The medical device industry is an important employer in Minnesota that has a lot riding on events in Washington, DC, both at the Food and Drug Administration and in the halls of Congress. A Minnesota congressman has emerged as one of the industry's strongest backers in the nation's capital.
Rep. Erik Paulsen, R-Minn., tends to keep a low profile. But bring up the medical device industry and Paulsen becomes animated.
"Minnesota is the land of 10,000 lakes, but it's also the land of 400-plus medical device companies and 35,000-plus jobs."
Paulsen represents the 3rd Congressional District in the western Minneapolis suburbs where many of the people who do those jobs live. The industry has helped him become one of the strongest fundraisers from Minnesota's congressional delegation. Political action committees and individuals with ties to the device industry have given more than $150,000 to Paulsen's congressional campaign since 2008. Paulsen acknowledges that his support comes as the industry needs friends in Washington.
"There's not a voice, or too many strong voices, I should say, around this industry," he said.
The device industry wants to eliminate a provision in last year's health care law that puts a 2.3 percent tax on the industry's revenues. The tax is supposed to raise $20 billion over the next decade to go toward paying for the health care bill.
Paulsen introduced a bill to repeal the tax, but with the Senate and White House in Democratic hands, the measure hasn't gone very far.
The industry also wants speedier FDA approval for bringing new devices to the market. Paulsen and the industry use the same talking points about quickening the approval process. They argue that the U.S. has a technological lead that it risks losing.
"The investment companies are starting to move all their products and innovations in Europe, for instance, and we should own this and keep it in the United States," Paulsen said. "That's why I'm very passionate it about it."
Both Paulsen and DFL Sen. Amy Klobuchar have introduced legislation to speed up the FDA's approval process of medical devices. But a series of high-profile recalls after devices harmed some patients is one reason the process has slowed.
Earlier this year, Diana Zuckerman, president of the National Research Center for Women and Families, published a peer-reviewed study in the Archives of Internal Medicine of medical devices recalled by the FDA because they could cause serious injury or death. The study found that most of the devices recalled were approved under the same process for medical devices that Paulsen and Klobuchar want to speed up.
After some of those recalls, the FDA has emphasized safety rather than speed, Zuckerman said. She said the agency, which relies on industry user fees, doesn't have the money to speed up the approval process.
"This legislation is not the answer for faster reviews," Zuckerman said. "If they want good, fast reviews, they should be willing to pay larger user fees or the Republican Congress should be willing to increase the appropriation for the Center for Devices."
Both Paulsen and Klobuchar insist that safety won't be compromised, and that their bills will maintain the FDA's high standards for approval.
This measure is the first of several FDA bills Paulsen is working on, he said, and the House Republican leadership has given him an unusual amount of influence in drafting the legislation.
Paulsen is confident that some of his proposals will make it through Congress by next year.
"I think we're going to have the opportunity to merge some proposals together in making sure the FDA is responsive to some of the concerns that have been raised," he said.
Paulsen's bill would also require the FDA to give companies more feedback when a device is not approved.