
The Food and Drug Administration (FDA) Science Board's Subcommittee on Science and Technology released a very worrying report late last week on the current state of science and technology at the FDA:
"The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities."
According to the FDA, it is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nationâ''s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
As the Subcommittee points out in its report,"The nation is at risk if FDA science is at risk."
In addition to the scientific deficiencies, another one of the critical findings of the Subcommittee's report is that, "The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate."
The report notes:
The Subcommittee was extremely disturbed at the state of the FDA IT infrastructure. While some good progress is being made to improve information sciences and technology, the Subcommittee found that the FDA lacks the IT infrastructure necessary to meet its mandate. It also found that the FDA has insufficient access to data and cannot effectively regulate products based on new science due to lack of a supportive IT infrastructure. The Subcommittee noted that the FDA IT infrastructure is obsolete, unstable and lacks controls to execute effective disaster recovery protocols that ensure continuity of operations when systems are compromised. Finally, the IT workforce is insufficient."
The report notes that FDA IT systems fail frequently, and even email systems are unstable. The report goes on: "More importantly, reports of product dangers are not rapidly compared and analyzed, inspectorsâ'' reports are still hand written and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt)."
I urge you to read the report; it makes for some very sad as well as scary reading.
What's par for the course these days in Washington, but is still depressing nevertheless is that the Subcommittee blames Congress for insufficiently funding the FDA while asking it to do more, while Congress says the FDA hasn't been asking for more money because the current Administration wants less government regulation of business and more "market-based regulation."
The truth is a bit of both, which means a standoff and so science and technology at the FDA languish. Even where there is agreement between Congress and the Administration over the necessity some of the FDA's missions, the FDA is no longer able perform these well if at all.
A sorry state of affairs, indeed.
I guess we'll all just have to be a little more cautious when we eat, or take medicines, or use medical devices, or apply cosmetics, or are near products that emit radiation.