WASHINGTON — Acorn Cardiovascular, a New Brighton-based medical technology company, had waited years for the Food and Drug Administration to approve its heart failure device. The wait was so long that it scared away investors, and the company soon didn’t have enough money to perform another trial on the device. Acorn, which had raised more than $100 million dollars since 2002, shut its doors last year.
The Food and Drug Administration is too slow and too inconsistent in approving medical devices for use on the market, Rep. Erik Paulsen said during testimony before a House panel Thursday. Using Acorn as an example, he warned that FDA policies have potentially dire side effects for American medical technology businesses, and he said he’ll soon propose legislation to change the approval process.
With more than 400 companies and 35,000 employees, Minnesota has one of the strongest medical device industries in the country, and lawmakers are quick to point to policies they support to uphold that. In Congress, Minnesotans Paulsen and Sen. Amy Klobuchar have played among the most vocal roles in supporting the industry.
Paulsen is the co-chair of the House Medical Technology Caucus, and Klobuchar is a founder of the Senate’s version. The two have teamed up to criticize FDA standards in the past, including a letter to FDA Commissioner Margaret Hamburg last year warning against policy changes that would create “new and unnecessary regulations, resulting in an even longer and more complicated approval process.”
Now Paulsen is planning to propose legislation that would “modernize and streamline” the FDA’s medical device approval process, though he was vague about what that legislation will look like.
“We’re putting some ideas together right now to streamline the FDA to make it a more predictable, transparent process,” he said after his testimony. “We’re looking at … not only the companies in the United States who have had to deal with a more frustrating FDA process, but also looking at the processes that are employed in Europe, for instance, and why they are approving devices two years quicker than the United States.”
Committee members used that line of reasoning when peppering the FDA’s Jeffrey Shuren with questions at the hearing. Shuren, the director of the FDA’s Center for Devices and Radiological Health, defended U.S. procedures for approving high-risk devices when compared to approval procedures in Europe, where he said there is a history of previously-approved devices turning out to be dangerous or ineffective once they are fully tested.
“The U.S. standard of approval is the robust standard that we should stand behind,” he said, but he echoed Paulsen when he acknowledged, “We just need to get behind it and make sure it is as predicable and efficient as it should be.”
Paulsen said he hopes his legislation, which he wants to propose before the August recess, will get bipartisan support, like that enjoyed by his plan to repeal a medical device tax.
Klobuchar’s office said she is not writing similar legislation right now. In the past, though, she and the Senate Medical Technology Caucus have called on the FDA to consider revising its medical device approval process, and has struck a tone similar to the one taken by Paulsen.
“[The] FDA should carefully consider the impact of any proposed [approval process] change on the ability of companies to innovate in a predictable and consistent regulatory environment so they can continue to bring medical advances to patients,” the caucus wrote in a December letter to the FDA.
A report from the Institute of Medicine outlining potential fixes for the medical device approval process is expected this summer.
Devin Henry is an intern in MinnPost’s Washington Bureau.