NCPA submitted comments to FDA’s proposed rule, Nonprescription Drug Product With an Additional Condition for Nonprescription Use. According to the proposed rule, under an ACNU, a drug manufacturer must ensure that patients can appropriately self-select a medication. FDA states that under this proposed new class of drugs, patients can complete a questionnaire or view a video with assessments to confirm their understanding of the medication. In addition, drug manufacturers could also provide information to customers via in-pharmacy kiosks, apps, and online. Unfortunately, this proposed rule envisions such medication as being administered without the supervision of a health care practitioner, and it therefore excludes pharmacists. NCPA opposed FDA’s proposed ACNU class of drugs given our concerns with its safety, administrative burden, and payment implications. Instead, we supported greater prescriptive authority in lieu of this rule. In our comments, we also thanked FDA for holding a listening session on Nov. 15 with us and the American Pharmacists Association, American Society of Consultant Pharmacists, National Association of Chain Drug Stores, and National Alliance of State Pharmacy Associations to hear our concerns.
NCPA
