Shutdown: Will Drug Reviews Become ‘Emergencies’ When User Fee Money Runs Out?
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
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Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."