21st Century Cures Act would lower ‘safety standards,’ Hamburg warns
WASHINGTON—Outgoing Food and Drug Administration Commissioner Dr. Margaret Hamburg, in what was likely her final public address as commissioner last Friday, raised serious concerns about possible patient harm that could occur as the result of the 21st Century Cures Act now circulating on Capitol Hill.
The 393-page bill, released in draft form Jan. 27, would, if enacted, have wide-ranging impacts, including speeding up the approval pathway for medical technologies and drugs, in part, by allowing for more “flexible” clinical trial design.
“There’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well,” Hamburg said at a National Press Club luncheon. The often cashstrapped agency also has concerns that enactment of the law will spread its already thin resources even thinner.
“We are concerned through this process that we might be ... asked to take on new tasks (and) that we wouldn’t have the adequate resources to do them,” Hamburg said. “This would have ripple effects on other important regulatory activities that really matter to patients and consumers.”
Hamburg has been leading the FDA for the past six years and is stepping down at the end of the month.
“As I look forward, I worry,” she said. “FDA has constantly been underfunded with responsibilities that outstrip the resources we get to do our job.”