PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean
Executive Summary
Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard.
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User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Rep. Phil Gingrey, lead sponsor of the Generating Antibiotic Incentives Now Act, says industry still has questions about the proposed approval pathway for antibiotics treating life-threatening diseases, further clouding its prospects.
Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill
Reforms merit one sentence, which would end waiver caps for conflicts of interest, but it is unclear whether it will solve the problems patient groups and others have with the advisory committee selection process.