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User Fees

October 18, 2013 | Daily News

FDA can accept and spend all fiscal 2014 user fees under a short-term spending measure passed this week but the agency may miss some goal dates associated with the biosimilar user fee program, which was the only user fee program halted during the 16-day government shutdown.

October 09, 2013 | Daily News

Canceled and postponed advisory meetings and public workshops resulting from the continued government shutdown could have serious long-term ramifications for product approvals, according to several sources.

October 03, 2013 | Daily News

FDA singled out a facility in Germany for neither identifying itself with the agency nor paying generic drug facility fees, according to the first public warning letter the agency issued under the new user fee program created by last year's FDA Safety and Innovation Act.

September 27, 2013 | Health Exchange Alert

CMS formally approved Arkansas' highly watched Medicaid expansion waiver -- which many see as a potential model for other states -- to place the expansion population into the state's federally run exchange with a state-provided subsidy, rather than expand the traditional Medicaid program. Arkansas submitted an 1115 waiver request in August, and under the Private Option demonstration approved Friday (Sept.

September 20, 2013 | FDA Week

Physician lobbyists say their chances of replacing the Medicare Sustainable Growth Rate formula are slipping away as Congress gets caught up in a standoff over funding the government and raising the debt ceiling. But there's also another problem: House freshmen conservatives don't consider SGR a priority, and, if lobbyists can't convince them that it is, GOP leadership is not inclined to include a fix to the Medicare physician pay formula in debt ceiling talks, sources say.

September 11, 2013 | Daily News

FDA exceeded fiscal 2013 hiring goals for the new generic drug user fee program by hiring 234 new employees, according to a recent internal FDA memo.

September 11, 2013 | Daily News

Funding advocates are bracing for possible cuts to health agencies and programs, and a possible government shutdown, after House Republican leadership postponed votes on a short-term funding measure Wednesday (Sept. 11). Political brinksmanship over the budget, including efforts to de-fund the Affordable Care Act, is taking center stage as the debate over whether to intervene in Syria is deferred, according to a funding source.

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.