The United States Court of Appeals for the Second Circuit based in New York City threw out the conviction for the sales representative who had promoted off-label use of a drug that was not approved by the Food and Drug Administration. The decision was made by a three-judge panel (2 to 1).
The court said that the government had persecuted the sales representative for promoting the drug off-label. Alfred Caronia from Orphan Medical Inc. was convicted of promoting the drug Xyrem used to treat narcolepsy for off-label uses. The U.S. Food, Drug and Cosmetic Act, or FDCA, says that doctors can prescribe FDA-approved drugs for off-label uses, but the pharmaceutical companies and their representative can't promote the off label uses.
"We construe the FDCA as not criminalizing the simple promotion of a drug's off-label use because such a construction would raise First Amendment concerns," the Court said, reports FDA Law Blog.
Recently, GlaxoSmithKline was forced to pay $3 billion for promoting drugs for off-label uses while Johnson and Johnson agreed to pay $2.2 billion in a Risperdal settlement. Similarly, in 2009, Pfizer Inc. also agreed to pay $2.3 billion to end an investigation into its advertising of drugs.
"Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label. And this decision hits at the heart of the government's theory," said John R. Fleder, a director at the law firm Hyman, Phelps & McNamara who represented the F.D.A. while working at the Justice Department, reports The New York Times.
The Court also ruled "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," reports FDA Law Blog.
The case is U.S. v. Caronia, 09-5006-cr, U.S. Court of Appeals for the Second Circuit (New York) and the 82-page decision can be found here.
Published by Medicaldaily.com