President Signs FDA User Fee Renewal Bill

A bill reauthorizing the FDA’s user fee agreements for the next five years became law Aug.18 when President Trump signed it.

The bill, given near-unanimous approval by Congress, was the culmination of two years of work and negotiations with private industry.  It ignored Trump’s calls to have industry fund 100 percent of user fee-related activities, freeing up taxpayer dollars allotted to the agency. The White House issued an official statement of policy following House passage in mid-July, but Senate leaders said requests to renegotiate the terms of the agreements had come “too late”.

The program is expected to bring in $1.42 billion in fees, about a quarter of the agency’s budget, over the next fiscal year — funding the individual programs that cover inspections and reviews of drugs, generics, biologics and biosimilars and medical devices, as well as more than a third of the agency’s approximately 14,000 employees — and includes provisions for hiring 230 additional staff in the next five years.