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Wanda Moebius
March 20, 2013

Continuing Resolution Gives FDA Expanded User Fee Access, But Work Remains to Address Sequester

WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement praising Congress for approving a new continuing resolution (CR) that addresses FDA’s access to user fees paid by industry for the rest of the current federal fiscal year:

“On behalf of AdvaMed, the world’s largest medical technology association representing manufacturers of medical devices and diagnostics, I would like to thank the Senate for approving a new continuing resolution 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. These improvements serve the interests of patients, industry and FDA. 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.

“There’s more work to do to ensure FDA has the resources it needs for its important mission. We urge Congress to reconcile the two versions of the CR and 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.

“The fees are voluntarily paid by industry to FDA in exchange for meeting certain performance goals and are not taxpayer dollars. They should 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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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.