Epstein on Legal Issues Around Off-Label Drug Uses

Memo to SCOTUS: Cut the FDA Down to Size

The law has long been of two minds about the power of the Food and Drug Administration (FDA) to regulate the off-label use of drugs that it approves for sale. Today the FDA has the unquestioned power to limit the uses for which a drug may be sold to those uses approved by the FDA after a rigorous and costly review process. By the same token, the FDA is prohibited by statute from interfering with the practice of medicine. Doctors, therefore, may exercise their professional judgment and prescribe any FDA-approved drug for unapproved or “off-label” use.

This dual regime makes little sense. If FDA approval is so important, why allow physicians to prescribe a drug for an unapproved use, ever? Alternatively, if physicians may prescribe drugs for conditions that have not been reviewed by the FDA, why allow the FDA to block drugs from physician-prescribed use in the first place?

The current law ducks this tension with an inelegant compromise. Physicians may go their own way in prescribing drugs for off-label uses; indeed, the appropriate standard of care in medical malpractice cases may require the off-label use of an approved drug. Yet, drug companies and their sales agents are not allowed to promote the drugs for off-label uses. If they do, the FDA imposes heavy criminal sanctions on them.

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