WASHINGTON—Outgoing Food and Drug Administration Commissioner Margaret Hamburg, in what she said was her final public address in the post, expressed serious concerns about patient harm that could occur because of the 21st Century Cures Act circulating on Capitol Hill.
The 393-page bill, released in draft form Jan. 27, would have wide-ranging impacts. It would, for example, speed 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 Friday at a National Press Club luncheon.
She also is concerned that the legislation, if enacted, would spread the FDA's 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 announced last month that she would step down in March.
“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.”