The New York Times ran an article on Saturday on a reported written on the state of the FDA by 3 members of the F.D.A. Science Board. According to the article, the report concludes that:
over the last two decades, the agency’s public health responsibilities have soared while its appropriations have barely budged. The result is that the F.D.A. is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.
“F.D.A.’s inability to keep up with scientific advances means that American lives are at risk,” the report stated.
Other excerpts from the report were:
- “Reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still handwritten 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”
- “F.D.A.’s ability to provide its basic food system inspection, enforcement and rule-making functions is severely eroded, as is its ability to respond to outbreaks in a timely manner.”
It is hardly surprising that the FDA cannot do its many vital jobs, given the inadequacy of the appropriations it receives every year. The FDA is responsible for regulating the safety of our food supply, and of the drugs and medical devices used to protect health and cure illness. It should have funding that is robust enough to allow it adequately protect the public from unsafe food and drugs, but does not.
The FDA’s review of new drugs is now funded by the very drug companies who stand to profit when those drugs are approved. The more drugs reviewed and the faster they are approved, the more funding the FDA receives from drug company “user fees.” The agency, like so many federal agencies, has a constantly-spinning revolving door between itself and the industries it regulates, so much so that its decisions seem geared more towards protecting those industries than protecting the public.
Short-changing the FDA is the ultimate in “penny-wise, pound-foolish” thinking. Every new crisis in food safety or drug dangers briefly raises the public’s awareness of and concern for the FDA and its ability to do its job, but the underlying crisis with the FDA soon fades from public consciousness. What we need is for the public to pressure Congress to take the FDA and its incredibly important roles seriously, and ensure that it has adequate funding not just now, but for the long haul. But funding does not necessarily equal good monitoring and enforcement. We need leadership at the FDA that is willing to take on and challenge the industries that it regulates, and that don’t just act as industry’s rubber stamp.
Until that happens, the next catastrophe will always loom just around the corner.