On Wednesday, the Food and Drug Administration (FDA) announced increased over the counter (OTC) monograph drug user fee rates for 2022. The fees are assessed on businesses involved in the manufacture of OTC monograph drugs.
Over the counter monograph drugs are a class of drugs that have been reviewed for safety and efficacy and are considered to be safe for consumer usage without the diagnostic review or oversight of a trained medical professional. These drugs are governed by the provisions of section 505G of the Food, Drugs and Cosmetics Act.
A drugmaker that seeks to have its drug classified as an OTC monograph was required to pay a $500,000 fee in fiscal year 2021, while such a request in 2022 costs $507,021.
The release explained that Section 744M of the Act, which was introduced as a part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), authorizes the FDA to assess and collect fees from businesses involved in the manufacture or processing of the finished dosage form of an OTC monograph drug, or any party requesting an OTC monograph administrative order from the FDA.
Businesses who registered with the FDA during the COVID-19 pandemic solely for the purposes of creating hand sanitizer are exempt from these fees under the CARES act.
The fees are graduated according to the types of processing involved in the manufacturing process, and are designated for the purposes of inspecting those facilities and for the administrative costs of administering the OTC program, as adjusted for inflation.
To see the full chart of costs and methodology for calculation, please view the announcement located here: https://public-inspection.federalregister.gov/2022-05542.pdf.
