AdvaMed fights to keep user fees out of sequester cuts for FDA

February 26, 2013 by Brian Johnson

With more than 5% of the FDA's budget on the chopping block this week, medical device industry lobby AdvaMed vows to fight "shoulder to shoulder" with the watchdog agency to avert cuts that could impact medical innovation.

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The medical device industry doesn't want user fees paid by industry to be included in a series of cuts slated for the FDA's budget this week.

The federal watchdog agency will have $210 million, or about 5.1% of its $4.1 billion budget, cut from its 2013 budget March 1 as a result of sequestration, the bargain between the White House and Congress.

Included in those cuts are the user fees medical device and pharmaceutical companies pay in order to insure timely reviews of new drugs and devices.

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AdvaMed, the industry's lobbying voice in Washington, D.C., said today that it's prepared to stand "shoulder to shoulder" with the agency to protect the agency from those cuts.

"The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding," Zimmer (NYSE:ZMH) CEO and AdvaMed board chairman David Dvorak said during a conference call. "The FDA should have full access to fees paid by industry and the agency should be properly funded to meet its obligations under the new user fee agreement."

The medical device industry is prepared too "stand together, shoulder-to-shoulder with the FDA regarding negative impacts of sequestration and continuing resolution on the device center's operations. Everyone knows how much effort we've put in towards improving performance in the device center and highlighting the role the agency plays in maintaining our global leadership," added AdvaMed president Steven Ubl. "Simply put, I think we've come too far to see these gains unraveled due to ill-considered approaches [to federal spending]."

Should the March 1 sequestration deadline pass, the fiscal 2013 impact will amount to an across-the-board cut of between 5.1% and 5.3% to the FDA's appropriated budget, which includes the user fees, according to AdvaMed.

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