The FDA is unreliable – so let’s not rely on it

A new report reveals that as many as a third of all drugs approved by the Food and Drug Administration may have previously unknown safety risks. It’s undeniably worrying that so many pharmaceuticals are more dangerous than we thought, and there are doubtless many who will use this report as a justification for more restrictive approval policies at the FDA. But is that the right response?

What the report really shows is the danger of relying on a central authority, a government agency, to tell us what is safe and what is not. When you have an agency like the FDA giving an official government stamp of approval to pharmaceuticals, people tend to assume that adequate precautions have been taken and that they can trust the agency’s findings. In reality, there are no guarantees, and this is especially true in the case of bureaucrats who are unaccountable to the public.

The FDA approval process absolves individual consumers, doctors, and the pharmaceutical companies themselves from responsibility for drug safety. Any of these people can point to the FDA seal of approval and say “See? It’s safe.” If it later turns out that there were hidden dangers, it’s easy to blame the FDA for not doing its job. This encourages complacency where there should be vigilance.

There’s also the problem that once a drug is approved by the FDA, that’s usually the end of the review process. There is generally no follow-up, even as scientific techniques advance. A more decentralized system that doesn’t rely on a single stamp of approval would be more robust and encourage continuing safety evaluations.

In a world without the FDA, responsibility for drug safety would fall on all of our shoulders. It would be up to doctors to ensure that drugs are safe before they prescribe them. It would be up to consumers to verify the safety of what they are taking. Watchdog groups would be more important, and their competition for accuracy would result in better information for consumers.

Economist F.A. Hayek wrote extensively about “the knowledge problem”. This is the idea that no one person, or one agency, can have enough knowledge about complex systems to organize them more effectively than the combined knowledge of millions of participants. Hayek was mainly talking about markets, but the same principle applies here. No one of us has as much knowledge as all of us put together. Removing drug safety from the exclusive control of government, and relying instead on the combined expertise of everyone involved in the decision-making process, would not only result in a more vigilant and cautious public, but would enable consumers to make better-informed decisions about their own health.

The widespread realization that the FDA is not only fallible, but downright unreliable, could be the best thing that ever happened to drug safety and personal health. Unfortunately, what we will likely get instead is a more restrictive system in which helpful drugs are denied to patients in need, over safety fears that may or may not be well founded.