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04-12-2012 | Article

Landmark ruling reverses off-label marketing conviction


Official ruling

medwireNews: A federal appeals court has ruled in favor of a former pharmaceutical sales representative who was accused of promoting off-label use of the drug, sodium oxybate.

The result could mean a regulatory shift in how the government and pharmaceutical industries address a drug's capacity to treat symptoms and patients in a manner not authorized by the Food and Drug Administration (FDA).

Alfred Caronia, a former representative of Orphan Medical - now owned by Jazz Pharmaceutical - argued that his conviction was in violation of his right to free speech, since it was based on a verbal exchange he had with a doctor about off-label use of an FDA-approved drug.

"Regulating speech must be a last - not first - resort," the majority wrote in the ruling. "The government hasn't established a 'reasonable fit' among… drug safety and public health, the lawfulness of off-label use, and its construction of the FDCA [Federal Food, Drug, and Cosmetic Act] to prohibit off-label promotion."

Two of the three judges who made up the panel of the Court of Appeals for the Second Circuit in Manhattan concluded that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting lawful, off-label use of an FDA-approved drug."

FDA approval cannot limit or interfere with medical practice by preventing physicians from making prescription decisions they deem beneficial for patients. Because the agency does not regulate how physicians prescribe approved drugs, it allows approved and unapproved use by doctors.

The lone dissenting judge in the ruling considered the evidence as "ample" enough to conclude "beyond a reasonable doubt that Caronia conspired to introduce or deliver for introduction into interstate commerce, a misbranded drug." Altogether, the decision "calls into question a fundamental regime of federal regulation that has existed for more than a century."

According to the official blog of Hyman, Phelps & McNamara, PC, a large food and drug law firm that provides service to clients regulated primarily by the FDA, the ruling is "very significant… [and] will have wide implications for [the] FDA and the companies and individuals regulated by the FDA."

The implications of the ruling touch on a history of government convictions against pharmaceutical companies for misbranding based on off-label promotion. In 2009, Pfizer paid $ 2.3 billion in a case that involved illegal marketing of its painkiller, valdecoxib. Last July, a record breaking $ 3 billion settlement involved GlaxoSmithKline's illegal marketing of several drugs.

By Peter Sergo, medwireNews Reporter