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April 4, 2017



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Congress Talks Medical Device User Fee Act

On Tuesday, March 29, 2017, the Health Subcommittee of the House’s Energy and Commerce Committee held the third of its hearings on the reauthorizations of the User Fee Acts, due to expire on September 30. Tuesday’s hearing was devoted exclusively to the Medical Device User Fee Act (MDUFA), as committee members discussed the provisions of MDUFA IV and negotiated among industry stakeholders and officials at the Food and Drug Administration (FDA).

On hand to answer the subcommittee’s questions was Dr. Jeffrey Shuren, the Director of the FDA’s Center for Devices and Radiological Health. In his opening statement, Dr. Shuren described many of the improvements MDUFA IV will make to the Act’s previous incarnation: “MDUFA IV agreement includes a new quality management program that will enhance consistency and predictability in premarket review processes. MDUFA IV agreement would also allow FDA to move forward in some critical and strategic areas such as strengthening our partnerships with patients. Strengthening patient input will allow us to promote more patient-centric clinical trials, advance benefit-risk assessments that are informed by patient perspectives, and foster earlier access to new devices. Another critical area supported by the MDUFA IV agreement is the development of the National Evaluation System for health Technology, or NEST.”

The NEST in particular drew the support and interest of many subcommittee members. Once it is formally launched, NEST will be a non-governmental system designed to facilitate the use of real world evidence (a central goal of MDUFA IV) from electronic health records and registries. The importance of long-term longitudinal data was also stressed when Rep. Frank Pallone (D-NJ) asked Shuren about the importance of unique device identifiers (UDI) on claims forms. In his answer, Shuren stressed the importance of this element in contributing to the “rich body of evidence” that the FDA has to utilize in making its decisions.

“[Tthe Food and Drug Administration Safety and Innovation Act (FDASIA)] included meaningful regulatory reforms, improved communication between industry and FDA, and increased accountability at the Center for Devices and Radiological Health (CDRH). It is important that the next medical device user fee agreement continue to build upon the progress made in FDASIA, as well as the good policies members of this subcommittee championed in the 21st Century Cures Act,” said Chairman Michael Burgess (R-TX). “I am encouraged that the proposed agreement transmitted to Congress in January contains many promising elements that will be good for FDA, industry, and most importantly, patients.”

Rep. Fred Upton (R-MI) highlighted the artificial pancreas as an innovative advancement made possible through this process. In this exchange with Dr. Jeffrey Shuren, Director of FDA’s CDRH, Rep. Upton asked what other once-thought impossible advancements are on the horizon. Dr. Shuren said we can expect to see more user robotics and less invasive surgeries – like using an ultrasound for a surgical procedure instead of a scalpel. “I think the U.S. can truly be the world’s leader if we continue on the trajectory we’ve been on,” stated Dr. Shuren.

Several committee members voiced opposition to the suggestion that this draft proposal—negotiated over the course of last year and transmitted to Congress by the end of 2016—be reopened, as President Trump has suggested. Both Chairman Burgess and Ranking Member Gene Green (D-TX) expressed their intent to move this agreement (as well as the other UFAs) through committee expeditiously. Chairman Burgess concluded the hearing by reminding witnesses, “The goodwill exists to get this done… Everyone wants this process to conclude successfully.”