APhA responds to FDA’s draft guidance on advancing access to nonprescription drugs

Pharmacists should be included in discussions about new approaches to OTC access

In July, FDA issued draft guidance, “Innovative Approaches for Nonprescription Drug Products,” to outline ways of making more products available over the counter by enhancing information and providing tools to patients that will help them appropriately choose nonprescription drug products.

In a statement accompanying the release of the draft guidance, FDA Commissioner Scott Gottlieb, MD, outlined approaches for disseminating information to patients such as apps, online questionnaires, and changes in the drug facts label on packaging. However, the draft guidance makes no mention of pharmacists or other health care providers. Shortly after the release of the guidance, APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, sent a letter to FDA urging the agency to work with APhA and pharmacists as FDA develops and advances the regulatory framework for nonprescription medications.  

In the letter, Menighan said, “While APhA supports your agency’s efforts to increase patients’ access to safe and affordable medications, we were disappointed the roles of pharmacists and other health care professions were not mentioned in the recently released guidance.”

Menighan went on to state, “Across all settings, patients rely on pharmacists to learn about safe medication use. Consequently, APhA believes pharmacists’ services and expertise need to be included among the approaches drug sponsors consider when identifying additional conditions necessary for safe and effective use of a nonprescription drug product.”

APhA had plans to provide further feedback on the draft guidance before public comments close on September 17.