User Fees

The Biden administration’s fiscal 2022 budget released Friday (May 28) proposes giving FDA $3.6 billion in budget authority, which FDA says would provide an 8% increase over fiscal 2021 enacted levels, though FDA watchers assert it would actually add up to an 11% increase.

FDA announced Thursday (March 25) that it has raised facility fees for its over-the-counter monograph user fee program to make up for the lack of revenue from non-traditional hand sanitizer manufacturers that temporarily entered the market provide sanitizer during the COVID-19 pandemic and were then carved out of the user fee program by the Trump administration.

FDA will increase its generic drug user fee application and drug master file fees in fiscal 2021 while reducing overall generic program and facility fees across the board, the agency announced Friday (July 31).

FDA announced Wednesday (July 29) that it will decrease application costs for its prescription drug user fee program in fiscal 2021, but it will increase overall program fees by about $11,000 over fiscal 2020 levels, for a total of about $336,000.

The brand drug lobby and patient groups say the next iteration of prescription drug user fee legislation should expand use of decentralized clinical trials and digital health technologies that can collect data remotely.

FDA anticipates it may not be able to continue meeting its prescription drug and biosimilars user fee goal dates, as many of its staff members are focusing on COVID-19 activities, the agency says in guidance published Tuesday (May 26).

The Trump administration wants to move the Center for Tobacco Products out of FDA and establish a new HHS agency to regulate tobacco -- a proposal opposed by major public health organizations and the head of the House Appropriations Committee.

Heading into 2020, third-party medical device servicers will focus on two key issues: extending right-to-repair laws to medical devices, and addressing cybersecurity on older medical devices, industry representatives told Inside Health Policy.

The U.S. District Court of the District of Columbia ruled on Friday (Dec. 6) that FDA cannot regulate Genus Medical Technologies’ barium sulfate contrast agent as a drug because it qualifies as a medical device under the statute.