By James Walsh
Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, spent time in Minneapolis Wednesday morning meeting with Minnesota's two U.S. senators and representatives of the state's medical technology industry. The reason: To share ideas, thoughts and concerns about the direction of med tech in Minnesota and what stakeholders believe needs to be done at the federal level to improve it.
Many acknowledge that 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 and some consumer groups and attorneys who worry that devices are hitting the market without adequate safety vetting. Still others complain that the FDA's oversight role does not have predictability and transparency.
After their meeting with industry representatives, Hamburg and senators Al Franken and Amy Klobuchar sounded an optimistic tone, pointing to recent legislation that gives the FDA more funding and flexibility and a loosening of the logjam for medical device approvals.
"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 -- including a new fee agreement between the medical technology industry and the FDA -- will give the agency additional resources and authority.
For instance, more than 200 people will be added to the work of reviewing and approving medical devices, she said. There also will be more resources for training reviewers and stronger management of the review process.
Franken and Klobuchar said the process will also be improved -- and shortened -- by the loosening of conflict-of-interest rules that will allow a greater number of outside scientists to be able to review proposed medical devices.
"This part of the world is terribly important to what's going on in medical innovation, particularly in the medical device area," Hamburg said. "This is sort of a critical moment, with the passage of the legislation."
Franken said he believes the government and the industry can and 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."