and/or medical disputes related to a determination in a final order whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs is determined to be: (1) not a prescription drug, and (2) GRASE.
• The issuance of a proposed order or an interim final order is not a final order. As such, a company may not request FDR at that time.
• Meeting minutes and other FDA correspondence (e.g., general advice matters) are not final orders.
• A company that submits an FDR request should not contact others within FDA or pursue other regulatory or legal pathways on the same matter at the same time.
• An eligible requestor must submit an FDR request within 45 calendar days of the issuance of the final order.
  • For subsequent levels of appeal, the request must occur within 30 calendar days of the prior decision.
• Any hearings for the final order issued in an expedited procedure must occur not later than 12 months after the date on which the final order is issued.
  • FDA must specify in an interim final order if shorter periods for requesting FDR are necessary to meet the 12-month timeline for completing a hearing.
• An FDR request should not include new information.
  • New or updated analyses of previously reviewed data is considered new information.
• The OTC monograph order processes are “generally public.”
  • Except where public disclosure of information submitted to FDA is prohibited.
• FDA will keep confidential information if: (1) the information concerns pharmaceutical quality information, unless the information is necessary to establish standards under which a drug is GRASE; or (2) the information is of the type contained in raw datasets.
• Only the eligible requestor or sponsor may be present at the meeting with FDA. Any meeting held during FDR is not open to the public.
• FDR strongly encourages a requestor or sponsor to contact CDER and provide advance notice of the intent to submit a request for FDR.
• An FDR request should go through the CDER NextGen Portal.[3]
  • FDA advises that an electronic copy of the request should also go to the CDER Formal Dispute Resolution Project Manager.
• A sponsor should provide sufficient information, so FDA understands the scientific and/or medical dispute and to allow the deciding official how to proceed.
• Each request should include the following:
  • Identification of the submission as FORMAL DISPUTE RESOLUTION REQUEST in bold, uppercase letters.
  • The order identification (“ID”) number.
  • The OTC monograph ID number and OTC monograph title, if applicable.
  • The determination(s) in the final order that are the subject(s) of dispute, including the identification of specific OTC monograph provisions, if any, that are implicated.
  • A “brief but comprehensive statement of each issue to be resolved,” including:
    • a description of the scientific and/or medical dispute to be resolved;
    • a summary of relevant regulatory history, including any prior stage of FDR related to the same scientific and/or medical dispute, if applicable; and
    • a statement of the eligible requestor’s or sponsor’s proposed possible solutions and/or outcomes.
  • A statement identifying the division and/or office that issued the final order and, if applicable, the deciding official on any prior stage of FDR related to the same scientific and/or medical dispute.
  • A list of documents previously submitted as part of the OMOR or public comments (including information and data) submitted during the public comment period for the proposed order that are necessary to resolve the matter.
  • A statement that no new information has been submitted in support of the request for FDR and, if applicable, that the last deciding official received and had the opportunity to review all of the material now being relied upon for FDR.
  • The name, title, and contact information (mailing address, email address, telephone number, fax number) for the eligible requestor’s or sponsor’s contact for the FDR.
• If the FDR request is accepted, it will go to the appropriate CDER management level.
  • The requestor will receive a letter identifying the deciding official, the due date for response, and the date of any meeting, if applicable.
• If an FDR request is not accepted, FDA will respond with the reasons for rejection.
• The deciding official handling the FDR request will send a written decision.
  • A rejection should include the reasons, and, if possible, offer other options.
• The deciding official may provide an interim response (e.g., a request to clarify information in the request for FDR or a request for a meeting with the eligible sponsor) before making a decision on the appeal.
  • This interim response should explain why an interim response is being issued, rather than a final decision.
• The deciding official should complete review and provide an interim response or a decision on the appeal within 30 calendar days from receipt of a request.
  • The deciding official should respond within the 30-day window in writing or by telephone.
  • If the response is by telephone, the deciding official should follow up with a written communication within 14 calendar days of the verbal response.
• If the deciding official requires additional clarifying information or input from other persons knowledgeable about the matter, the official should send an interim response identifying the additional information or input needed.
  • Should be made within 30 calendar days of receipt of the appeal.
• If the deciding official believes a meeting is needed before making a decision, the official should send a request for a meeting within 30 calendar days from receipt of the request.
  • The deciding official should provide an interim response or a decision on the request within 30 calendar days from the meeting date.
• If the deciding official cannot complete the review and provide either an interim response or a decision within 30 calendar days, CDER should notify the sponsor, explain the reasons for the delay, and provide the anticipated timeline for completing the review.
• A company can appeal the matter if the FDR is denied at one management level through the CDER chain of command, up to the level of the CDER Director.
  • For each appeal, a new request for FDR should be submitted to the next management level and the aforementioned process and timelines apply.
• FDA decides on a presiding officer for a final order hearing.
  • The presiding officer will not be an employee of CDER or have been previously involved in the development of the administrative order at issue or proceedings relating to that administrative order.
• If the matter proceeds up to the level of CDER Director, an eligible requestor or sponsor may request a hearing concerning a final order if not satisfied (with limited exception, not discussed here).
• A sponsor must submit the request for a hearing within 30 calendar days after receiving notice of the final decision of the FDR procedure.
• FDA must complete any hearings for a final order issued in an expedited procedure within 12 months after the date on which the final order is issued.
• Like the FDR request, a hearing request should be submitted through the CDER NextGen Portal.
  • Sponsors should contact the Office of New Drugs in CDER before submitting the hearing request.
• The request for a hearing must be based solely on information in the administrative record.
• FDA recommends the hearing request include:
  • Identification of the submission as OTC MONOGRAPH FINAL ORDER ADMINISTRATIVE HEARING REQUEST in bold, uppercase letters.
  • The order ID number.
  • The OTC monograph ID number and OTC monograph title, if applicable.
  • The determination(s) in the final order that that are the subject(s) of dispute, including the identification of specific OTC monograph provisions, if any, that are implicated.
  • A brief but comprehensive statement of each issue to be resolved, including the following:
    • a description of what the requestor or sponsor contends is a genuine and substantial question of material fact justifying a hearing;
    • a list of references to information in the administrative record that supports the hearing request, including submission dates, so the documents can be readily located;
  • a statement that no new information has been submitted in support of the request for a hearing; and
  • the name, title, and contact information (mailing address, email address, telephone number, fax number) for the eligible requestor’s or sponsor’s contact for the request for a hearing.
• FDA will conduct a primary review of a hearing request to determine if it is timely and if the requestor or sponsor is eligible to request a hearing.
• FDA may deny a hearing request “if the request does not identify the existence of a genuine and substantial question of material fact.”
• A hearing for a final order is generally public. FDA may close all or part of the hearing if FDA considers there to be confidential information may be discussed.
• Parties to a hearing have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties.

AGG Observations

• This guidance offers more clarity on FDR and the hearing process.
• FDA makes it clear that no new information may be included in the request, and the requestor must follow the internal chain of command.
• While companies don’t want to have to proceed with FDR (and neither does FDA), this FDR guidance provides useful information.
• If you would like to submit a comment on this draft guidance or review any comments submitted thus far, the docket is open, with comments due by August 22, 2023.⁴

[1] The draft guidance is available here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g. We also thought of the Decemberists’ 2011 song, “This Is Why We Fight,” but we preferred the more pacifist “friends” theme.

[2] We will not be outlining this section of the guidance regarding consolidated proceedings on appeal, in this Bulletin.

[3] CDER’s NextGen Portal is available at: https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=876592757_1614020952133&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp.

[4] The docket is available here: https://www.regulations.gov/docket/FDA-2023-D-2204.