The president and CEO of the Advanced Medical Technology Association has issued a statement encouraging the U.S. House of Representatives to reauthorize the Medical Device User Fee Act, according to a news release.
The statement from Stephen Ubl was issued earlier this week in advance of the House's Energy and Commerce Committee's mark ups of legislation to reauthorize the bill.
The statement reads as follows:
"AdvaMed is pleased the House is continuing to move this important piece of legislation forward. Coming soon after the legislation received strong, bipartisan support from the Senate HELP Committee, we are encouraged that the House's actions this week means both chambers are poised to pass the reauthorization in an expeditious manner.
"Prompt passage of the reauthorization is essential to patients, the medical technology industry and FDA. The user fee agreement reached between FDA and industry and implemented by this legislation is a potential game-changer for all parties that could help accelerate the development and approval of safe and effective treatments and diagnostics.
"The agreement includes a number of groundbreaking accountability and transparency measures that, combined with enhanced resources for FDA, will help increase the predictability, consistency and efficiency of the agency's stringent review process. This translates into more timely access to life-changing treatments and cures for millions of patients worldwide.
"The U.S. medical technology industry is proud to be an American success story. Across the country, we have created high-paying jobs for more than 400,000 individuals who are committed to making a difference in patients' lives. Counting both direct and indirect employment, we are responsible for more than two million American jobs. Reauthorization of FDA's user fee program is crucial to the industry's continued success.
"Put simply, the user fee agreement is good for FDA; it is good for industry; and most of all, it is good for American patients.
"AdvaMed is committed to working with Congress, FDA and other stakeholders to help make sure the agreement — along with legislative reforms that do not change the terms of the agreement or undermine its goals — is passed promptly."
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