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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.


General Accountability Office report on drug safety

“The GAO report confirms my greatest fear, that FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective,” DeLauro said in a statement. “If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of post market studies are absolutely vital.”

FDA spokesman Christopher Kelly said that the agency’s Center for Drug Evaluation and Research is currently taking steps to retroactively enter the information about significant postmarket safety issues into its tracking system and to update its quarterly reports.

In a statement, Kelly said the FDA had issued public advisories or other warnings in most cases in which drugs showed signs of serious risk. He could not provide a list of which drugs, or how many, fell into that category.

“Staff have prioritized the work of fully addressing and resolving important public health issues over completely adhering to the time-consuming data entry procedures of tracking safety issues,” Kelly said.

The GAO, however, suggested the failures were indicative of broader issues.

“FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight,” investigators wrote.

Investigators said the FDA’s database had inaccurate and incomplete data. They also said that the data on hand were not readily accessible in a form that the staff could use for analysis.

The backlog of postmarket data has been a recurring problem at the FDA. A contractor hired in 2008 found more than 500 postmarket studies had been submitted but not reviewed by FDA staff. GAO now cites a similar problem, with more than half of the reviews of sponsors’ submissions associated with about 1,400 postmarket studies delayed or overdue.

Washington attorney Reuben Guttman, who has represented whistleblowers in some of the largest cases against pharmaceutical companies, said he was not surprised to learn of the GAO’s findings.

“Of course this shows a major gap in regulatory oversight,” said Guttman. “We never want to expose people to risk and we never want our health care system to bear the cost of treating injury.”

Guttman said he was especially concerned by the GAO’s findings about the FDA’s failure to sufficiently monitor issues with drugs that were granted expedited approval, many of which are cancer treatments.

“Unfortunately, particularly in the area of cancer drugs, a major issue will be side effects, and many patients die from the treatment and not directly from the disease,” Guttman said. “It’s important to be diligent about postmarketing studies, which can provide information to prevent harm.”

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.”