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User Fees

March 16, 2017 | Daily News

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.

March 15, 2017 | Daily News

House Energy & Commerce health subcommittee Chairman Michael Burgess (R-TX) doubled down Wednesday (March 15) on his criticism that FDA is moving too slowly to institute the biosimilar pathway.

March 02, 2017 | Daily News

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.

February 27, 2017 | Daily News

An alliance of drug companies and research advocacy groups is calling for Congress to appropriate $2.8 billion for FDA in fiscal 2018 -- a $78 million increase from fiscal 2016.

February 23, 2017 | Daily News

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.

February 09, 2017 | Daily News

HHS personnel slots listed as exempt from President Donald Trump's federal hiring freeze appear to apply to some FDA drug center generic drug user fee hires, according to an internal HHS memo and an FDA drug center list of job opportunities.

February 07, 2017 | Daily News

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.

January 30, 2017 | Daily News

House Energy & Commerce Democrats on Monday (Jan. 30) asked President Donald Trump to provide details on whether FDA user fee programs will be exempted from the federal hiring the White House announced Jan. 23.

January 25, 2017 | Daily News

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).

January 23, 2017 | Daily News

President Donald Trump signed a presidential memorandum freezing federal government hiring Monday (Jan. 23), potentially damaging FDA's efforts to fill 1,000 vacancies at the agency if FDA jobs are not exempted under the memo's clause exempting personnel needed for public safety or those deemed by the Office of Personnel Management chief as “otherwise necessary.”

December 29, 2016 | Daily News

FDA’s efforts to fill 1,000 vacancies at the agency, boosted by provisions in the 21st 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.

December 20, 2016 | Daily News

Over a dozen Senate Democrats urged President-elect Donald Trump to tackle high prescription drug costs and suggested in a letter Tuesday (Dec. 20) that upcoming FDA user fee bills offer an “ample opportunity” for him to do so.

November 14, 2016 | Daily News

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.

November 08, 2016 | Daily News

The National Center for Health Research is criticizing FDA for having fewer meetings with patients and public health advocates during the biosimilar user fee negotiations than during other use fee negotiations, and said this lack of engagement makes it difficult for the group to judge whether the new user fee agreement is adequate.

October 21, 2016 | Daily News

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).

September 30, 2016 | Daily News

The controversial pediatric review voucher program will survive another three months following President Barack Obama's signature of a short-term stopgap bill Friday (Sept. 30).

September 23, 2016 | Daily News

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.

September 16, 2016 | Daily News

FDA unveiled goals for the second iteration of the biosimilar user fee program Friday (Sept. 16) that include a call for more communication between applicants and the FDA review team to minimize the number of review cycles needed for approval.

August 26, 2016 | Daily News

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.

August 22, 2016 | Daily News

FDA and the medical device industry appear to have smoothed out a point of contention in negotiations for the user fee reauthorization by including plans for a pilot to assess the effectiveness of real-world evidence to support premarket activities, according to statements by the agency and the industry groups outlining a tentative agreement on user fee goals.