Today, the Consumer Healthcare Products Association (CHPA) issued the following statement upon submitting comments to the Food and Drug Administration (FDA) regarding its draft guidance titled, “Innovative Approaches for Nonprescription Drug Products.”
“CHPA is committed to empowering consumer self-care by expanding choice and availability of safe, effective, and affordable over-the-counter (OTC) medicines. CHPA therefore supports increased flexibility with OTC drug product approval, especially in Rx-to-OTC switch programs. FDA’s draft guidance acknowledges that certain types of medicines only available by prescription today may one day be ‘switched’ to nonprescription, OTC use if manufacturers can identify novel ways to help consumers correctly self-select and safely use them.
“While this guidance will be helpful for sponsors to develop innovative approaches specific to their Rx-to-OTC switch program, we encourage FDA to release the anticipated proposed regulations as soon as possible so that all stakeholders can understand the broader scope of the framework being considered. Additionally, technology in the consumer health space is rapidly evolving, therefore, it’s our hope that the parameters ultimately put in place not only allow for the types of innovation mentioned in the draft guidance, but also support the adoption and flexibility of future innovations.”
