Industry and the FDA may have mended fences over the future of the Medical Device User Fee &Modernization Act, but Center for Devices & Radiological Health chief Dr. Jeffrey Shuren and a distinguished gentleman from North Carolina still have some issues.
Shuren climbed Capitol Hill for a Senate Health, Education, Labor & Pensions committee hearing Thursday, selling a new future for the agency should the panel sign off on the new user fee agreement the federal watchdog agency signed with the med-tech industry.
The proposed deal, which the White House signed off on earlier this month, calls for a doubling of the fees companies pay to the CDRH to review medical devices in exchange for meeting certain performance goals.
Sen. Richard Burr (R-N.C.) grilled Shuren over the findings of a U.S. Government Accountability Office report, which concluded that the federal watchdog agency was "inconsistent in meeting performance goals for PMA submissions" and that decision times for 510(k) submissions have increased 61% from 2005-2010.
"Clearly, reporting on only the performance goals negotiated between industry and the FDA does not paint a full picture of the FDA’s performance and how well it has met its public health mission," Burr said. "I think it’s crucial and critical that we consider these issues as we work through the user fee reauthorizations."
Although the agency has come up with some strong concepts on how to improve the medical device review pathway, he added, "comments were made 5 years ago and they haven’t been met; a doubling of user fees isn’t going to make sure the agency meets its goal."
Shuren, who has been on the receiving end of Burr’s grilling several times over the past 2 years, including a testy exchange last November, answered authoritatively.
"The largest section of our commitment letter is dedicated to metrics," he said, reciting the copious number of datapoints the agency has collected over the past 5 years and projecting how many more it will collect under the new user agreement.
"At the end of [next] 5 years, we’ll have reported on more than 10 million data points … more than you’ll see for any other country," he said. "We’re being very transparent and we’re putting in tough metrics.
"I will note on the GAO report that they also talk about the actions we are taking to address the [issue]," Shuren said.
The 59-page report, "FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer," was released yesterday morning.
Prior to the hearing, Burr and Sen. Thomas Coburn (R-Okla.) released the following statement:
"Patients rely upon FDA to make sound medical decisions in as timely a manner as possible. Increasing regulatory uncertainty and unnecessary delays are stifling investments in the development of life-saving medical products. If Congress fails to ensure consistent oversight and transparency at FDA, we risk continuing to drive medical innovation and job creation overseas and jeopardizing American patients’ access to the most cutting-edge medical therapies and advances.”