As we noted last week, a group of bipartisan Senators including Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and Michael Bennet (D-CO) introduced The “Medical Device Regulatory Improvement Act (S. 1700) “to help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients.” The legislation would help streamline the Food and Drug Administration’s (FDA) regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker without compromising consumer safety.
More importantly, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government, under the Federal Advisory Committee Act. The legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation.
A companion bill in the House was also introduced by Representative Erik Paulsen (R-MN) and an equally impressive group of bipartisan legislators. The FDA Renewing Efficiency from Outside Review Management Act of 2011 (H.R. 3205) reauthorizes the third party inspection program and reforms the third party review program to foster better participation, decrease approval times and conserve FDA resources.
Additionally, last week, Congressman Michael Burgess, M.D., (R-TX) introduced The Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 (H.R. 3206) to help FDA obtain expert advice on advisory committees by eliminating limits on the number of conflict of interest waivers FDA can issue. The bill would instruct the Department of Health and Human Services (HHS) Secretary, when considering potential conflicts of interest, to consider the totality of the type, nature and magnitude of any financial interest, without focusing on any one factor over another.
Although the Burgess bill does not directly touch upon CME, his office was represented at the CME Coalition briefing last month. In announcing the legislation, Dr. Burgess noted that:
We need to improve the FDA process for the products they do regulate and that is why we need to ensure the most qualified experts are available to the agency. In the important task of evaluating products that can improve the health of American patients, we want the best of the best. Setting arbitrary waiver limits not only clogs the already overwhelmed FDA process, but encourages membership by lesser qualified individuals. In the arena of life-altering medical treatments, this is unacceptable. Long delays due to vacancies and panels with lesser qualified members put lives unnecessarily at risk.
It should be noted that the House bills above, are included in a package of ten (10) bills that the House Energy and Commerce Committee is considering. In a press release, the Committee called these bills “Ten Specific Solutions to Top Ten Challenges in Current Review Process that Slow Access to Vital Devices.” Other pieces of legislation include proposals that would change premarket predictability, the 510(k) process, and humanitarian device reforms. It is likely that members of both the Senate and House will try to get these pieces of legislation included in the Prescription Drug User Fee Act (PDUFA) V negotiations. A draft bill will most likely come sometime next summer.