All OTC Ingredient TEAs Get Review Deadlines In Senate Draft Bill
This article was originally published in The Rose Sheet
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.
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The Senate approves an amended version of the Sunscreen Innovation Act by unanimous consent, with a view toward speeding FDA reviews for all OTC ingredient TEAs. The House version addresses only sunscreen TEAs, and reconciliation of the two chambers’ bills likely will have to wait for the lame duck session.
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.
CHPA comments on the Senate HELP Committee’s draft legislation that would require FDA to establish review deadlines for TEAs. The trade group says it is “neutral” about the proposal, but offers to help the committee with “more comprehensive reviews of OTC approvals.”