Abolish the FDA
Allegations are swirling that the FDA is doing a poor job protecting Americans from unsafe drugs.
Where to begin?
First and most obviously: why would anyone seriously expect taxpayer-funded bureaucrats to promote the well-being of consumers? These bureaucrats have no motive of personal gain (profit) or loss to inspire them to be diligent and creative in anticipating and serving the desires of millions of strangers. Furthermore, the FDA faces no real competition. Combine these facts with the additional reality that the regulated too often enjoy undue, if sub rosa, influence with the regulators -- thus "capturing" the regulatory process -- and you have a stew that is a hearty meal for bureaucrats, politicians, and regulated firms but that is poisonous to consumers.
Second and, in my opinion, even more importantly: the entire notion of "safe" and "unsafe" drugs is wrong.
Popular discussion of the FDA's role proceeds as if there is an objective level of safety for drugs. Each drug either reaches this level or it doesn't. If it does, it is "safe"; if it doesn't reach this level, it is "unsafe."
This notion is preposterous. The safety of each and every drug is in a range. Drug A can be more safe or less safe than can drug B. Modifications can make drug A more safe today than it was yesterday. Also, because different people often react differently to any drug, the safety of drug A to Ms. Jones might differ from the safety of the very same drug to Mr. Smith.
Apart from the benchmark of absolute, 100% safety for every potential user of any drug -- a benchmark impossible to attain -- there is no obvious benchmark (short of 100% safety for everyone) that distinguishes a "safe" drug from an "unsafe" drug. The FDA and pundits do the public no favors by prattling on as if it were otherwise.
Once we understand that absolute safety is impossible, we're closer to understanding that the FDA's ostensible goal of ensuring "safe" drugs is indefinable. Is it startling that a taxpayer-funded, centralized, monopoly bureaucracy -- charged with protecting 300 million people from "unsafe" drugs -- and overseen by politicians whose comparative advantage is in posing pretty for cameras and belting out platitudinous sound-bites, will screw-up given that the benchmark to which its performance is judged in fact is fundamentally indefinable?
Not only does the FDA not serve a valid public service; it cannot possibly serve a valid public service. It should be abolished immediately.
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Comments
So what do you propose? Strychnine in the aspirin? Placebos taking the majority of the market share? 100% deregulation? Not smart.
You are within your rights to claim there's something wrong with the system, but without a suggestion for improvement, it just sounds like whining.
Posted by: Anonymous | November 19, 2004 9:50 PM
While the utopist in me might want to agree, there's a reason why the term "snake oil salesman" has remained in our vernacular but not in our markets, and that reason is the FDA. The FDA can, ideally, at least serve as a efficient clearinghouse for clinical trial data that would keep scam products off the market. The sad part is that this is exactly what the FDA is not doing (e.g., the whole "nutraceutical" nonsense).
Another part of your post is also misleading: "the FDA faces no real competition." Of course it does -- Europe, Canada, etc. Before Vioxx, the main criticism of the FDA was one of timeliness -- it was delaying U.S. approval of drugs that were already cleared in Europe and elsewhere. But "inefficient" is not the same as "cannot possibly serve a valid public purpose."
Never let the perfect be the enemy of the good.
Posted by: KipEsquire | November 20, 2004 9:39 AM
I agree that it is unclear what the Purpose of the FDA is. Just look at Vioxx. The FDA said it was "safe and effective". After that the Manufacturer discovered that long term exposure increaed the risk of heart attack and they withdrew it. The FDA added nothing to the mix. The FDA is not protecting the public and the FDA is not assuming liability for those things it approves so what is the value add. It seems to me that a "truth will set you free" rule would serve the same purpose as the FDA. If the manufacturer tells the public/doctors every thing you know about the drug they are marketing (web sites are cheap), as long as the information is true and complete, they are immune for liability. If they mislead the public, either through commission or ommission (lie or withhold facts) they are liable. The FDA was needed when the flow of information was difficult, it is not difficult now. Incent the industry to be honest and the free market place (of products and ideas works)
Posted by: Chris | November 20, 2004 11:21 AM