Paul Davis
2 min readMay 6, 2019

Speaking of basing things on hard evidence, how about applying an evidence-based analysis of the costs vs. benefits of FDA oversight. The FDA does this itself, as mandated by law, but, as you would expect, they find that their actions are always justified.

An external audit would likely come to far different conclusions. For example, an article last year in STAT magazine highlighted the case of a woman who has been receiving affordable and efficacious treatment for years for Lambert-Eaton Myasthenic Syndrome using the non-FDA-approved drug 3,4-DAP. But with FDA approval the drug will likely cost her anywhere from $100,000 to $300,000 a year.

If you start digging into any of the recent drug pricing scandals, the FDA approval process is almost always involved, either as a direct cost component or by the way it concentrates pricing power into the hands of the few companies big enough to pay their way through the FDA approval maze.

Second, there is the matter of consumer consciousness. Having been assured that Uncle is taking care of things for them, consumers offload what should be their own due diligence to the Federal government. In a perverse way, this probably accounts for much of the public’s gullibility in purchasing supplements. Even though supplements aren’t FDA-regulated, the public has become so accustomed to having had everything studied and approved by someone else that they don’t give much thought to the points you mention … overdoses and interactions or even tainted products.

Further, there is the matter of accountability. As a governmental agency, it can’t be held legally accountable for its decisions. So if it makes a wrong call or a late call, no one has to take the blame. Politico had an article last year discussing one of those disasters.

Instead of expanding the rubric of the FDA and compounding the weaknesses it brings to the markets it oversees, a sensible direction would be to make the FDA advisory only, much like the Underwriter’s Laboratories approval stamp on appliances. If people wanted to buy only FDA-approved drugs they could look for the stamp; if they didn’t care, they would be free to act accordingly.

Meanwhile, other organizations might arise and step in with their own testing labs and approval stamps so that when FDA made a mistake it would be clear, and people would start demanding more reliable approvals on the products they considered.

An organization called Downsizedc.org has a proposal to do that very thing.

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Paul Davis
Paul Davis

Written by Paul Davis

Nomadic writer, realist, voluntaryist, nudist, singer, drummer, harmonica and recorder player, composer, gadfly, runner, troublemaker, survivor so far.

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