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Off-Label Use Promotion is Protected Free Speech

By Robyn Hagan Cain | Last updated on

A recent Second Circuit Court of Appeals decision will make life a lot easier for pharmaceutical sales reps.

Monday, the appellate court ruled that a drug manufacturer's off-label use promotions are protected free speech, as long as such promotions are not false or misleading, Reuters reports.

Under the Federal Drug and Cosmetic Act (FDCA), drugs must be approved by the FDA for specific uses before they can be distributed into interstate commerce. To obtain FDA approval, drug manufacturers are required to demonstrate, through clinical trials, the safety and efficacy of a new drug for each intended use or indication.

Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and -unapproved uses; the FDA generally doesn't regulate how physicians use approved drugs. Both the courts and the FDA have recognized the propriety and potential public value of unapproved or off-label drug use.

On the other hand, pharmaceutical manufacturers and their representatives previously faced misdemeanor charges for misbranding or felony charges for fraudulently misbranding drugs.

The FDCA prohibits misbranding, and the introduction or delivery into interstate commerce of any drug that is misbranded. A drug is misbranded if its labeling fails to bear "adequate directions for use," which FDA defines as "directions under which a lay person can use a drug safely and for the purposes for which it is intended."

That means that doctors could prescribe a drug for off-label use, but drug reps couldn't promote a drug's off-label uses if the drug didn't bear adequate instructions for the use.

In October 2005, Alfred Caronia was convicted under the FDCA for conspiracy to introduce a misbranded drug into interstate commerce. He was sentenced to one year of probation, plus 100 hours of community service, for improperly promoting Xyrem, a narcolepsy drug, for "off-label" uses.

On appeal, Caronia argued that he was convicted for his speech -- promoting the off-label use of an approved prescription drug -- in violation of the First Amendment.

This week, a Second Circuit Court of Appeals panel vacated and remanded Caronia's conviction. The 2-1 majority reasoned, "In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed."

Thomas Liotti, a lawyer for Caronia, praised the decision, telling Reuters "If physicians can talk about alternative uses of drugs among themselves, it doesn't seem to make any sense that others cannot."

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