Monday, May 08, 2017

The Dangers of the FDA's Regulatory Hegemony

Courts rule against it yet the FDA fights for bureacratic meddling anyway

In March, Arizona became the first state to pass a bill allowing the free flow of medical information between drug companies and physicians. The Free Speech in Medicine Act, which was passed unanimously in both state houses, may seem curiously innocuous: It simply permits pharmaceutical companies to share information with licensed health-care professionals, provided the information is not misleading, not contrary to fact, and consistent with generally accepted scientific principles. So far, so good—one might rightly assume that relaying information would be permissible with or without legislation.

However, FDA regulations largely prohibit pharmaceutical companies from discussing safe and effective uses for FDA-approved drugs, unless those uses have been specifically sanctioned by the agency. For example, if the FDA approved a certain drug as a headache treatment, drug company representatives could not recommend that drug as a treatment for muscle pain, even if substantive data showed that it treats muscle pain effectively. Instead, the company would need to apply and pay for a separate FDA trial to approve that use. In practice, this means that information on effective treatments is often deliberately concealed from doctors, despite the fact that they are free to prescribe FDA-approved medicines for virtually any purpose they see fit.

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