U.S. Senators Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) have introduced a bill (S. 1700) aimed at reducing “regulatory burdens that unnecessarily delay new medical devices from reaching the market.” The Medical Device Regulatory Improvement Act would, among other things, expedite review times for medical devices by rolling back the conflict-of-interest rules adopted in 2007 for experts serving on the Food and Drug Administration’s (FDA’s) advisory committees.
According to the lawmakers, FDA’s “overly stringent” conflicts rules make it difficult for the agency to find qualified experts to serve on advisory committees, causing delays in the review process. By making FDA committee members subject to the provisions applicable to other federal agencies under the Ethics in Government Act of 1978, the measure would no longer prohibit experts with financial ties to industry from serving on FDA advisory panels without a waiver. Consumer advocates are reportedly concerned that relaxing these rules could jeopardize the panels’ independence.
The bill would also (i) amend FDA’s premarket approval process to require consideration of “alternative approaches to evaluating device safety and effectiveness in order to reduce the time, effort, and cost of reaching proper resolution of the issue”; (ii) narrow the agency’s focus under its “substantial equivalence determination” rules, including a provision that would require FDA to “review the labeling of the device to assess the intended use of the device,” while precluding an evaluation of “issues that do not present a major impact on the intended use as set forth in the labeling”; and (iii) impose a “management and innovation review” 60 days after the bill’s enactment under which FDA would contract with an outside entity to review the management and regulatory processes of the agency’s Center for Devices and Radiological Health for “potential impacts on innovation with respect to medical devises.”
“Recent studies showed that the average time to approve a 501(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%,” the lawmakers said. “A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges. . . . These provisions will ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.” See Sens. Klobuchar, Burr and Bennet Press Releases and Reuters, October 13, 2011.