ACCESS Through OTC Innovation Act

Summary

Requires the Food and Drug Administration to use the "least burdensome" appropriate means when reviewing certain requests to issue administrative orders that a nonprescription (OTC) monograph drug is "generally recognized as safe and effective." When published reports are insufficient, the FDA must meet with a requester (if the requester asks in writing), provide recommendations on evidence and study design, record meeting minutes, and include any recommendations in the administrative record. The change explicitly does not alter existing requirements for completeness of submissions or the statutory standard for whether a drug is generally recognized as safe and effective.

• Requires FDA to use the "least burdensome appropriate means" when reviewing certain administrative order requests that an OTC monograph drug is GRASE.
• Allows a requester to obtain a written meeting with FDA when published reports are insufficient and the requester reasonably asks in writing.
• Mandates that FDA produce meeting minutes and include recommendations and a meeting summary in the administrative record.
• Does not change the statutory GRASE standard or the criteria for determining whether a submission is sufficiently complete for substantive review.
• Focuses on procedural changes to FDA review and engagement, not on altering substantive safety or effectiveness requirements.
• Aims to provide clearer guidance on types of evidence and study design to support requests.
• Likely to reduce unnecessary data burdens for some requesters while preserving the agency's final decision authority.
• Increases FDA's administrative obligations to document meetings and recommendations when the conditions are met.