House Republicans have recently introduced 10 bills that, collectively, aim at increasing the predictability, consistency and transparency of the FDA’s medical device review and approval process. Legislators summarized their concerns in an Oct. 14 memorandum sent to the Energy and Commerce Committee, detailing the proposed measures designed to reform the medical device review and approval process.
“Unfortunately, our nation’s medical device leadership is under threat. The threat comes from FDA’s unpredictable, inconsistent and non-transparent regulation of medical devices,” the signatories wrote. “The current regulatory environment created by the FDA has forced some device companies to cut American jobs and move overseas. It also has hurt American patients because the approvals of life-saving and life-improving treatments have been delayed or denied. Finally, it has harmed American innovation as venture capitalists and other investors no longer view the U.S. device companies as good, reliable investments.”
Based on previous testimonies from industry experts and stakeholders, Republican legislators cautioned that the U.S. will lose its position as a world leader in medical device innovation unless the current regulatory environment at the FDA is reformed. Legislators cited reports from the leading research firms that back up their claims.
The following bills make up the 10 proposed actions to improve medical device regulation:
- The Premarket Predictability Act, authored by Rep. John Shimkus, R-Ill.;
- The Novel Device Regulatory Relief Act of 2011, authored by Rep. Brian Bilbray, R-Calif.;
- Keeping America Competitive through Harmonization Act, authored by Rep. Cathy McMorris Rodgers, R-Wash.;
- FDA Renewing Efficiency From Outside Review Management Act of 2011, authored by Rep. Erik Paulsen, R-Minn.;
- Humanitarian Device Reform Act of 2011, authored by Rep. Charles Bass, R-N.H.;
- Patient Come First Act, authored by Shimkus;
- Cultivating Scientific Expertise to Foster Innovation Act, authored by Rep. Michael Burgess, R-Texas;
- Food and Drug Administration Mission Reform Act, authored by Rep. Mike Rogers, R-Mich.;
- Modernizing Laboratory Test Standards for Patient Act, authored by Burgess;
- Guidance Accountability and Transparency Act, authored by Rep. Brett Guthrie, R-Ky.
The proposed bills received praise from the Advanced Medical Technology Association (AdvaMed), a trade association representing medical device manufacturers, makers of medical equipment, medical software and medical supplies.
“These bills reflect the Energy and Commerce Committee’s extensive work in examining the need for reform through hearing and debate. We support this effort because it is an excellent starting point in a legislative discussion that will address several important issues critical to maintaining our global leadership and competitiveness,” said Stephen J. Ubl, president and CEO of AdvaMed, in a statement.