Hydroxychloroquine vs. REGN-COV2
If you have COVID-19, your doctor can prescribe for you hydroxychloroquine. Its only FDA-authorized use is for malaria, and the FDA has cautioned against the use of hydroxychloroquine for COVID-19. But it’s up to you and your doctor, whose only legal worry should be the prospect of malpractice liability.
As of this writing, your doctor cannot prescribe for you REGN-COV2 (though Trump has promised to issue an Emergency Use Authorization). That’s the antibody treatment that President Trump received. Preliminary data suggests that this drug is promising. Another antibody treatment has produced even more promising though still preliminary results, but you can’t yet get that one either.
What accounts for the asymmetric treatment of hydroxychloroquine and REGN-COV2? Hydroxychloroquine is approved to treat malaria, and in the United States, once a drug is approved, doctors may prescribe it off-label for other uses. Doctors are advised to weigh the risks and benefits of off-label uses, but the matter is ultimately left in their discretion. Some commentators have observed that much off-label use is not based on scientific evidence and others have called for government regulation to quantify risks and benefits of off-label use. Yet another says that off-label use “is the death of the idea of regulation.”
But the idea of regulation is alive and well. We still prevent pharmaceutical companies from selling drugs like REGN-COV2, which have not been established to be safe and effective for any use (but which a rational doctor might well prescribe in some cases). One argument in defense of this regime is that once a drug is approved, it has been established that it is safe, so there is no harm from off-label use. But that can’t be quite right. The FDA compares the costs and benefits of a drug. That cost-benefit analysis will focus especially on the condition for which the drug is approved. Just because the drug is safe enough to be used for
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