During a Wednesday hearing before the House Energy and Commerce Subcommittee on Health, industry experts, consumer groups, government officials and other stakeholders testified on the recent negotiations with the FDA on user fees under the Medical Device User Fee & Modernization Act. The latest agreement between the device industry and the FDA calls for collection of $595 million over five years. During the hearing, industry officials and some members of the subcommittee were critical of the FDA's performance in providing consistent, timely review and approval of medical devices. "Delays in product approval, inconsistency in the review process, and the resulting downstream effects on investment and innovation have undermined the competitiveness of our industry and harmed patient access to new treatments, diagnostics, and cures," according to testimony from David Perez, Terumo BCT's president and CEO and a member of the board of directors of the Advanced Medical Technology Association.
Published in Brief: