OTC Drug Monograph Reform In The CARES Act

By Kalah Auchincloss

In March, Congress included in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) long-awaited reforms to the FDA’s regulation of OTC drugs. Consumers, industry, and others had argued for years that the FDA’s oversight of OTC drugs was antiquated and in need of an overhaul.

Provisions like those included in the CARES Act were discussed (but ultimately not included) as part of FDA-related legislation enacted in 2016 and had subsequently passed both the House and Senate in various forms over the last two years. The changes included in the CARES Act are intended to address challenges with the old system, allowing more nimble OTC oversight and potentially ushering in a new era of OTC safety and innovation.