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User Fees

Friday, 24 March 2017

FDA drug center head Janet Woodcock told Inside Health Policy that her recent statement on the impact of proposed changes to the Pediatric Research Equity Act (PREA), which appeared to go against previous HHS statements, was directed solely at a subset of pediatric orphan diseases.

Wednesday, 22 March 2017

The House is unlikely to honor President Donald Trump’s budget request to double user fees, a House GOP aide told Inside Health Policy Wednesday (March 22), emphasizing that key committees have already began considering the user fee commitments agreed upon between FDA and industry.

Wednesday, 22 March 2017

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.

Tuesday, 21 March 2017

There are less than 20 pending generic applications for drugs currently without competition, FDA drug center chief Janet Woodcock told Senate health committee lawmakers Wednesday -- prompting a key Democrat to call for more sweeping action on drug pricing.

Tuesday, 21 March 2017

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.

Friday, 17 March 2017

All 11 Senate health committee Democrats are asking Chair Lamar Alexander (R-TN) to essentially put off Tuesday's FDA user fee hearing and instead hold a hearing on the House GOP's health care bill.

Thursday, 16 March 2017

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.

Thursday, 16 March 2017

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.

Thursday, 16 March 2017

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.

Wednesday, 15 March 2017

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.

Thursday, 02 March 2017

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.

Monday, 27 February 2017

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.

Thursday, 23 February 2017

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.

Thursday, 09 February 2017

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.

Tuesday, 07 February 2017

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.

Monday, 30 January 2017

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.

Wednesday, 25 January 2017

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).

Monday, 23 January 2017

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.”

Thursday, 29 December 2016

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.

Tuesday, 20 December 2016

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.