User Fees

House lawmakers, FDA officials and industry stakeholders all praised the success of the agency’s breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Agreement (PDUFA) will bring important resources to the breakthrough effort.

A week after the president took stakeholders by surprise by proposing industry fully pay for FDA premarket reviews by doubling up on user fees, the White House plan was barely mentioned as Senate health committee Chairman Lamar Alexander (R-TN) launched hearings Tuesday (March 21) on user fee pacts penned by the Obama administration and industry.

President Donald Trump's budget blueprint sparked concerns among multiple stakeholders and legislators Thursday (March 16) for putting stable appropriations funding and already-negotiated FDA user fee agreements at risk.

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

Key House Energy & Commerce lawmakers expressed concern during a user fee reauthorization hearing Thursday (March 2) over FDA’s 9 percent first-cycle approval rate for generics, as well as the progress made in implementing the biosimilars pathway -- despite assurances from industry and FDA that the programs are improving the agency’s approval numbers.

Amid concerns from House Energy & Commerce lawmakers that the Trump administration's federal firing freeze could negatively impact FDA's user fee commitments, the committee has scheduled a March 2 hearing on reauthorization of the generic and biosimilar user fee programs.

The White House Office of Management and Budget received a request detailing which jobs HSS wants exempted from President Donald Trump's federal hiring freeze, an OMB spokesperson told Inside Health Policy Tuesday (Feb. 7), but details on which, if any, FDA jobs were requested for exemption remain unclear.

Public health jobs, such as those at FDA, could certainly fall under the public safety exemption in President Donald Trump's presidential memorandum hiring freeze, a White House spokesperson told Inside Health Policy Wednesday (Jan. 25).

FDA’s efforts to fill 1,000 vacancies at the agency, boosted by provisions in the 21^st Century Cures Act, could be jeopardized by President-elect Donald Trump’s proposed federal government hiring freeze, warned Steven Grossman, deputy executive director of the Alliance for a Stronger FDA.