Expanding Pharmaceutical Access Via Over the Counter Drugs

This commentary addresses the recent U.S. Food & Drug Administration (FDA) proposed rule to expand access to nonprescription drugs through additional conditions of nonprescription use (ACNU). It surveys the various pathways to market for pharmaceutical products, noting the distinct requirements for over-the-counter (OTC) products differentiating them from prescription products. It subsequently reviews the ACNU proposed rule, weighing its potential benefits against possible limitations. With a view towards the future, the ACNU proposed rule is acknowledged as part of a longstanding tradition to expand drug channels in a risk-stratified fashion with increasing clinical oversight to address in tandem increasing consumer risks. Finally, the proposed rule also serves as a potential prelude for a future behind the counter drug pathway. It is time to think differently about treating chronic disease. According to the Centers for Disease Control and Prevention, over 120 million Americans suffer from inadequately treated hypertension or diabetes. The latter alone contributes to over $327 billion in direct medical costs and lost productivity [1], a figure compounded by an insufficient pool of physicians and advanced practitioners to guide treatment. Building upon existing longstanding efforts to support access to nonprescription drugs, separately both direct-to-consumer sales and pharmacist-mediated medication use offer unique levers to increase the number of drug channels thus expanding access to pharmaceuticals. This viewpoint reviews the current paths to market for pharmaceutical products, evaluates the U.S. Food and Drug Administration’s (FDA) recent proposed rule expanding nonprescription over-the-counter (OTC) drugs through Additional Condition for Nonprescription Use (ACNU) [2], and explores the potential for a future behind-the-counter (BTC) pathway to expand basic medication access for a variety of societal needs such as the treatment of chronic diseases. Read More.