Senators Optimistic As Sunscreen Bill Heads For HELP Committee Markup
This article was originally published in The Rose Sheet
Executive Summary
Ahead of a Sept. 17 committee markup of the Senate’s Sunscreen Innovation Act, bill sponsors and stakeholders held a briefing on Capitol Hill to generate support for the legislation, which has already passed in the House. The bill, S. 2141, has 15 co-sponsors and is expected to advance through committee to the Senate floor.
You may also be interested in...
Merck’s Keytruda Opens Door, But Combination Trials Could Unlock Efficacy
FDA’s approval of Merck’s anti-PD-1 drug pembrolizumab in melanoma marks a major milestone for oncology and industry’s immune checkpoint efforts. But with an overall response rate in labeling of 24%, there’s still room for improvement with combinations and use in earlier lines of therapy.
All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill
Senate HELP committee leaders release a draft bill for discussion that builds on the Sunscreen Innovation Act and its proposed deadlines for FDA review of sunscreen TEA applications, adding provisions that would require FDA to set “reasonable” review deadlines for all OTC ingredient TEAs.
NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval
FDA’s Nonprescription Drugs Advisory Committee will meet Sept. 4-5 to discuss the scope of safety testing necessary for OTC sunscreen ingredients, following FDA’s rejection this year of three time-and-extent applications to add new sunscreen actives to the OTC monograph. The committee’s input will be valuable if FDA faces deadlines for sunscreen TEA decisions under the Sunscreen Innovation Act, which passed the House July 29.