A congressional panel is calling fora new, expedited priority review process for medical technology aimed at unmet medical needs, similar to similar programs for drugs and biologics.
The recommendation came in a discussion document released by the 21st Century Cures Panel, a bipartisan committee led by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.). The panel spent the last 8 months holding roundtable discussions with medical stakeholders across the country, before releasing its report today.
The panel made several recommendations meant to accelerate medical innovation in the 21st century, including several suggestions for modernizing the regulatory process at the FDA and Centers for Medicare & Medicaid Services.
The proposed priority review for medtech would "authorize FDA to implement similar, though not identical, regulatory concepts that have proven successful on the drug side, while expanding the scope of valid scientific evidence FDA should consider in the review of such products," according to the panel.
The legislators want the FDA to follow a statutory framework developed by Rep. Joe Pitts (R-Pa.) to establish a priority review program for "breakthrough technologies that meet certain qualifying criteria," the panel recommended.
"A specifically assigned review staff, led by senior agency personnel, will collaboratively work with the sponsors of such devices to expedite their development, including early agreement on trial designs and endpoints. Should a sponsor of a device that met the criteria for priority review opt to apply for accelerated approval, FDA could approve the device upon a determination that it has an effect on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit," according to the panel’s report.
The panel also called for modernizing the way drug and device companies present the benefits of their products online.
"FDA’s current rules and policies governing what drug and device developers may say about their own products were designed decades ago. Since then, the way that medicine is practiced and delivered and the way that information is communicated have fundamentally changed. Patients and providers are increasingly turning to the Internet for information on potential treatment options. FDA must reconsider its regulation of manufacturer communications in this space," according to the report.
Rep. Billy Long (R-Mo.) is charged with leading another panel tasked with clarifying the proposed changes.
AdvaMed CEO Stephen Ubl applauded the release of the discussion guide in a written statement today.
"AdvaMed commends chairman Upton and congresswoman DeGette for their leadership on the 21st Century Cures initiative. We share their goal of accelerating the discovery, development and delivery of cures for patients, and we applaud their leadership on this important issue," Ubl wrote. "The medical technology industry is central to the development of technologies and diagnostics that will provide the life-saving and life-enhancing treatments of the future. But the innovation ecosystem that supports our industry is severely stressed. Policy improvements are essential if America is to retain its world leadership and the potential for medical progress in this century of the life sciences is to be fulfilled."