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.

Robert Califf testified during a Senate Health, Education, Labor and Pensions Committee confirmation hearing in Washington, DC, on 14 December, 2021
Robert Califf testified during a Senate Health, Education, Labor and Pensions Committee confirmation hearing in Washington, DC, on 14 December, 2021 • Source: Alamy

Now that Bob Califf has again been appointed to helm the US Food and Drug Administration, the medtech industry is looking to him for leadership as they negotiate a new but delayed user fee deal with the agency.The FDA and medtech groups AdvaMed, the Medical Device Manufacturers Association (MDMA), and the Medical Imaging and Technologies Alliance (MITA) have been struggling to agree on a new Medical Device User Fee Amendment (MDUFA V) deal. As Califf takes the reins at the agency, some are hoping he’ll be able to help get a deal across the finish line – or at least sell it to lawmakers when it’s ready.

MITA executive director Patrick Hope congratulated Califf and laid out a number of priorities that he hopes the commissioner will...

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