WASHINGTON – Six of Minnesota’s 10 members of Congress have signed a letter to the head of the Food and Drug Administration urging the agency to speed its approval process for medical devices.
“We urge you to make every possible improvement to cut down device approval times,” wrote the 41 lawmakers from both parties and both chambers of Congress who signed the letter. Minnesota’s signatories included DFL Sens. Amy Klobuchar and Al Franken, GOP Reps. Erik Paulsen, John Kline and Michele Bachmann and DFL Rep. Betty McCollum.
The time it takes the FDA to approve new medical devices has increased over the past decade, worrying many in the industry that the regulatory process is stifling innovation. Minnesota is home to hundreds of medical device companies, including Medtronic and St. Jude Medical, as well as smaller venture capital-funded start ups.
The lawmakers and industry backers point to the medical device field as an area where American firms have a competitive advantage over foreign companies in export markets and also note that jobs in the sector have much higher than average salaries.
Klobuchar and Paulsen have recently introduced legislation that is intended to speed up the agency’s device approval process and this letter contains some suggestions drawn from both lawmakers’ bills, such as changing the FDA’s conflict of interest rules for doctors sitting on advisory panels, as well as new elements such as considering harmonizing the FDA’s approval process with foreign regulators.
In an interview with MPR News last month, Diana Zuckerman of the National Research Center for Women and Families criticized Klobuchar and Paulsen’s legislation, arguing that a lack of resources at the FDA, rather than stifling bureaucracy, was behind the slowing approval times.
“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 [FDA] Center for Devices.”
Paulsen was also the subject of a front page story in the New York Times last month raising questions about political donations from venture capital firms that are pushing for faster FDA approval of medical devices.