ACCESS Through OTC Innovation Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to apply the least burdensome appropriate means when evaluating requests to determine if over-the-counter (OTC) monograph drugs are generally recognized as safe and effective. Specifically, for administrative order requests concerning OTC drugs, the Secretary must ensure that the methods for supporting such requests are as efficient and straightforward as possible. If existing published reports are insufficient to support a request, the bill mandates that the Secretary meet with the requestor, upon a reasonable written request, to provide recommendations on the types of evidence needed. These recommendations may include guidance on the potential design and size of studies required to demonstrate that the drug is safe and effective. The Secretary is also required to prepare and make available meeting minutes and incorporate written recommendations into the administrative record, without altering the fundamental criteria for drug safety and effectiveness.