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White House: sequestration to hinder approvals

February 9, 2013 2:05 AM UTC

The White House said budget sequestration would lead to delays in new drug approvals and reduce FDA's ability to meet PDUFA V commitments. In a statement on Friday, the Obama administration said if sequestration occurs, FDA's Center for Drug Evaluation and Research (CDER) would "face delays in translating new science and technologies into regulatory policy and decision-making," which would lead to delayed drug approvals. The administration said FDA also would likely need to reduce operational support aimed at meeting review performance goals, including PDUFA V goals. The Alliance for a Stronger FDA has estimated that sequestration would likely cut FDA's appropriated and user fee budgets by at least 5%, or about $200 million.

The White House also said sequestration would force NIH to delay or halt scientific projects and make "hundreds of fewer" research awards. According to the Office of Management and Budget, sequestration would have about a $1.6 billion hit on NIH's current $30.9 billion budget. ...