Increased FDA transparency on OTC drugs and supply chain
This Act mandates greater transparency from the Food and Drug Administration (FDA) regarding over-the-counter (OTC) monograph drugs. It requires the FDA to publish detailed annual reports on progress in meeting goals regarding OTC monograph order requests and post-market safety activities. Furthermore, the law ensures public access to minutes from negotiation meetings between the FDA and the industry and mandates a report assessing the supply chain of these drugs.
Key points
Progress Reporting: The FDA must publish annual reports including data on the number of OTC monograph orders issued and the average timeline for processing requests.
Drug Safety Monitoring: Reports will include information on FDA's post-market safety activities for OTC drugs, including the collection of adverse event information.
Public Negotiation Minutes: The FDA must make robust written minutes of negotiation meetings with the regulated industry publicly available within 30 days.
Supply Chain Assessment: The Comptroller General will submit a report assessing the stability of the OTC monograph drug supply chain and coordination to mitigate disruptions.
Introduced
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