March 25, 2021
The following quote is attributed to Patrizia Cavazzoni, M.D., Acting Director of the FDA's Center for Drug Evaluation and Research:
“Over-the-counter (OTC) drugs have long provided an efficient, low-cost way for Americans to manage everyday health needs, and they play an increasingly vital role in our health care system. The passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020 established a user fee program to support the modernization, under the CARES Act, of how many OTC drugs are regulated by FDA, including changes that will facilitate innovation and make it easier for the FDA to respond to safety issues when they emerge. As we continue the agency’s efforts on this front, today we are republishing fee rates under this OTC Monograph Drug User Fee Program (OMUFA)— an important step in implementing the OTC monograph reform provisions under the CARES Act.
Following FDA's issuance of the initial OMUFA user fee notice, the FDA determined that certain hand sanitizer producers—those which registered with FDA during the COVID-19 Public Health Emergency (PHE) solely to produce hand sanitizer products during the COVID-19 PHE—would not be required to pay OMUFA facility fees. We appreciate and understand the concerns raised by these manufacturers, especially the small businesses that stepped up during the COVID-19 pandemic to help meet the increasing demand for alcohol-based hand sanitizers.
Hand sanitizer manufacturers not subject to the OMUFA facility fees are still subject to other applicable FDA requirements. The FDA will continue to use its regulatory compliance and enforcement tools to protect consumers, including from potentially dangerous or sub-potent hand sanitizers.
Due to this change in fee assessment, we acknowledge that firms subject to the OMUFA facility fees will see an increase in the fiscal year 2021 facility fees, compared to fees shown in the withdrawn fee notice. However, by supporting OTC monograph reform efforts, these fees will aid in improving the efficiency, timeliness, and predictability of the review process for OTC monograph drugs. Better pathways for innovation, helping ensure applicable quality standards are met, and the ability to rapidly address safety issues benefit all parties. The FDA remains committed to working with industry and stakeholders to ensure a smooth, transparent and productive implementation of this important public health program."
- Today, the U.S. Food and Drug Administration announced the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. The CARES Act, enacted in March 2020, amended the FD&C Act to direct FDA to assess and collect annual facility fees from owners of qualifying OTC monograph drug facilities (in addition to fees for OTC monograph order requests).
- The FDA first announced these fees in a Dec. 29, 2020, Federal Register Notice titled "Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021." The Dec. 29, 2020, Federal Register Notice has been withdrawn and is no longer valid, despite still being available on the Federal Register website. The Department of Health and Human Services (HHS) issued a new Federal Register Notice on Jan. 12, 2021, clarifying that “persons that entered into the over-the-counter drug industry for the first time in order to supply hand sanitizers during the COVID-19 Public Health Emergency are not persons subject to the facility fee the Secretary is authorized to collect under section 744M of the Food, Drug, and Cosmetic Act.”
- Accordingly, as stated in the Jan. 12, 2021, notice from HHS, the FDA will not assess facility fees on those companies that first entered the over-the-counter drug market on or after Jan. 27, 2020, solely to produce hand sanitizer products during the COVID-19 Public Health Emergency
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.