This bill increases transparency requirements for how the Food and Drug Administration (FDA) manages over-the-counter drug monograph activities—the regulatory pathway for common OTC medications like pain relievers and cold medicines. Starting in fiscal year 2026, the FDA must publish detailed annual reports showing how many drug requests it processes by type, average processing timelines, and post-market safety monitoring efforts. The bill also requires the FDA to publicly release detailed minutes from industry negotiation meetings within 30 days, including substantive proposals and disagreements discussed. Additionally, the Government Accountability Office must complete a supply chain assessment of OTC monograph drugs within two years to evaluate data collection practices, FDA coordination with other agencies, and any additional authorities needed to maintain a stable supply. The legislation affects pharmaceutical manufacturers, contract manufacturers, and the FDA, with no new direct funding specified but with reporting obligations beginning in 2026.
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