U.S. Sen. Paul Wellstone says he's working on legislation that would speed up the FDA approval process for medical devices. Wellstone and Connecticut Sen. Christopher Dodd held a forum on the issue Monday at Medtronic, Minnesota's largest medical device company.
Minnesota leads the nation in developing and manufacturing medical devices, with about 800 companies registered in the state. The largest by far is Medtronic, with 28,000 employees worldwide.
At Medtronic's brand-new corporate headquarters in Fridley, CEO Art Collins showed Wellstone and Dodd some of the latest technology to regulate the heartbeat. Collins held an implantable defibrillator in the palm of his hand. It's a silver device smaller than a business card.
"This is the Jem 3DR. Vice President Cheney has this device," Collins explained. "If you went back eight or nine years, this device was about five times the size, it was implanted down in the gut, you had to tunnel the leads up to the heart, and you had to have open heart surgery."
Collins also showed the senators the latest technology for people with diabetes, a pump that gives diabetics a constant flow of insulin. He told the story of a 10-year-old girl who loves the insulin pump.
"I said, 'Tell me about your pump and how it's changed your life.' And she said, 'I don't need to take shots any more.' And you know what else she said? 'I can have mud pie at my birthday party.'"
Collins says two-thirds of Medtronic's revenues last year came from products that weren't on the market two years ago. But the average time to get FDA approval for new devices has increased to nearly a year.
Wellstone and Dodd support requiring companies seeking FDA approval to pay a user fee that would allow the FDA to add staff. Pharmaceutical companies already pay a user fee, and Wellstone says the review time for new prescription drugs is shorter. However, a spokeswoman for the FDA says the average review time for new drugs is 12 months - about the same as the review time for medical devices.
Wellstone says he and Dodd are trying to find a compromise that also protects consumers.
"You don't want a product out on the market that's unsafe," says Wellstone. "But the other thing is, you don't want to have a product that could help someone - could literally save lives - but it's delayed and delayed and delayed because FDA doesn't have the resources."
Smaller companies are worried about the cost of a user fee. At a forum with other members of the medical device industry, the president of a small cardiovascular company said he worried about the burden such a user fee would impose. He said his product has been approved for two years in Europe, but has yet to get FDA approval.
Wellstone says lawmakers working on FDA reform legislation are looking at a first-year exemption for smaller companies. Medtronic CEO Collins says the medical device industry has been working with the FDA to come up with a fee the industry can live with.
"You look at the cost every year of being off the market. I think that you'll find out that these fees - with proper performance criteria - will end up to be economically beneficial for the small companies, but more importantly, to the patients that are not getting the access to the technology that, for example, in your case, the Europeans are," said Collins.
Sen. Dodd says the challenge will be putting together an FDA reform package before the end of this congressional session, since there are fewer than 40 working days before the November election.More Information