|Footnotes for this article are available at the end of this page.
On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter (OTC) Monograph Reform and provide guidance on the Administrative Order process, with a particular emphasis on “safety orders.”1 Prior to the CARES Act, FDA had to engage in a multi-step public rulemaking process in order to establish or revise an OTC drug monograph. This process was not only burdensome but, more important, it made it challenging for the agency to be able to quickly implement changes to an OTC drug monograph to address safety issues.
As discussed in a previous Bulletin, the CARES Act established a new Administrative Order Process that allows FDA, among other things, to more efficiently make changes (e.g., add, remove, or change Generally Recognized as Safe and Effective (GRASE) conditions for an OTC Monograph) to an OTC drug monograph.2 This Administrative Order process can be initiated by industry and FDA. In addition, FDA now also has an expedited Administrative Order process.
Under the expedited Administrative Order process, the FDA or the U.S. Department of Health and Human Services (HHS) can initiate an expedited procedure and issue an interim final administrative order under two circumstances:
- Imminent hazard to public health – The HHS Secretary determines that “a drug, class of drugs, or combination of drugs . . . . poses an imminent hazard to the public health.” The HHS Secretary cannot delegate the authority to issue an imminent hazard final order.
- Safety labeling change – FDA determines that “a change in the labeling of a drug, class of drugs, or combination of drugs . . . . is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with the use of the drug.”
When using the expedited Administrative Order process, FDA or HHS will issue an interim Final Administrative order before the public has an opportunity to comment. The interim Administrative order will go into effect on the date specified by the agency. After the public comment period is over, FDA will then issue a Final Administrative order. This is different from the standard Administrative Order Process, where FDA will first publish a proposed order for public comment and then issue the final Administrative Order after the comments have been evaluated. An Administrative Order issued under the standard process will become effective once the time for requesting a judicial review has expired.3
The agency described the FDA-initiated Administrative Order process as follows:
Step 1 – Notify Sponsors – The agency plans to make a “reasonable effort” to informally notify sponsors of covered listed drugs no later than 2 business days before the issuance of a proposed order (or 48 hours before the issuance of an interim final order).4
Step 2 – Issue Proposed Order – FDA will issue a proposed order in the Federal Register (or interim final order under expedited procedure) along with its reasons.
Step 3 – Notice – FDA publishes a notice of availability of the proposed order (or the interim final order) in the Federal Register.
Step 4 – Public Comment – FDA provides for a public comment of at least 45 calendar days for public comment.
Step 5 – Issue Order – FDA issues the final order along with its reasons.
FDA plans to create a public, web-based portal called “OTC Monographs@FDA,” to allow the public to view proposed and final Administrative Orders and supporting documents and to submit comments (including data) to proposed Administrative Orders. The portal is expected to be fully operational in 2022. The agency will also publish an annual “nonbinding” listing of OTC monograph issues that it intends to address in the coming three years, including safety labeling changes. This will include any requests for data, the format for submissions, and the date by which the data needs to be submitted. According to the agency, in most cases, industry will have approximately 180 days to submit data, unless the agency determines that a shorter period of time is necessary. Comments and data submitted to the agency will be made public. FDA plans to publish the first “nonbinding” list by October 1, 2021, and plans to update this list “no less frequently than annually.”
- OTC Monograph Drug Reform will take more than a few years to implement given some of the timeframes for the publication of the nonbinding list of OTC monographs and for the OTC Monographs@ portal to be fully operational. This could be further delayed the longer the agency has to continue putting its resources to address pandemic-related issues.
- With FDA and HHS’ new ability to issue these interim final orders to address safety issues that could affect entire product lines and categories, it is now more imperative for companies to closely monitor adverse events so that they are able to anticipate a potential action by FDA.
- At this point, there is no indication of how FDA will prioritize the list of OTC monograph issues. Given all the issues with hand sanitizer products and the high usage of these products during the pandemic, it would make sense that the antimicrobial drugs monograph would be closer to the top of the list for the agency.
- During the presentation, FDA noted that it will no longer use regulations.gov to collect comments on OTC drug monograph-related publications. This makes it more imperative that OTC Monographs@FDA is an easy-to-use platform, which is not always the case for some of the submission portals available from the Center for Drug Evaluation and Research.
 See Webinar titled, OTC Monograph Reform in the CARES Act: Safety Orders, available at https://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-reform-cares-act-safety-orders-01272021-01272021
 See AGG Bulletin titled, “It Is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform”, available at https://www.agg.com/news-insights/publications/it-is-not-all-about-the-coronavirus-the-cares-act-brings-long-awaited-over-the-counter-otc-monograph-reform/.
 A request for judicial review must be filed no later than 60 calendar days after the date on which the Final Administrative Order is published. See Section 505G(b) of the Federal Food, Drug and Cosmetic Act.
 Covered listed drugs are the OTC drugs that are listed with FDA per 21 C.F.R. Part 207 and will be affected by the proposed Administrative Order.