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# Stimulus Bill Includes New OTC Drug User Fees
- URL: https://www.fdaweb.com/stimulus-bill-includes-new-otc-drug-user-fees/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:08:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146431

The coronavirus-related economic stimulus[ legislation](https://www.appropriations.senate.gov/imo/media/doc/FINAL%20FINAL%20CARES%20ACT.pdf?ref=fdaweb.com) that is quickly moving to become law includes language to allow FDA to create a new user fee program for over-the-counter (OTC) drugs. The Coronavirus Aid, Relief, and Economic Security (CARES) Act would authorize such fees for OTC monograph drug reviews effective in fiscal year 2021\. Fees will also fund the hiring of additional staff members to ensure there is adequate agency oversight of OTC drugs.

According to a Foley & Lardner [analysis](https://www.foley.com/en/insights/publications/2020/03/senate-passes-coronavirus-cares-act?ref=fdaweb.com), the measure “(**1**) reforms the regulatory process for OTC drug approvals permitting the FDA more flexibility to make changes administratively, rather than through the time-consuming full notice and comment rulemaking process; and (**2**) incentivizes pharmaceutical companies to research and manufacture innovative drug products by providing an 18-month market-exclusivity period to reward investments for new OTC drugs.”  

The bill also clarifies that an OTC drug which does not comply with monograph requirements would be considered misbranded, Foley & Lardner says. It clarifies that nothing in the CARES Act will apply to drugs previously excluded by FDA from OTC drug reviews.