User fee access safe for now; sequester still needs to be addressed


The Senate approved this week a continuing resolution (CR) that preserves House-passed language correcting an anomaly in the current CR that would have barred FDA from spending $40 million of the fees it is collecting from device and diagnostics companies.

“Last year, Congress passed with bipartisan support legislation to codify a groundbreaking new medical device user fee agreement that included a number of reforms and performance goals intended to improve FDA’s regulatory efficiency and predictability, in exchange for increased fee levels that have been paid since last October,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) in a statement released following the Senate’s approval of the CR.

“These improvements serve the interests of patients, industry and FDA,” said Ubl. “But the current CR that funds the government through the end of this month allowed the agency to access and spend only those device user fee amounts authorized for FY 2012. Passage of the new CR allows FDA to access and spend the increased fee levels while continuing to implement needed reforms.

Ubl went on to say that there’s more work to be done in order to ensure FDA has the resources it needs to fulfill its mission and urged Congress to reconcile the two versions of the CR and to address the sequester.

“The sequester, which triggered March 1, threatens FDA access to approximately $2.9 million in user fees for the device center this fiscal year alone, along with approximately $16 million in appropriated funding,” said Ubl, who stressed that the user fees are not taxpayer dollars and should, therefore, “not be considered in the same light as appropriated funding under the sequester. We look forward to working with Congress on a future legislative change to correct the sequester language and prevent any further restrictions on user fee access.”

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