Shuren To Lawmakers: Sequestration Is “Killing Us

Article preview from "The Gray Sheet"- November 15, 2013

CDRH Director Jeffrey Shuren fears the center won’t be able to meet commitments to hire new employees for FY 2014 if the sequester continues, he told members of the House Energy & Commerce Health Subcommittee last week.

Shuren To Lawmakers: Sequestration Is “Killing Us

Article preview from "The Gray Sheet"- November 15, 2013

CDRH Director Jeffrey Shuren vented his frustrations on Capitol Hill Nov. 15 with how the sequestration of FDA funding is impacting the device center’s ability to hire new employees and continue improving its review programs.

Lawmakers discussed with Shuren and FDA drug center Director Janet Woodcock about how the impact of the mandatory budget cuts on the respective centers’ implementation of the FDA Safety and Innovation Act during a House Energy & Commerce Health Subcommittee hearing.

FDA has faced $209 million in budget cuts due to sequestration in FY 2013, which, according to prior reports, included $85 million in industry-paid user fees. However, Woodcock said at the hearing it is more likely only $79 million in sequestered user fees.

Rep. Kathy Castor, D-Fla., estimated at the hearing that if the sequester is not replaced, FDA will face a cut of $319 million in FY 2014, which would include a $112 million cut in industry-funded user fees.

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