The Subcommittee on Health held a hearing on Feb. 15, 2012, entitled, “Reauthorization of the Medical Device User Fee Act (MDUFA): What It Means for Jobs, Innovation, and Patients.” During the two-hour hearing, members of Congress and the medical technology industry discussed issues involved with the new user fee agreement and the ongoing negotiation between FDA and industry.

AdvaMed, Washington, DC, is working with Congress, FDA, and other stakeholders to help ensure that the agreement and related legislative reforms win approval before the Sept. 30 deadline, according to AdvaMed president and CEO Stephen Ubl.

“The agreement has the potential to be a game-changer because of its series of strong, measureable performance goals that will bring much-needed improvements to the efficiency and consistency of FDA’s medical device review process,” said Ubl in a statement released after the hearing. “Ultimately, we believe the agreement will accelerate the development and approval of safe and effective treatments and diagnostics, helping FDA, industry, and, most importantly, patients.”

Ranking Subcommittee Member Harry Waxman (D-CA) described the user fee proposal agreement as a “hard-fought compromise.” While pleased that an agreement has been reached and is being reviewed for reauthorization, Waxman said he would prefer a process that would enable FDA to do its job without a user fee. “[But] I have very little faith in Congress to provide the appropriations for the FDA to do the job without a user fee,” he said. “Those who don’t like the user fee will have to acknowledge that FDA will be short-funded and we won’t get these devices approved as quickly as possible.”

Jeffrey Shuren, director, CDRH, FDA, agreed that adequate and stable funding is a key component to FDA’s and industry’s success in bringing safe and effective devices to market quickly and efficiently. “While it is true that providing more user fee resources won’t solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to, several of these problems,” Shuren said. “

The new agreement discussed at the hearing provides FDA with the resources it needs to meet the new goals it outlines, according to Ubl. He added that the agreement will require consistent and efficient administration by FDA leadership, as well as appropriate congressional oversight. “We believe it is in the interests of patients and the American economy that this agreement functions well, and we will work with FDA to make that happen,” said Ubl.

Shuren described several aspects of FDA’s efforts to improve its premarket programs internally but said that neither FDA, nor industry, believe that the user fee program has reached the level of performance, or produced the extent of benefits that it has the potential to achieve. “[M]edical device industry and CDRH must continue to work together to ensure that the center receives high-quality submissions that contain the information we need to make well-informed and timely decisions,” Shuren added. “Finally, CDRH must have adequate and stable resources to get the job done right and quickly. Timely reauthorization of MDUFA, as well as the Congressional appropriations process, is critical to achieving [the Center’s] goals.”

In his statement, Ubl also thanked the members of the Subcommittee for holding the hearing and AdvaMed board member David Perez, president and CEO, Terumo BCT, Lakewood, CO, for testifying on behalf of industry. “The user fee agreement our industry representatives just concluded with the agency is a huge step in the right direction,” said Perez. “It is good for industry. It is good for FDA. And most of all, it is good for patients.”

Testimony at the hearing was also provided by Elisabeth George, vice president, global government affairs, regulations, and standards, Philips Healthcare; Ralph Hall, J.D., professor and practitioner, University of Minnesota Law School; Ross Jaffe, MD, managing director, Versant Ventures; Aaron Kesselheim, MD, JD, MPH, assistant professor of medicine at Harvard Medical School, division of pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital; Art Sedrakyan, MD, PhD, associate professor and director, Patient-Centered Effectiveness Program, Weill Cornell Medical College and New York Presbyterian Hospital; Lisa Swirsky, senior policy analyst, Consumers Union; and Jim Shull, a private citizen and end-user from Browns Mills, NJ.