The bill would require the Food and Drug Administration (FDA) to include more information in its annual reports on over-the-counter (OTC) monograph drugs. Starting with fiscal year 2026, reports would cover progress on drug order requests, processing times, safety work, and facility registrations and fee payments. The FDA would also publish detailed minutes of fee negotiation meetings within 30 days. Within two years of enactment, the Government Accountability Office would report to Congress on the OTC monograph drug supply chain.
The bill does not set out new requirements for consumers. It would make more information about FDA activities and fee negotiations available to the public and call for a review of the OTC drug supply chain.
The text does not state the cost of carrying out these requirements or change the amount of user fees. It would require reporting whether certain facilities paid assessed fees. No publicly available information about costs is provided.
No publicly available information.
No publicly available information.