New measures introduced in 2007 to restrict medical devices experts with potential conflicts of interest from advising the US Food and Drug Administration are too stringent, say Senators who are proposing new legislation to relax regulations that they say are getting in the way of bringing innovative products to market.
In a joint statement on Thursday, US Senators Amy Klobuchar (Democrat from Minnesota), Richard Burr (Republican from North Carolina), and Michael Bennet (Democrat from Colorado), said:
“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, 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.”
The Senators said recent studies have shown that the average time taken for a new medical device to obtain 510(k) clearance has gone up by 43% from the 2003-2007 period to 2010, and the average time to obtain a premarket approval (PMA) application has gone up by 75%.
“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,” they added.
The proposed Medical Device Regulatory Improvement Act would also require that the FDA engage an independent body to carry out a thorough review of the management and regulatory processes at the Administration’s Center for for Devices and Radiological Health. The review would also assess the impact these processes have on medical device innovation.
Klobuchar said it was crucial to stop regulatory burdens getting in the way of delivering lifesaving products to patients. She also told Minnesota Public Radio that:
“Not only will this give us a faster, more efficient process that will lead to more jobs, I think we can also improve the quality.”
According to industry trade group AdvaMed, about 30,000 Minnesotans are employed in the medical devices industry, reports Reuters news agency.
A similar bill that shares elements of the one being proposed in the Senate is being proposed in the House of Representatives by Erik Paulsen, Republican Representative for Minnesota. He told Minnesota Public Radio he is working closely with the House committee responsible for the bill and expects action on the measure next year.
Burr made the point that the measure represents a “key step toward restoring America’s leadership in the research and development of life-saving products,” and it upholds the promise that was made to “patients in North Carolina and around our nation to continue innovating on their behalf.”
Bennet said “Colorado is a hub of the life science industry and innovation,” and the bill will boost national economic competitiveness and give medical device developers and manufacturers “regulatory clarity and predictability” in order to grant “patients the greatest access to lifesaving products”.
In August this year, a senior FDA official testified that the agency was finding it hard to recruit experts for advisory panels, reports Reuters.
However, patient and consumer groups argue that the FDA is not looking hard enough and are concerned that relaxing the regulations could make panels less independent. They also maintain the FDA don’t make enough use of the waivers they are allowed to implement in the existing legislation that permit experts with potential conflicts of interest to serve on panels.
Written by Catharine Paddock PhD