Industry Looks To Califf’s Leadership As It Negotiates User Fee Deal, Fights Pandemic
After the US Senate barely greenlit Robert Califf to again helm the US FDA, industry sources say they look forward to him taking an active role in ensuring the next user fee deal is successful.
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The US FDA and industry have scheduled five meetings over the next two weeks to negotiate a device user fee deal. Both sides are under pressure from lawmakers to come to an agreement.
Robert Califf’s nomination to be the next US FDA commissioner squeaked out of the Senate health committee, but a significant number of Republicans are against his confirmation over the agency’s recent decisions on abortion drugs.
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.