Are You Ready for OTC Drug Reform? The 180 Day Deadline is Fast-Approaching

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States.¹  We previously described these reforms in an article titled, It is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform.² As the first significant update to the OTC regulatory scheme since FDA established the OTC Drug Review process in 1972, it is not surprising that the changes have resulted in a number of questions from clients regarding how to ensure compliance with FDA’s new OTC regulatory regime.³

This article serves as a reminder of a few key dates for some of the upcoming changes as the agency overhauls its OTC drug review process.

Category II Drugs

Under the OTC Drug Review process, FDA classified ingredients into Category I, II, or III. Category II ingredients are those that FDA considered to be not generally recognized as safe and effective or to have an unacceptable indication. Pursuant to the CARES Act, all Category II drugs are deemed to be “new drugs.” Therefore, a new drug application must be submitted for a Category II drug within 180 days of enactment of the CARES Act on March 27, 2020 (approximately September 23, 2020). Any manufacturer of a product containing a Category II ingredient should be aware of this requirement and ensure timely submission of a new drug application.

The limited exception to this requirement is if FDA determines it is the interest of the public health to extend the period during which the drug may be marketed without an approval. Otherwise, manufacturers must file a new drug application for their Category II drugs. To date, FDA has not made any determination to extend the period for any drug products containing a Category II ingredient.  With only a few weeks left before these products must be off the market, this may leave some companies in the same limbo that they have been operating under for the last four decades.

OTC Monograph Facility Fees

Under the CARES Act, FDA will collect an OTC Monograph Facility Fee starting with fiscal year 2021 (FDA’s fiscal year 2021 runs from October 1, 2020-September 30, 2021).   The CARES Act required FDA to establish the facility fees by the second Monday in May, and the fees were due on the later of the first business day of July 2020, or 45 calendar days after publication of a Federal Register Notice.  However, the Federal Register Notice has not been published, and it is yet to be seen when the facility fee will be due for fiscal year 2021.  This is likely due to the fact that the CARES Act also states that the fees “shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations acts.”  Congress has yet to pass any appropriations that would authorize FDA to collect the OTC User Fees.   With fiscal year 2021 just around the corner, we do not expect that FDA will publish a Federal Register Notice on this issue until Fall 2020 at the earliest.

For subsequent fiscal years after 2021, the facility fees will be due on the later of the first business day of June, or the first business day after the enactment of an appropriations act providing for the collection and obligation of fees for the year.

OMOR (OTC Monograph Order Requests)

The CARES Act also created an OTC Monograph Order Requests (“OMOR”) process, which refers to a request for FDA to issue an administrative order under section 505G of the Federal Food, Drug and Cosmetic Act to classify an OTC drug ingredient. While the agency may accept such requests now, we are still waiting for guidance from FDA on what should be included in an OMOR.  Because the CARES Act did not set specific deadlines for FDA to issue said guidance, it is unclear how the agency would handle an OMOR if received today, particularly since FDA has not collected the necessary user fees to hire reviewers or any other necessary staff.

Registration and Listing

Another important FDA requirement to keep in mind is the drug registration and listing requirement. It may become even more important for OTC drug manufacturers to ensure an accurate and up-to-date registration and product listing in the event that FDA decides to include the number of products a manufacturer has listed with FDA as part of the calculation for the facility fee amount. Therefore, reviewing and cleaning up any outdated listings that may include products that are no longer marketed will become an important step in the OTC marketing process, as the facility fee may depend on how many active listings a manufacturer has in FDA’s database.

[1] See “FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation,” available at https://www.fda.gov/news-events/press-announcements/fda-signing-covid-19-emergency-relief-bill-including-landmark-over-counter-drug-reform-and-user-fee

[2] The article is available at the following: 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/.

[3] For some frequently asked Questions & Answers, please see our Q&A available at https://www.agg.com/news-insights/publications/qa-the-cares-act-and-otc-drug-reform-in-2020/.