Sometimes, drugs are prescribed and for conditions other than they were created for.
That’s legal, but drug-makers aren’t allowed to market alternative use, known as “off-label” sales or “misbranding.” But when they do, the penalty is usually a fine, not prison, and individuals aren’t typically prosecuted.
That may be changing.
DOJ: W. Scott Harkonen, M.D., and the former CEO of InterMune, Inc., was convicted of wire fraud for the creation and dissemination of false and misleading information about the efficacy of InterMune’s drug Actimmune (Interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis (“IPF”), the United States Attorney’s Office for the Northern District of California and the Civil Division of the United States Department of Justice announced.
The jury, in its third day of deliberations, found the defendant guilty of wire fraud related to a press release issued on Aug. 28, 2002. The defendant was acquitted of a misbranding charge brought under the Federal Food, Drug, and Cosmetic Act.
“This conviction of W. Scott Harkonen demonstrates the Department of Justice’s commitment to hold accountable those corporate executives who provide false or fraudulent information about pharmaceutical trials,” said Ann Ravel, Deputy Assistant Attorney General for the Civil Division. “When corporate executives provide false or fraudulent information about pharmaceutical trials, they jeopardize the public health and welfare.”
As The New York Times notes, it’s a verdict “that could strike fear into pharmaceutical industry executive suites.” Marcus Topel, Dr. Harkonen’s lawyer told the Times he would ask for a new trial or would appeal the verdict. He said the jury verdict was “untenable” and “very inconsistent,” in that Dr. Harkonen was convicted on one count and acquitted on a closely related one.
The maximum penalty for wire fraud is 20 years in prison.