Three U.S. senators seeking to speed up review times for medical devices have proposed two new bills for advisers to the Food and Drug Administration (FDA). The measure would reverse 2007 legislation that barred experts who had financial ties to a company or its competitor from serving on an advisory panel without a waiver. There is also a limit on the number of waivers that keeps decreasing.
A senior FDA drugs office official testified in August that the agency was having difficulty in recruiting highly qualified people for its advisory panels.
The legislation also comes as medical device makers such as Boston Scientific and Stryker have criticized the FDA for strangling innovation with inconsistent regulation and lagging device approvals.
“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,” according to a statement issued by the senators. Federal regulations allow those with conflicts to serve as advisers as long as the conflict is publicly disclosed and is “unavoidable.”
“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,” said Senator Amy Klobuchar, a Democrat from Minnesota who proposed the first bill. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”
Klobuchar plans to visit nine communities in western Minnesota this weekend as part of a rural economic tour. Klobuchar will visit Blomkest, Benson, Morris, Wheaton, Ortonville, Hendricks, Dawson, Granite Falls and Montevideo. Klobuchar added: “This rural economic tour is an important opportunity for me to meet with Minnesotans, listen to their concerns and see for myself the latest developments in their communities.”
Klobuchar proposed the bill along with Senator Richard Burr, a Republican from North Carolina, and Michael Bennet, a Democrat from Colorado. Similar legislation is likely to come from the House of Representatives in coming days, one congressional staffer said.
The second bill comes from Republican Rep. Erik Paulsen and shares elements of Klobuchar's bill. Paulsen said he's working closely with the House committee responsible for the bill and expects action on the measure next year.
Patient and consumer groups feel the FDA is not looking hard enough to find experts, and worry loosening the rules could jeopardize the independence of panels. They also point out the FDA does not use up all of its allotted waivers.