Transparency, Communication Needed In OTC Monograph System – PCPC
This article was originally published in The Rose Sheet
While FDA’s OTC drug monograph system is an “appropriate and rational framework” for regulating cosmetic-drug products, greater transparency and more regular communication with industry are needed, according to the Personal Care Products Council’s Elizabeth Anderson, executive VP-legal and general counsel, who offered comments March 25 at a public hearing on potential improvements to the process.
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Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.
The Independent Cosmetic Manufacturers and Distributors recognizes the need for improvement but urged FDA to maintain ingredient approval under its OTC drug monograph system at the agency’s March 26 hearing; NSF provides an updated timeline for its natural personal-care standard; more news in brief.
A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under a pair of deadlines of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand-wash products by Dec. 16, with a final monograph due Sept. 15, 2016.