News Feature | March 29, 2017

FDA, Industry Say MDUFA Renewal A Big Win For Patients, Medtech Innovation

By Jof Enriquez
Follow me on Twitter @jofenriq

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In the latest Congressional hearing to tackle 2017 User Fee Act (UFA) reauthorizations, FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren and representatives from industry groups pressed members of the House Energy & Commerce Committee’s (E&C) Subcommittee on Health to renew the Medical Device User Fee Amendments (MDUFA), which expires in September 2017 and must be reauthorized for the Fiscal Years 2018 to 2022.

Shuren testified last week before the Senate HELP (Health, Education, Labor, Pensions) Committee, and at the most recent hearing on March 28, he reiterated MDUFA's achievements in the last five years, which include faster device approval times and earlier introduction of innovative technologies in the United States.

He testified that renewing the user fee program for the next five years will build on past gains by supporting the launch of a new quality management program that will enhance consistency and predictability in premarket review processes, as well as the National Evaluation System for Health Technology (NEST) device surveillance program.

Also, MDUFA IV will allow FDA to seek additional patient input in benefit-risk determinations and to promote more patient-centric clinical trials.

"The reauthorization [of] MDUFA will allow FDA to build upon the demonstrated success of this program, and in so doing, further benefit patients and affirm our nation’s standing as a global leader in biomedical innovation," said Shuren.

Patrick Daly, CEO of Cohera Medical, who testified on behalf of the Advanced Medical Technology Association (AdvaMed), said that FDA's device center is "on the right track" and that the new user fee agreement will "keep things heading in the right direction to strengthen the medtech innovation ecosystem."

AdvaMed CEO Scott Whitaker added, "The new MDUFA package is a win-win-win for FDA, for innovation and, most of all, for patients. The user fee agreement negotiated between industry and the agency lays the groundwork for further FDA performance improvements – building on the success of the current MDUFA – through more ambitious performance goals, important process changes, and increased accountability, supported by significant additional resources."

On behalf of the Medical Device Manufacturers Association (MDMA), Robert Kieval, founder and Chief Development Officer of CVRx, testified that MDUFA IV "will further improve access for American citizens to safe and effective new medical technologies" and "can strengthen and provide increased confidence in the regulatory process."

Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, who testified on behalf of the Medical Imaging and Technology Alliance (MITA), said that MDUFA IV "will improve FDA review of medical devices, ensuring that American patients have timely access to safe and effective medical devices."

AdvaMed, MDMA, and MITA in August announced a draft agreement with FDA to reauthorize MDUFA, which is set to expire on Sept. 30, 2017. The MDUFA five-year reauthorization proposal was submitted to Congress in January. Related, President Donald Trump’s "budget blueprint" proposes to double the amount of user fees.

According to Lexology, Congress will leave for summer break after July 27, which is likely the operative "drop-dead date" by which all user fee agreements need to be signed into law. Once enacted, MDUFA IV will be in place from Oct. 1, 2017 until Sept. 30, 2022.

Rep. Michael C. Burgess, M.D. (R-TX), Chairman of the House Energy and Commerce Subcommittee on Health, said of the latest hearing, "Reauthorizing MDUFA and the user fee programs we have previously discussed would increase efficiency at FDA and ensure that American patients benefit from advances in biomedical technology and innovation as soon as safely possible."