OTC Monograph Reform Added To Draft Senate Stimulus Compromise

An updated draft of the Senate’s COVID-19 stimulus bill, floated Tuesday (March 24), includes over-the-counter drug monograph legislation that would establish an FDA user fee program for OTC drugs, give innovative OTC drugs 18 months of exclusivity and change the way FDA responds to OTC drug safety. The draft is the latest version of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748), which has been stalled due to bipartisan disagreement. Unlike previous versions of the CARES Act,...