Monday, August 25, 2014

HELP Committee Unveils Draft Proposing Sunscreen, OTC Review Timelines

HELP Committee Unveils Draft Proposing Sunscreen, OTC Review Timelines-insidehealthpolicy: Top lawmakers on the Senate health committee Friday (Aug. 22) unveiled a discussion draft bill that would streamline FDA's evaluation of sunscreen ingredients by establishing a timeline for reviews and also push the agency to establish timelines for other over-the-counter ingredients. The draft builds on the House-passed Sunscreen Innovation Act by adding OTC reforms. Sens. Tom Harkin (D-IA), Lamar Alexander (R-TN), Jack Reed (D-RI) and Johnny Isakson (R-GA) back the draft bill and are seeking public comment. The Senate discussion draft would clear a backlog of sunscreen ingredient submissions within eight months and require FDA review new submissions within an 11-month timeframe, which is included in the House-passed bill.