On May 7, APhA submitted comments to FDA on the concept of certain OTC products being available through conditions of safe use (OTC+ for short). This served as follow-up to my testimony to FDA in March.

Our letter answers the many questions on which FDA was seeking feedback. We again focused on the opportunity to improve access and public health, use pharmacists, communicate and collaborate with our medical colleagues, and ultimately do what is best for the patient. While we know some medical groups and patient advocates are concerned or otherwise opposed to the concept, we view this as a great opportunity to help FDA plan for the future. It is important to remember that if there is an OTC+ in the future, it will be manufacturers who are responsible for pursuing approval of their products in this space.

It is our understanding that FDA intends to focus next steps on the regulatory process using its existing authority rather than try to seek a specific legislative fix. We are okay with this. We will continue to advocate in support of the concept knowing that many of the uncertainties can be answered as discussions move forward.