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Califf Deftly Navigates Sunscreen Catechism In Confirmation Hearing

This article was originally published in The Rose Sheet

Executive Summary

FDA commissioner nominee Robert Califf emphasizes that adequate evidence is key to moving sunscreen TEAs through FDA’s evaluation process, addressing the issue during his Senate confirmation hearing. He also fielded questions about use of FDA rulemaking authority versus guidance and seemed to pass inspection regarding previous industry connections, though Democratic presidential candidate Bernie Sanders continues to have reservations.

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Gottlieb Recognizes OTC Monograph Woes During Confirmation Hearing

FDA commissioner nominee Scott Gottlieb agreed that the OTC drug monographs constitute “a system that is in need of modernization” during his April 5 confirmation hearing before the Senate HELP Committee. HELP Democrats tested the FDA commissioner nominee’s willingness to “stand up to the administration” and probed potential conflicts of interest.

PASS Reacts To Sunscreen TEA Denials: Has FDA ‘Moved The Goal Post’?

The Sunscreen Innovation Act may have served to clear FDA’s queue of pending sunscreen TEAs, but with denials across the board due to insufficient data, the Public Access to Sunscreens coalition questions the tenability of FDA’s standards and approach to review. The denial of L’Oreal’s TEA for ecamsule, an ingredient already available OTC through a new drug approval, only reinforces PASS’ view that FDA is resistant to working outside of the NDA pathway.

Cosmetics Industry Awaits FDA’s Allergen List While Working To Inform GMP Rulemaking

The Independent Beauty Association does not yet have insight into what ingredients will be listed in the US FDA’s proposed rulemaking for cosmetic allergen labeling – due by 29 June – but is optimistic the agency will consult industry when it comes to setting the compliance timeline. Meanwhile, industry stakeholders are pushing for international harmonization in the agency’s cosmetic GMPs rulemaking.

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