U.S. Senator Amy Klobuchar today announced that a coalition of 77 patient advocacy groups endorsed reforming the selection process for medical device advisory committees, a key concept included in Klobuchar's legislation to help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients. In a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee, the organizations called to change restrictions for qualified experts to serve on the advisory committees, also known as conflict of interest reform. The groups did not endorse a specific reform proposal.
"It is critical that we don't allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them," Klobuchar said."Current restrictions on medical device advisory committees are resulting in a lack of experts to serve on these committees, causing unnecessary delays for patients -- delays that can cost lives and hinder innovation. Patients and their advocates understand the need to get rid of this type of red tape, and their support is critical to moving this legislation forward."
"The main goal of these committees, after all, is to help the FDA to make the best decisions possible. The FDA can only do that if it has the best, most well-informed researchers, clinicians, and patients advising it," the patient advocacy groups said in their letter.
Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, Klobuchar's legislation, the Medical Device Regulatory Improvement Act, 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.
Klobuchar's legislation would also help streamline the FDA's regulation of medical devices by clarifying FDA's current least burdensome requirements. 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.
Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.