Prescription-to-over-the-Counter Switch Criteria
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
PRESCRIPTION-TO-OVER-THE-COUNTER SWITCH CRITERIA R. WILLIAMSOLLER,PHD Senior Vice President and Director of Science & Technology, Consumer Healthcare Products Association, Washington, District of Columbia
This paper traces the evolution of prescription-to-over-the-counter (OTC) switch criteria and assesses the impact of new developments in this and related areas, as a means to create a conceptual framework for considering the future of prescription-to-OTC switch. Over the past two decades, switch criteria have evolved from the foundational definitions of safety, effectiveness, and labeling in the OTC Review through the pharmacological interpretations of OTCness in Peck’s Principles, to the modern day focus in DeLapk Principles on the consumer as the focal point for studying endpoints of self-care. Today’s switch criteria represent a solid regulatory/scientific foundation for the next evolution of OTC drugs: to treat chronic conditions and diseases, which are not being adequately treated with current health care options. Further dialogue on the potential for OTC access to enhance collaborative self-care should be actively considered. Key Words: Prescription; OTC; Switch criteria; Self-care
OVER THE YEARS, as drug sponsors have sought to expand the OTC market with novel self-care therapeutics, interest has centered on defining the essential criteria for switching drugs from prescription-to-OTC status. The reason for this is simple. Sponsor research and development programs are more efficient if the Food and Drug Administration’s (FDA’s)decision making process is transparent and predictable. When the frontier of OTCness is pushed in a new way, however, the current switch criteria are reassessed and refined to ensure that the agency’s premarketing benefithisk judgment is appropriately sensitive to account for new methods of intended drug use by consumers. Often, it has been the industry that has pushed the agency Reprint address: R. William Soller, Senior Vice President and Director of Science & Technology, Consumer Healthcare Products Association, 1150 Connecticut Ave. NW, Washington, DC 20036. E-mail: wsoller@ chpa-info.org.
to articulate its current thinking on criteria for prescription-to-OTC switch, as a means to stage future discussions on novel switches. This paper traces the evolution of prescription-to-OTC switch criteria and assesses the impact of new developments in this and related areas, as a means to create a conceptual framework for considering the future of prescription-to-OTC switch. “OTCness means the widespread availability of safe and effective nonprescription medicines for responsible self-care by the consumer according to label directions, pursuant to the applicable laws, regulations, and voluntary industry codes affecting manufacturing, packaging, labeling, distribution, and sales of quality products and the advertising of those products in all media” (1). This definition remains unchanged by the evolving switch criteria, princ
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