Pharmaceutical Manufacturers Can Tout Off-Label Uses of Prescription Drugs

In the United States District Court for the Eastern District of New York, pharmaceutical sales representative Alfred Caronia was convicted of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor. Specifically, Caronia promoted an "off-label use" of a prescription drug for a purpose not approved by the U.S. Food and Drug Administration ("FDA"). However, Caronia appealed on the basis that he was convicted for his speech-for promoting an FDA-approved drug for off-label use-in violation of his free speech rights under the First Amendment. In December, the Second Circuit Court of appeals agreed and vacated the conviction.

The drug at issue was Xyrem, a powerful central nervous system depressant whose active ingredient has been federally classified as a "date rape drug." Xyrem was FDA approved for certain symptoms associated with narcolepsy. Caronia was recorded touting the benefits of Xyrem for restless legs syndrome and other sleep disorders, including for patients under sixteen years old. Caronia was convicted in 2008 but appealed.

The basis of the appeal was the First Amendment does not permit criminalizing a pharmaceutical manufacturer's truthful and non-misleading promotion of an FDA-approved drug to physicians for off-label use where such use is not itself illegal. The Second Circuit applied the Central Hudson commercial speech test and found that, while the government has an interest in regulating the use of prescription drugs, its prosecution of Caronia was not narrowly drawn and did not directly advance its legitimate goals.

The Second Circuit wrote, "our conclusion is limited to FDA-approved drugs for which off-label use is not prohibited... We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.

Take away: once the FDA approves a prescription drug, it can be prescribed by doctors for both FDA-approved and FDA-unapproved uses unless an off-label use is explicitly prohibited. The FDA generally does not regulate how physicians use approved drugs.

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