Franken bill would reduce FDA red tape

  • Article by: WENDY LEE , Star Tribune
  • Updated: November 14, 2011 - 9:42 PM

Sen. Al Franken told Medtronic employees Monday he backs efforts to spur development of medical devices treating rare diseases.

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U.S. Sen. Al Franken walked with Peter Slone, a Medtronic vice president, after speaking to company leaders and employees on Monday morning.

Photo: Richard Sennott, Star Tribune

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Showing his support for Minnesota medical device manufacturers upset with the U.S. Food and Drug Administration, Sen. Al Franken came to Medtronic Monday where he announced that he will introduce a bill that could speed up the approval for devices to treat rare diseases.

"There needs to be more discussion between the regulatory agencies and the industry," Franken said, after speaking to a crowd of 800 Medtronic employees. "There is a real difference in the culture."

Franken, D-Minn., said he will propose legislation Tuesday that will let medical device companies profit on devices that treat conditions that affect fewer than 4,000 people a year. Currently, medical device firms can't make money from these devices, unless they are for children.

The bill also makes it easier for some medical experts to serve on FDA panels that offer recommendations on medical devices for rare diseases. Franken said he believes the current structure of the panels is "subjected to overly stringent rules" that make it difficult for them to use outside experts because of perceived conflicts of interest with the private sector.

Franken said his proposal would have the panels comply with other conflict-of-interest rules that the National Institutes of Health uses.

"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," Franken said in a statement.

The FDA declined to comment on Franken's proposal. Franken's bill was not available on Monday.

Franken's bill comes on the heels of similar legislation filed by U.S. Sen. Amy Klobuchar last month. That bill, which is co-introduced by Sen. Richard Burr, R-N.C., and Michael Bennet, D-Colo., also aims to loosen the restrictions placed on experts who can serve on advisory panels for medical devices.

Thom Gunderson, a medical technology analyst with Piper Jaffray Cos., said the pendulum has swung too far on the types of experts excluded from FDA advisory panels, adding that it's hard to find people who haven't worked in the private sector.

"If Sen. Franken wants to resolve that and get us back to common sense, that is a reasonable effort," Gunderson said.

But Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, opposed Franken's proposal and said he believes the FDA can find sufficient experts who don't have a conflict of interest. Such conflicts "may lead to biased reviews, rather than objective reviews on whether the device is safe and effective," Carome said.

While Franken's legislation seeks to loosen rules associated with getting devices for rare ailments approved, the market for such devices is small. It is uncommon for medical technology firms to manufacture products that impact only 4,000 people or less annually in the United States.

To make devices for a market this small, companies would have to file for a humanitarian device exemption through the FDA. The exemption requires that they prove the product is safe and that its benefit outweighs the risk of injury, however, companies don't have to show clinical evidence that the product is effective.

That concerns Public Citizen, which argues that companies shouldn't be able to profit without proving the legitimacy of the device.

Companies being able to profit from devices that concerned consumer advocacy group Public Citizen.

Medtronic said it supports changes that will strengthen a regulatory pathway for medical technologies to treat rare diseases and disorders. Medtronic produces five different products under the humanitarian device exemption.

"Last year, the FDA testified to Congress that there are an estimated 20 million Americans suffering from rare diseases," Medtronic said, adding reform of the pathway is "needed to address that health care challenge."

Wendy Lee • 612-673-1712

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