Article preview from "The Gray Sheet" - March 04, 2013
FDA does not plan to furlough employees as a result of the across-the-board cuts to federal agencies that took effect March 1, but the shortfall will limit some “activities that have already been specifically designated and paid for with user fees.” The administration also took a step to convince Congress to give FDA full access to its user fees.
Article preview from "The Gray Sheet" - March 04, 2013
The across-the-board federal sequestration cuts that officially took effect March 1 are expected to inhibit FDA’s ability to conduct pre-market reviews, but the extent of the impact remains to be seen.
The sequester was enacted by the Budget Control Act of 2011 to make sweeping cuts to all government agencies. Legislation signed by President Obama earlier this year delayed the sequester until March 1 to allow Congress to reach a deal, but despite much posturing by both parties on the Hill and some attempts to approve legislation to replace the deficit-cutting measure with a balance of more targeted government funding cuts – and perhaps some revenue increases – legislators missed their deadline.
An FDA spokeswoman said that, unlike some other agencies, FDA does not anticipate having to furlough its employees. The agency has not sent out the draft OMB memo meant to inform employees of the potential need for furloughs. But, “Other internal measures to absorb the cuts due to sequester will be taken, including reducing travel and training,” noted spokeswoman Michelle Bolek in an emailed statement.
Under sequestration, “FDA Centers would face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in new approvals,” Bolek said. “We would not be able to undertake program activities that have already been specifically designated and paid for with user fees.”
The White House signaled in a report issued in advance of the sequester deadline that FDA would “need to reduce operational support for meeting review performance goals, such as the recently negotiated user fee goals on new innovative prescription drugs and medical devices.”
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