OTC Monograph System Needs Transparency, Communication – PCPC
This article was originally published in The Tan 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 Personal Care Products Council executive Elizabeth Anderson.
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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.
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 one deadline 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 by Sept. 15, 2016.
Sunscreens containing zinc oxide and titanium dioxide nanoparticles rate relatively highly in the Environmental Working Group’s annual Sunscreen Guide, though the advocacy group says greater transparency is needed regarding products with nano-engineered ingredients.