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Also: http://fdareview.org/ http://fdareview.org/ "Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administrat

Also: http://fdareview.org/ http://fdareview.org/ "Medical drugs and devices cannot be marketed in the United States unless the U. S. Food and Drug Administration (FDA) grants specific approval. We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits. We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality. A large body of academic research has investigated the FDA and with unusual consensus has reached the same conclusion. Drawing on this body of research, we evaluate the costs and benefits of FDA policy. We also present a detailed history of the FDA, a review of the major plans for FDA reform, a glossary of terms, a collection of quotes from economists who have studied the FDA, and a reference section with many webbed links. A more detailed table of contents follows. We are happy to receive comments and criticisms."

kefka 11y ago
Yes, and bureaucracy never petitions for less bureaucracy. Only more. And we see this in multiple areas, and not just the FDA. FDA bureaucracy equals more people dying because of slowness. FCC bureaucracy equals regressive rules on radio transmitters and receivers, contrary to what the people in the field actually use/do. FAA bureaucracy leads to idiotic laws on quadcopters/drones/personal UAVS that affect the landscape of the technology to the point where uploading a video to youtube is "against the law". Patent law/USPTO bureaucracy leads to inane patents like XOR patent, "Slide to Unlock", fillet and round design patents (patent a 1/4 circle), One-click, and other patents that are glaringly obvious to anyone in the field. Yet, these enact heavy transaction fees; that is if the companies play along.
jcranmer 11y ago
I'm wary of relying on economists to assess the utility of the FDA. The alternative to the FDA they mention is basically self-policing. Except we already have a drug-like industry that relies entirely on self-policing: the "health supplements" industry, which the FDA is explicitly banned by legislation from regulating. And the precedent of the health supplements industry is extremely disconcerting--companies are basically legally lying through their teeth (it's not illegal if someone else, e.g., Dr. Oz, says it, cause they aren't advertising, they're exercising free speech), and they sometimes don't even bother to stuff their products with what they say the active ingredient is. The problem with drugs is the placebo effect. Evidencing efficacy beyond the placebo effect requires large, controlled trials (the infamous Phase III clinical trial) that end up being correspondingly expensive; nothing less is sufficiently powerful. Because of placebos, you can sell expensive nothings, and it will appear to work sufficiently well that reputation wouldn't suffer.

kefka 11y ago

Yes, and bureaucracy never petitions for less bureaucracy. Only more. And we see this in multiple areas, and not just the FDA. FDA bureaucracy equals more people dying because of slowness. FCC bureaucracy equals regressive rules on radio transmitters and receivers, contrary to what the people in the field actually use/do. FAA bureaucracy leads to idiotic laws on quadcopters/drones/personal UAVS that affect the landscape of the technology to the point where uploading a video to youtube is "against the law". Patent law/USPTO bureaucracy leads to inane patents like XOR patent, "Slide to Unlock", fillet and round design patents (patent a 1/4 circle), One-click, and other patents that are glaringly obvious to anyone in the field. Yet, these enact heavy transaction fees; that is if the companies play along.

jcranmer 11y ago

I'm wary of relying on economists to assess the utility of the FDA. The alternative to the FDA they mention is basically self-policing. Except we already have a drug-like industry that relies entirely on self-policing: the "health supplements" industry, which the FDA is explicitly banned by legislation from regulating. And the precedent of the health supplements industry is extremely disconcerting--companies are basically legally lying through their teeth (it's not illegal if someone else, e.g., Dr. Oz, says it, cause they aren't advertising, they're exercising free speech), and they sometimes don't even bother to stuff their products with what they say the active ingredient is. The problem with drugs is the placebo effect. Evidencing efficacy beyond the placebo effect requires large, controlled trials (the infamous Phase III clinical trial) that end up being correspondingly expensive; nothing less is sufficiently powerful. Because of placebos, you can sell expensive nothings, and it will appear to work sufficiently well that reputation wouldn't suffer.