Bill > HR6868

This bill, titled the "ACCESS Through OTC Innovation Act," aims to streamline the process for approving over-the-counter (OTC) drugs by directing the Secretary of Health and Human Services to use the "least burdensome appropriate means" when evaluating requests for administrative orders. This means that when a company requests approval for an OTC drug that is generally recognized as safe and effective, the Secretary should consider the simplest and most practical methods to support that request. If published reports are not enough to prove a drug is safe and effective, the Secretary must meet with the company that made the request to offer guidance on what kind of evidence, including potential study designs and sizes, would be needed. The Secretary will also be required to document these meetings by preparing and sharing minutes with the company, and these records will become part of the official administrative record, ensuring transparency and clarity in the approval process without changing the fundamental standards for determining if a drug is safe and effective or if a request is complete enough for review.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/6868/all-info