Federal Appellate Decision Involving Off-Label Drug Marketing Could Expand the Ability of Pharmacies to Market Compound Prescriptions

By Jonathan E. Levitt, Esq. and Jesse C. Dresser, Esq.

Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug.  The decision, United States v. Caronia, could dramatically expand the free-speech rights of pharmaceutical companies and compounding pharmacies alike.  Compound marketers could enjoy greater leeway to share unapproved information.

The case involved a pharmaceutical marketing representative, Alfred Caronia, who was an employee of Jazz Pharmaceuticals.  Jazz Pharmaceuticals manufactures Xyrem, a powerful central nervous system depressant used to treat narcolepsy patients who experience cataplexy (a condition associated with weak or paralyzed muscles) and excessive daytime sleepiness (EDS).  The FDA recorded Caronia marketing the drug for off label uses.  He stated to a physician that, in addition to cataplexy and EDS, Xyrem could be used to treat insomnia, Fibromyalgia, periodic leg movement, restless leg syndrome, MS, Parkinson’s disease and other sleep disorders.  Caronia additionally marketed the drug to treat patients under the age of 16 (despite the fact that the Xyrem had only been approved by the FDA to treat patients over the age of 16). 

Caronia was convicted of violating Sections 331(a) and 333(a)(1) of the Food, Drug and Cosmetic Act (FDCA).  In those sections, the FDA prohibits the introduction of a misbranded drug into interstate commerce.  He was sentenced to one year’s probation.  Caronia appealed the conviction to the Second Circuit.

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