The head of FDA's device arm, Jeffrey Shuren, during a March 28 hearing on Capitol Hill, warned of a sharp reduction in staff if Congress fails to reauthorize the medical device user-fee program.
Medical device companies help fund the agency's oversight of their products by paying user fees, which contribute to faster reviews. Under an agreement reached in 2016 between the medical device industry and the FDA, the agency is set to receive $995 million in such fees over the next five years beginning in October 2017, up from $595 million during the current five-year period.
But first, Congress needs to approve those terms by passing the so-called Medical Device User Fee Amendments, also known as MDUFA. The current user-fee agreement expires on Sept. 30.
"If MDUFA were to sunset and not get reauthorized in time, we'd lose about a third of our staff," Shuren told representatives serving on the House Energy and Commerce Committee. "It's about 60 days before the law sunsets that we need to start the process on a reduction in force."
While the recent passage of the 21st Century Cures Act showed bipartisan support for funding the FDA, Congress could seize the opportunity to add on riders to the user-fee bill that makes other changes to the regulation of the medical device sector. In particular, two members of the committee recently introduced a bill regulating lab-developed diagnostic tests that could pass as part of the user-fee bill, according to Cowen and Co. policy analyst Eric Assaraf. In addition, committee members on March 28 introduced a bill to reform the FDA's medical device inspection process.
Medical device industry lobbying group AdvaMed called for swift authorization of the user-fee program in a March 28 statement. AdvaMed told S&P Global Market Intelligence in an email that it supports including the inspection process bill in the legislation as a "rider."
Gleaning data from patient encounters
The agreement between the industry and FDA calls for $10 million and two additional full-time employees to develop the so-called National Evaluation System for Health Technology, or NEST. The initiative is supposed to efficiently generate better evidence for device evaluation and decision-making, according to the FDA website.
Shuren repeatedly cited the program during the hearing. "One of the great inefficiencies we have in our healthcare systems is that we gather information every single day in patient encounters, but we can't make great use of it because it may not be standardized, it may be incomplete, it may be of poor quality," he said. Companies that leverage post-market registries have been able to cut the costs of FDA-mandated studies in half, he said.
The agreement also calls for 12 new full-time employees and $3.5 million to support the increased use of patient-preference information and patient-reported outcomes in applications for FDA approval.
Shuren indicated that the initiative would help companies get products on the market. "Patients, especially those with rare conditions, are willing to accept more uncertainty for treatment, and so we need to be willing accept that uncertainty, too."
Shuren also highlighted the international Medical Device Single Review Program. Under such a system, decisions to approve devices by other healthcare regulatory agencies, such as those participating in the International Medical Device Regulators Forum, would be relied upon in other jurisdictions, Shuren said. The agreement would provide $14 million in funding for such so-called harmonization efforts.
Representatives noted that the FDA device center's improved performance under the current user-fee agreement. Average review times for innovative devices have fallen by 150 days, or 35%, since 2012.