Justices Must Resolve Off-Label Drug Warning Predicament

Law360 (May 10, 2021, 5:41 PM EDT) -- The U.S. Supreme Court will soon decide whether to hear a case, Janssen Pharmaceuticals Inc. v. AY, involving the off-label use of drugs approved by the U.S. Food and Drug Administration.

This case has wide-ranging implications for the practice of medicine, drug-pricing and, more importantly, patient access to medically necessary and often lifesaving therapies.

In the U.S., physicians may lawfully administer and prescribe FDA-approved drugs for off-label uses — i.e., uses that are not included in the drug's FDA-approved label. The practice, which accounts for roughly 20% of all prescriptions, is both common and critical to the public health.

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