The Over-The-Counter Scientific/ Regulatory Paradigm
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THE OVER-THE-COUNTER SCIENTIFIC/ REGULATORY PARADIGM R. WILLIAM SOLLER, PHD Senior Vice President and Director of Science and Technology, Consumer Healthcare Products Association, Washington. District of Columbia
A dialogue-driven, cnse-by-case. weight-of-the-evidence approach utilizing specific switch criteriu and encompassing the application of evolving science and technology continues to be the foundational underpinning of the pivotal benefit-risk assessment determining over-the-counrer (0TC)nessof nn ingredient. As an OTC scientifidregu1a:or-y paradigm. it is robust and should be preserved, especially in any guidances the Food and Drug Administration (FDA)may issue cibou: the “OTC-ability*’of specific therapeutic agents. In developing this premise in the context of the pivotal benefit-risk assessment, it is important to consider: The OTC Review rulemaking as the foundarion of the OTC scien:ific/regulatoy paradigm, How OTC new drug upproval in the 1990s did not change the O X paradigm per se, but rather nllowed the OTC paradigm to be fulfilled as it M’US always envisioned to be fulfilled by the creators ofthe OTC Review and the OTC scientific/regulrton? paradigm definers (the OTC panels), The FDA> recent negarive guidance on OTC drugs f o r hvpercholesterolemia, which challenges the current robust OTC .scientific/regulatoy purudi,qm. A specjfic recommendation to FDA on how to express the agencyS current thinking on specific OTC candidates in guidance documents. in order to be consistent with the curren: OTC scientific/re~~ulato~i paradigm and thus help ensure that OTC research and development of novel OTC drug.s can flourish in the future. Key Words: Over-the-counter; OTCness; Scientifidregulatory paradigm
THE OTC REVIEW AND FORMATION OF THE MODERN OTCNESS PARADIGM
prescription 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). The pivotal decision affecting whether or not an ingredient will achieve widespread availability is the OTC benefitrisk assessment. While the OTC benefit-risk assessment has never been explicitly defined, it has been characterized through the statutory mandates ~~
OTCNESS IS DEFINED AS ‘‘ . . . the widespread availability of safe and effective non-
Presented at the DIA Workshop ”OTCness: Changing the Paradigm,” September 1617, 1998. Washington. District of Columbia. Reprint address: R. William Soller, PhD, Senior Vice President and Director of Science and Technology, Consumer Healthcare Products Association. I150 Connecticut Ave. NW, Washington. DC 20036.
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H. William Soller
for OTCness, the regulatory standards for OTCness, and the decisions of the OTC panels, which were, in
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