FDA’s Plans To Speed Medical-Device Approval Process Has Some On Edge Over Patient Safety
Doctors are also worried about the lack of oversight after the product gets to the market. "The [Food and Drug Administration’s] track record on post-market surveillance is not reassuring, most post-marketing studies are not started or not completed, and the data remains unavailable to clinicians and patients," said Rita F. Redberg, editor of JAMA Internal Medicine.
The Wall Street Journal:
FDA Plans New Medical-Device Approval Processes
The Food and Drug Administration plans new medical-device approval processes to speed products’ entry to the U.S. market, mirroring the desires of industry and President Donald Trump to clear barriers to new business. FDA commissioner Scott Gottlieb, who has long espoused speedier steps to promote innovation, in an interview called for “progressive,” or stepped, approvals of certain devices that would allow them to go to market with initial approvals, with further evidence to assess performance coming later. That would entail more risk to patients initially than current procedures where clinical trials or other evidence come before market launch. (Burton, 12/11)
Device-Makers Hope Coverage Rule Promotes Fast Approvals
The medical device industry is pushing the Trump administration to propose a policy soon to expedite Medicare coverage of some new devices. But the attempt to get these products covered more quickly raises some safety concerns and follows another similar effort that some observers found disappointing. A proposed rule is currently under review at the Office of Management and Budget with the title “Expedited Coverage of Innovative Technology.” The proposal has been waiting at OMB since late April, but industry groups don’t think its publication is imminent. (Siddons, 12/11)