Tech problems hamper drug agency, report says

Severe weaknesses in information technology are hampering the Food and Drug Administration's regulatory role, with some computer systems unable to distinguish between different forms of common chemical compounds like salt, an advisory panel said Monday.

"The IT situation at FDA is problematic at best -- and at worst it is dangerous," according to a report released by the FDA Science Board Advisory Committee.

Many systems are obsolete or failing, "and even e-mail systems are unstable," the report said. "Not surprisingly, it has been reported that during a 2007 E. coli outbreak due to contaminated spinach, the FDA's response was hampered by outages in its e-mail systems."

Inspectors' reports are still handwritten, and the system for managing imported products cannot communicate with Customs and Border Protection and other government systems, the report said. Regulators often miss important product arrivals because the systems cannot distinguish, for example, between road salt and table salt.

The committee issued the report detailing common, recurring gaps in the agency's science and technology that are interfering with the ability to regulate prescription drugs, medical devices and cosmetics, among other items. The evaluation marked only the second time FDA has been reviewed as a whole organization.

"The bottom line is that demands at FDA have soared, resources have not," said committee member Gail Cassell, Eli Lilly's vice president for scientific affairs. Those demands include the globalization of the industries that FDA regulates and the complexity of products submitted for approval.

Cassell said FDA regulates 25 cents of every consumer dollar spent in this country, or $1 trillion in consumer products, but Congress funded FDA at only $1.6 billion for fiscal 2007.

She noted that the report was not supposed to make recommendations about resources. "It is true we overstepped our charge and were forced to look at resources."

FDA data currently reside in large storage rooms "sequestered in piles and piles of paper documents," and there are no backup copies, according to the report.

Report co-author Dale Nordenberg, a former information management chief at the Centers for Disease Control and Prevention, said there has been "some important progress -- perhaps too slow -- by very competent people at the agency." Namely, he said, the new chief information, chief operating and chief technology officers have strong track records at other agencies.

"Investment in the IT arena would be capable of being managed at the FDA" and would strengthen the agency's ability to execute its regulatory mission, Nordenberg added.

The report also found FDA to be grossly understaffed. The committee recommended enlarging FDA's workforce and employing technology to reduce workloads.

For example, the FDA might want to place sensing devices at manufacturing plants, in rail cars, and on product packaging to detect purity and contamination. "The extraordinary number of sites that must be monitored and the dearth of inspectors translate into the FDA's inability to fulfill its quality assurance mandate," the report said.

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