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User Fees

September 10, 2013 | Health Exchange Alert

Administration officials were developing a proposal to pitch to unions that would involve the creation of two separate health insurance trusts, one of which would allow those eligible for ACA exchange subsidies to receive them, sources say, in response to concerns voiced by many unions and other groups that workers enrolled in existing multi-employer plans are ineligible for such subsidies. But unions indicated that the idea does not seem workable for a whole host of reasons, labor sources say.

June 18, 2013 | Daily News

A key Senate appropriator is working to protect FDA user fees from sequestration and has included language in a report accompanying the agency funding bill that highlights the issue.

June 10, 2013 | Daily News

FDA is focusing on the review of generic drug prior approval supplements for medications in shortage and has set up a new “attack team” to whittle down the supplement application backlog as it works to meet commitments agreed to under the Generic Drug User Fee Act, an agency official recently said.

May 24, 2013 | Daily News

The top Democrat on the House FDA funding panel is trying to identify ways to pay for a measure that would allow FDA to access $85 million in sequestered user fees before he introduces language that could be tacked onto an agency funding bill, according to a congressional source.

May 08, 2013 | Daily News

Pioneer and generic animal drug user fee legislation easily cleared the House Energy and Commerce Committee's health panel Wednesday (May 8) as lawmakers instead focused on debating separate drug traceability legislation, which was marked up in the same session.

May 03, 2013 | Daily News

FDA is in discussions with the White House Office of Management and Budget and congressional committees about gaining access to $85 million in sequestered industry fees, the agency's financial officials said, noting that the issue is starting to resonate on Capitol Hill.

April 26, 2013 | Daily News

House appropriators with jurisdiction over FDA debated reducing the impact of sequestration on the agency, as it has recently done for others, so that FDA could fulfill commitments it made to the drug and device industries during user fee negotiations last year.

April 18, 2013 | Daily News

The ranking Republican on the Senate appropriations subcommittee with jurisdiction over FDA raised the possibility of exempting agency user fees from sequester cuts during a hearing on Thursday (April 18), with FDA Commissioner Margaret Hamburg also expressing concern that sequestration of user fees could harm future negotiations with industry.

April 12, 2013 | Daily News

House Energy and Commerce members questioned FDA's top veterinary official and other experts about the connection between the use of animal antibiotics and growing antibiotic resistance in humans during a hearing on the reauthorization of pioneer and animal drug user fee programs.

April 10, 2013 | Daily News

The Obama administration is asking Congress to give FDA more funding to implement the new food safety law, finish upgrades of new laboratories and strengthen inspections in China, while also seeking savings in drug and device programs.

April 05, 2013 | Daily News

Industry groups are looking to free up medical product user fees that have been withheld from FDA due to sequestration and to exempt user fees from future budget cuts, changes sources said could happen in next year's spending bill but may not be likely this fiscal year.

April 05, 2013 | Daily News

Just last year, Congress and the Obama Administration came together on a bipartisan basis to reauthorize for the fourth time the very successful Prescription Drug User Fee program (PDUFA). Under this important legislation, companies seeking approval for their new cures and treatments pay user fees to the Food and Drug Administration (FDA) for the review of their therapies.

March 21, 2013 | Daily News

The Senate health committee Wednesday (March 20) by a voice vote cleared animal drug user fee legislation that mirrored the agreement negotiated between FDA and industry, clearing the way for floor consideration where animal antibiotics are expected to enter the debate.

March 18, 2013 | Daily News

Drug Risk Evaluation and Mitigation Strategies' inefficiencies highlighted recently by the HHS Office of Inspector General will help shape the dialogue at FDA's upcoming prescription drug stakeholder meetings, according to sources focused on the issue.

March 13, 2013 | Daily News

FDA plans to spend $700,000 this fiscal year to establish a cooperative agreement with Brookings Institution's Engelberg Center for Health Care Reform to conduct research, workshops and meetings related to Prescription Drug User Fee Act goals such as those for rare diseases, Risk Evaluation and Mitigation Strategies and patient-reported outcomes.

February 28, 2013 | Daily News

Implementation of the new generic drug user fee act is complicated by uncertainty over the budget and the looming cuts mandated by sequestration, according to FDA Commissioner Margaret Hamburg, who acknowledged at a recent meeting with generic drug industry executives that the agency was off to a slow start in reducing the backlog of abbreviated new drug applications.

February 27, 2013 | Daily News

The Obama administration is asking appropriators to include in upcoming funding legislation a provision allowing FDA to fully collect user fees associated with medical devices, generic drugs, biosimilars, animal drugs and tobacco products, according to a document obtained by Inside Health Policy that lists “anomalies” the White House Office of Management and Budget recently sent to lawmakers.

September 24, 2012 | Daily News

The Senate early Saturday morning approved a six-month continuing resolution and a bill allowing FDA to collect all generic drug user fees, sending both measures to the president for his signature.

September 21, 2012 | Daily News

FDA officials said Friday (Sept. 21) they plan to start the generic drug user fee program regardless of the outcome of congressional efforts to allow fee collection, as the lack of an appropriations measure affects when -- not if -- the fees will be collected.

September 20, 2012 | Daily News

The pharmaceutical industry is concerned that the administration's inclusion of FDA user fees among programs to be hit by the upcoming budget sequestration could permanently divert the industry-paid funding away from FDA, the head of the drug industry's trade group said Thursday (Sept. 20), a view echoed by the Biotechnology Industry Organization.