The IRA And US FDA: How Will Agency View Any Drug Development Changes?
Executive Summary
US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.
You may also be interested in...
Medicare Drug Pricing Casts A Cloud Over J.P. Morgan’s Opening Day
Inflation Reduction Act means that industry ‘will have to adjust’ to new market realities, especially for small molecule drugs.
An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation
Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.
Yet Another Bad Day For PBMs On Capitol Hill
Democrats and Republicans in the US Congress are not getting along on most topics these days. But when it comes to criticizing the pharmacy benefit management sector, they see eye-to-eye.