Sen. Franken to Introduce Device Legislation

Sen. Al Franken (D-Minn.) is preparing to introduce his own medical device legislation, according to the Minneapolis Star Tribune. The new legislation follows similar proposals released last month in the House and Senate.

The senator was visiting a Medtronic Inc. facility in the Minneapolis area on Monday, where he announced that he will introduce a bill that could speed up the approval for devices to treat rare diseases.

At present, companies that receive a Humanitarian Device Exemption (HDE)—which is received for devices that treat fewer than 4,000 people a year—from the U.S. Food and Drug Administration can’t profit on those devices unless they used in the pediatric market. The bill also would address the issue of industry experts serving on FDA panels to offer recommendations on medical devices for rare diseases.

Franken told the newspaper that he believes the current structure of the panels is “subjected to overly stringent rules” that make it difficult for the agency to tap outside expertise due to perceived conflicts of interest. Franken said his proposal would have the panels comply with other conflict-of-interest rules that the National Institutes of Health uses.

Last month, U.S. Sen. Amy Klobuchar last month introduced a bill, co-sponsored by Sen. Richard Burr (R-N.C.) and Michael Bennet (D-Colo.), which also included a provision to loosen restrictions placed on the use of advisory panel experts. Franken was a co-signer of the proposed legislation.

“Times are tough across the country and in Minnesota, but the medical technology industry gives me confidence that we will get through these difficult economic times,” Franken said in a statement posted on his office’s website. “As a nation, we need to do more to support this industry so it can continue to expand and provide high-quality jobs—not to mention life-saving technologies—to our markets and our hospitals.”

According to the senator’s office, the bill would: “Promote the development of devices to treat patients with rare diseases and would help improve the federal Food and Drug Administration’s approval process for medical devices by allowing the agency to more easily consult with experts. The legislation would also lift the current profit cap on all medical devices that receive FDA exemptions that allow the product to get to market much faster.”

It is uncommon for medical technology firms to manufacture products under an HDE, which requires that firms to prove the product is safe and that its benefits outweigh the risk of injury. Companies don’t have to show clinical evidence that the product is effective, however, which raided the ire of watchdog group Public Citizen, which argued that companies shouldn’t be able to profit without proving the legitimacy of the device, according to the Tribune.

As of Tuesday, Nov. 15, the legislation had not been released.