OTC Monographed Products Face Scrutiny


  • August 26, 2014

By Carrie Rabe

The recently released briefing materials for the upcoming FDA advisory committee meeting on healthcare antiseptics should serve as a warning for those anxious for the FDA to finalize the still open OTC monographs. These briefing materials clearly indicate that the FDA intends to evaluate safety and efficacy of OTC products according to current standards. This includes not only those products originally classified by the OTC review panels as having insufficient evidence of safety and efficacy (Class III products) but also those designated previously as Generally Recognized as Safe and Effective (Class I or GRASE).

In the briefing materials for the healthcare antiseptics advisory committee meeting, the FDA proposes that, at a minimum, data on the dermal penetration of antiseptics in human users, nonclinical safety (e.g., pharmacokinetics, reproductive and developmental toxicity, dermal carcinogenicity), hormonal effects, and microbial resistance development potential are needed to establish healthcare antiseptic safety. Not surprisingly, large data gaps were identified by the FDA for all of the healthcare antiseptics covered by the monograph. None of the eleven healthcare ingredients the FDA reviewed were found to have adequate data on dermal penetration and systemic exposure in humans and all but two of the ingredients were found to have inadequate dermal carcinogenicity or bacterial resistance data. More products were deemed to have adequate animal pharmacokinetics, oral carcinogenicity, developmental and reproductive toxicity, and hormonal effects data. However, none had complete safety data; even those originally designated as GRASE and used widely for more than 4 decades.

It will be interesting to see how the Advisory Committee will address the FDA’s questions on the data standards needed to establish product safety and how these should impact the Class I (GRASE) OTC products. It is certain that manufacturers of other classes of OTC products for whom monographs are not yet final will be following the proceedings as they prepare for FDA attention to turn their way.

Carrie Rabe is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us