The Over-the-Counter Scientific/Regulatory Paradigm

Abstract

A dialogue-driven, case-by-case, weight-of-the-evidence approach utilizing specific switch criteria and encompassing the application of evolving science and technology continues to be the foundational underpinning of the pivotal benefit-risk assessment determining over-the-counter (OTC)ness of an ingredient. As an OTC scientific/regulatory paradigm, it is robust and should be preserved, especially in any guidances the Food and Drug Administration (FDA) may issue about 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:

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The OTC Review rulemaking as the foundation of the OTC scientific/regulatory paradigm

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How OTC new drug approval in the 1990s did not change the OTC paradigm per se, but rather allowed the OTC paradigm to be fulfilled as it was always envisioned to be fulfilled by the creators of the OTC Review and the OTC scientific/regulatory paradigm definers (the OTC panels)

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The FDA's recent negative guidance on OTC drugs for hypercholesterolemia, which challenges the current robust OTC scientific/regulatory paradigm

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A specific recommendation to FDA on how to express the agency's current thinking on specific OTC candidates in guidance documents, in order to be consistent with the current OTC scientific/regulatory paradigm and thus help ensure that OTC research and development of novel OTC drugs can flourish in the future.