The Food and Drug Administration has proposed a new way for breakthrough medical devices to be approved by the agency.
In a briefing Tuesday, agency officials said the new Innovation Pathway is part of an initiative designed to help cutting-edge products win quicker clearance -- a huge issue in Minnesota, home to more than 300 med-tech companies, including industry giant Medtronic Inc.
Many industry officials charge that the FDA's approval process is inefficient and unpredictable.
FDA device chief Dr. Jeffrey Shuren said the new pathway "isn't an ordinary proposal and not the usual from a regulatory agency." Noting the agency's approval process has historically been "reactive," Shuren characterized the new initiative as "a sea change in the way we approach public health."
Med-tech officials reacted cautiously to the FDA proposal Tuesday. Stephen Ubl, who heads the Washington, D.C.-based trade association AdvaMed, said it will "carefully review the specifics" of the initiative.
"We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process," said Ubl, a Minnesota native. The problems with the process "needlessly delay patient access to life-saving, life-enhancing medical technology," he added.
Steve Anderson, president of now-defunct Acorn Cardiovascular, said the med-tech industry needs "to see concrete progress at the reviewer level of the FDA, and not just at the policymaker level. To date, there is no indication of progress at that level within the agency."
New Brighton-based Acorn raised $110 million to develop a novel device to treat heart failure, but failed to gain FDA approval after a decade of wrangling with the agency.