Product News and Recalls

Court’s drug marketing decision worries doctors

Many medical professionals are concerned about this week’s decision by the federal appeals court making it legal for pharmaceutical company representatives to market drugs for “off label” uses.

An ABC News report quotes Dr. Richard Deyo, a professor of family medicine at Oregon Health and Science University, as saying: “This risks taking us back to an era when people could promote snake oil without restrictions – a situation I would hate to see.”

Physicians can prescribe drugs for any legal purposes in addition to those specifically permitted under their FDA approval. But until this week, drug companies were not allowed to market drugs for those uses. The three-judge panel of the Court of Appeals for the Second Circuit in Manhattan sided with Alfred Caronia, a sales representative with Orphan Medical.

Caronia had been criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy that involves weak or paralyzed muscles. The FDA required a black box warning on the medication to the effect that its safety and effectiveness had not been established in people under the age of 16.

In a taped conversation with a doctor, Caronia said Xyrem could be used in patients under 16, and was effective for treating other muscle conditions such as fibromyalgia, restless leg syndrome, and Parkinson’s.

The court ruled that Caronia was covered under free speech protections. Some observers predict the case will likely go to the U.S. Supreme Court.

New York psychiatrist Dr. Andrew Kolodny is quoted as saying: “A large portion of Americans already are taking drugs with serious risks that outweigh the benefits. This is going to get much worse. It’s a safe bet that health outcomes will decline from medication side effects, while spending on prescription drugs will continue.”

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