FDA's Hamburg: Device-approval process already improving

FDA Commissioner Margaret Hamburg said the recently passed user-fee reauthorization is already helping to quicken the pace for device approvals. Hamburg made that assertion after a sit-down with Minnesota senators and devicemakers, saying both sides walked away optimistic about the future.

Sens. Al Franken and Amy Klobuchar, both Minnesota Democrats, attended the meeting and said the FDA Safety and Innovation Act will give the agency more resources to vet and approve devices, Star Tribune reports. For one, the FDA will get 200 more reviewers at its disposal, and a loosening of conflict-of-interest regulations will allow the agency to use more outside scientists in the approval process, ideally speeding it up.

Those reforms don't come cheap, however, and the Safety and Innovation Act effectively doubles the cost devicemakers will pay for approvals over the next 5 years to $595 million. But industry groups, like the Medical Imaging & Technology Alliance and AdvaMed, have voiced their support of the fee hike because it comes with the FDA's promise to implement a more predictable, reliable, efficient and expeditious approval process for devices.

Good as all that sounds, it could be 5 or 6 years away, local attorney Mark DuVal told the newspaper. DuVal, who represents devicemakers appealing FDA decisions, said the industry plans to file a petition asking Hamburg to review how the FDA currently operates. Thousands of device companies are currently slogging through the approval process, DuVal told the paper, and the petition would ask the FDA to focus on short-term fixes as it prepares for broader changes.

In the meantime, Franken said he's confident devicemakers and regulators can find common ground, and Klobuchar noted the two parties have their work cut out for them: "We are working to make sure patients are safe, but just that it goes faster and there's more consistency," she said.

- read the Star Tribune report