“CHPA is pleased to see FDA’s long-awaited draft guidance on innovative approaches for greater consumer access to nonprescription medicines, and applauds FDA’s focus on patient safety as a top priority. FDA’s draft guidance acknowledges that certain types of medicines only available by prescription (Rx) today may one day be ‘switched’ to nonprescription, over-the-counter (OTC) use if manufacturers can identify novel ways to help consumers correctly self-select and safely use them.
“Considering advancements in digital health technology such a apps, new additional types of labeling, or other innovations as part of the new drug application (NDA) process for OTC medicines is a welcome modernization of this regulatory framework. For several years, manufacturers have been talking to FDA about using approaches like those outlined in the draft guidance to support Rx-to-OTC switches. CHPA is happy to see that the agency believes it has the authority to include and regulate innovative approaches as part of the OTC new drug application (NDA) approval process.
“With this guidance, and the proposed rule to follow, FDA and sponsors should be able to align on the specifics of research programs and, if the data provided are supportive, include innovative approaches as part of an approved switch application.
“We appreciate the opportunity to submit comments to FDA and look forward to seeing the final guidance.”