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AdvaMed’s Whitaker Urges Congressional Action on MDUFA


WASHINGTON, D.C. – Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker testified before the Senate HELP Committee today on reauthorization of the Medical Device User Fee Act (MDUFA), stressing the urgent need for Congress to move forward with the agreement as negotiated between FDA and industry.

“The MDUFA IV agreement lays the groundwork to build on recent FDA performance improvements through more ambitious goals, important process changes and increased accountability, supported by additional resources,” Whitaker said.

“We strongly support the vital improvements made by the new agreement and believe that a failure to act would have a destructive impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients,” he cautioned.

While focusing on the benefits of the negotiated MDUFA agreement for patients, FDA and innovation, Whitaker noted that there were additional legislative reforms Congress could consider outside the parameters of the negotiated agreement to “enhance and compliment the underlying user fee agreement” that will “maximize[s] the opportunity for success at the agency, which should be the shared goal of all involved.”

As one example, he cited bipartisan legislation recently introduced in both the House and Senate that designed to improve the consistency and transparency of FDA inspections and to move to a risk-based system for inspections. “These common-sense proposals will ensure that FDA’s inspections resources are best targeted to public health needs and that companies and FDA are working together,” Whitaker said.

He called on the Senate HELP Committee and its counterparts in the House to “act promptly to reauthorize this program, which is so critical to our industry, to the FDA, and to patients.”

A copy of Whitaker’s written testimony can be viewed here.