President Donald Trump signed a bill reauthorizing the FDA’s user fee agreements for drugs and devices. The bill had received bipartisan support in the House and Senate prior to landing Trump’s signature.
The bill will fund a new digital health unit and allow the agency to tap into new data sources, according to FierceHealthcare.com, which noted that there was little fanfare from the White House after Trump had sought to increase user fees.
According to the FDA blog, the bill officially authorized the Medical Device User Fee Agreement (MDFUA), which establishes a central digital health unit within the Center for Devices and Radiological Health (CDRH).
Overall, FDARA reauthorizes:
- The Prescription Drug User Fee Act (PDUFA) for the fifth time;
- The Medical Device User Fee Amendments (MDUFA) for the third time;
- The Generic Drug User Fee Amendments (GDUFA) for the first time; and
- The Biosimilar User Fee Act (BsUFA) for the first time.
The existing bill was set to expire in October 2017, but the reauthorization means the FDA can continue to collect medical product user fees through fiscal year 2022.