Friday, January 25, 2013

Off label free speech contd.

U.S. won't pursue case of drug representative and 'off-label' promotion

David Sell, Inquirer Staff Writer

Posted: Friday, January 25, 2013, 3:01 AM
The federal government has decided not to ask the U.S. Supreme Court to overrule a recent appeals court decision that overturned the conviction of a pharmaceutical sales representative who claimed his First Amendment rights were infringed by prosecutors seeking to enforce Food and Drug Administration limits on drug promotion.
Working a territory on Long Island, Alfred Caronia sold Xyrem, a drug approved for narcolepsy, for Orphan Medical Inc., now known as Jazz Pharmaceuticals, which has its main office in Philadelphia and a facility in Langhorne.
A jury found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commerce. Doctors can prescribe any drug approved by the FDA, but drug companies cannot promote a drug for an illness not approved by the FDA and on the official label. Such promotion is considered "off-label."

Caronia argued that violated his right to free speech.

Though drug companies would like to have Caronia's victory extended nationwide, lawyers following the case said that would not happen, at least for now, because the decision was limited to New York, Connecticut, and Vermont, the area covered by the U.S. Court of Appeals for the Second Circuit.

Former federal prosecutor Virginia Gibson, a partner at Hogan Lovells in Philadelphia, said in December that the Second Circuit decision "does not change the safety regime that the FDA runs to protect patients."

"It may prompt the FDA to issue more guidance on a number of topics," she said.

In a statement, the agency said, "FDA does not believe that the Caronia decision will significantly affect the agency's enforcement of the drug-misbranding provisions of the Food, Drug and Cosmetic Act. The decision does not strike down any provision of the . . . act or its implementing regulations, nor does it find a conflict between the act's misbranding provisions and the First Amendment or call into question the validity of the act's drug approval framework."

Contact David Sell at 215-854-4506, or follow on Twitter @phillypharma. Read his blog at

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