User Fees

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.

Conducting research on how to establish equivalence of complex drug products is among the five fiscal 2017 scientific priorities of FDA's generic drug office.

The next round of the generic drug user fee program will tie industry fees to approved abbreviated new drug applications as opposed to requiring industry to pay fees when an application is submitted regardless of whether it is approved, FDA said Friday (Oct. 21).

FDA reached a draft user fee pact with the generic drug industry that calls for a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.

FDA and the medical device industry have agreed that if Congress enacts legislation in fiscal year 2017 allowing the device center to increase pay for scientists and other professional positions, as proposed in the House-passed 21st Century Cures bill, they will craft a plan aimed at retaining key personnel currently funded in part by user fees, according to minutes of recent meetings.