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Reuters – Senators propose relaxing FDA conflict rules

Reuters – Senators propose relaxing FDA conflict rules


A bill that would loosen conflict of interest rules for advisers to the Food and Drug

Administration has been proposed by three U.S. senators seeking to speed up review times for medical devices.

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. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”

Minnesota, home to devicemaker Medtronic, has about 30,000 jobs in the medical device industry, according to AdvaMed, an industry trade group.

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.

Patient and consumer groups contend the FDA is simply 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.