FDA faulted for failure to track safety issues with drugs already on market

By Sheila Kaplan, STAT
January 14, 2016

WASHINGTON — Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.

On Thursday, however, a federal watchdog agency said the FDA is failing to sufficiently track and publicly disclose instances in such cases.

The Government Accountability Office investigation, conducted at the request of Representative Rosa DeLauro (D-Conn.), raises deep concerns about the FDA’s oversight. It expresses particular concern about the lack of tracking of drugs cleared under two expedited approval programs, which account for about one-quarter of all medicines permitted to go on the market.

“FDA has acknowledged that expediting drug application approvals can pose risks for patients,” GAO investigators wrote, stressing that “postmarket” monitoring for those drugs was especially important.

The investigators also criticized the FDA for failing to post quarterly reports listing certain potential safety issues that it has identified. Despite a statutory requirement that it do so, last year FDA posted no reports at all in its tracking system.


Diana Zuckerman, president of the National Center for Health Research, agreed the FDA needs to do a better job of monitoring safety issues with drugs that received expedited approval.

“All the pressure now within the FDA, and from patients and Congress is, ‘Let’s get drugs on the market more quickly. Let’s get those cures available to the people who want them more quickly.’ And the FDA has been doing that,” Zuckerman said.

On other hand, she said, the agency also needs to “make sure that better studies are done to see exactly who is likely to benefit and who is likely to be harmed.”

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