Loosening a logjam on med-tech approvals

When it comes to medical devices, Minnesota is a Little Silicon Valley on the Prairie. It's home to more than 350 medical technology companies that employ more than 35,000 people; what happens in the halls of Washington, D.C., reverberates here.

So when U.S. Sen. Al Franken invited FDA Commissioner Margaret Hamburg to meet with him, U.S. Sen. Amy Klobuchar and representatives of Minnesota's med-tech industry, it was another chance for them to tell the commissioner about the need to cut regulatory red tape and ease the path of devices to market.

Hamburg met with the Democratic senators and med-tech leaders behind closed doors at the U.S. Food and Drug Administration's downtown Minneapolis offices. Later, they emerged to say they'd shared ideas, thoughts and concerns about the direction of med-tech and what they say needs to be done to improve it.

Hamburg and the senators sounded an optimistic tone. Pointing to the FDA Safety and Innovation Act signed into law last month, Hamburg said the logjam for approving medical devices already is loosening.

"One reason I think it's going to change is we're starting to see change already," Hamburg said, adding that passage of the legislation -- which includes a new fee agreement between the medical technology industry and the FDA -- will give the agency additional resources and authority.

For instance, an additional 200 people will review and approve medical devices, she said. There also will be more resources for training reviewers and stronger management of the review process.

Folks inside the industry acknowledge the FDA often is caught between a rock, a hard place and an anvil -- trying to satisfy industry advocates and patient groups that think medical devices are approved too slowly, while some consumer groups and attorneys worry that devices are hitting the market without adequate vetting. Still others complain the FDA's oversight role does not have predictability and transparency.

But Franken and Klobuchar said the new law gives the FDA more funding and flexibility. The process of approving new devices also will be improved -- and shortened -- by loosening conflict-of-interest rules that will allow a greater number of outside scientists to be able to review proposed medical devices. They also touted a new initiative between the FDA and LifeScience Alley to work together to improve regulatory science.

Hamburg appears to have heard the message.

"This part of the world is terribly important to what's going on in medical innovation, particularly in the medical device area," she said. "This is sort of a critical moment, with the passage of the legislation."

But just two months ago, the people who lead Minnesota's medical-technology companies said in a survey that they see dark days ahead for their industry because of uncertainty and delays in winning government approval for new devices.

On Wednesday, after meeting with Hamburg, local attorney Mark DuVal said in an e-mail that the industry plans to file a petition asking her to review how the agency is operating today.

"While we are excited about the regulatory science initiative being undertaken by FDA and LifeScience Alley, it is likely that is five to six years away or more and there are thousands of medical device companies that must contend with the here and now," wrote DuVal, who works with companies appealing FDA decisions. "So our citizen petition will outline those issues we think need short-term work. We hope she will find it insightful and useful."

DuVal said in his e-mail that his group intends to conduct another survey in an effort to better inform federal officials about how the industry views the review and approval process.

After the meeting, Franken said he believes the government and the industry are finding common ground for a field of science that "saves so many lives and creates so many high-quality jobs."

Klobuchar agreed, saying it is possible to satisfy multiple groups when it comes to devices. "We are working to make sure patients are safe, but just that it goes faster and there's more consistency."

James Walsh • 612-673-7428