4 ms·
The FDA and USDA come to mind as institutions with a lot of questionable health policies. "To obtain permission to market a drug, the manufacturer must satisfy
by ramblenode 9y ago
The FDA and USDA come to mind as institutions with a lot of questionable health policies.
"To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not.
In addition, because FDA approval is mandatory, industry and medicine must heed FDA standards regardless of their relevance, efficiency, and appropriateness. Not all testing is equally beneficial. The FDA apparatus mandates testing that, in some cases, is not useful or not appropriately designed. The case against the FDA is not that premarket testing is unnecessary but that the costs and benefits of premarket testing would be better evaluated and the trade-offs better navigated in a voluntary, competitive system of drug development.
Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits."
http://www.fdareview.org/05_harm.php http://www.fdareview.org/05_harm.php
This may not be the most neutral source, but it at least raises some interesting points.
- jadedhacker 9y agoThis is not a specific criticism of a regulation that would meet the standard of removing regulations that would not produce harmful effects, it is a blanket criticism that dismisses the reason why the regulations exist at all. Yes, moving more quickly would save more lives... but at what expense? That expense would be more human lives diminished by medical experimentation. Perhaps those patients would accept that cost if there were a possibility of life saving drugs being more rapidly discovered. In that case, we have to ask, what is the likely actual result of revoking regulations? Most of those regulations are written in blood. This broad critique that doesn't specifically analyze a particular regulation is dangerous, because it neglects the role of the profit motive. Profit motive results in the externalization of costs to acquire more money. In general this results in snake oil, addictive medicines, wars, and ruined bodies. It also results in processes being cost optimized, though often the costs are simply externalized by the corporation, cheating, rather than making real progress. I strongly suspect that taking the leash off the corporate drug makers and researchers will result in an increase in human misery, rather than a reduction. A non-profit with secure (i.e. public) funding might be more well equipped to use their good sense in the absence of some regulations. I'll grant there may be some unproductive regulations, but the argument must be specific and evidence based rather than a generic broadside at all of them.
- omarforgotpwd 9y agoI doubt the FDA is a net killer of people. I'm sure many people die while waiting for the FDA to approve new drugs but many more people would also die, become sick, or have adverse effects if there were no standards. Furthermore the standards the FDA sets for things you put in your body creates the confidence that allows this market to exist in the first place. In a market without the FDA drugs would hit the market faster and be cheaper but still reach far fewer people because public weariness of these products would be too high, and there would be far too many products claiming to do the same thing making it difficult for consumers and doctors to find the most effective treatments. Are FDA regulations 100% optimized? No, I'm sure it's a bureaucratic nightmare. But at this point the best thing we can do is try and further optimize these regulations -- throwing them out completely isn't really an option.