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Date posted: 12/6/2012

December 7, 2012 - For decades, drug companies have been held to standards set by the Food and Drug Administration when promoting their products, allowing that they only market medications for approved purposes.

The practice of promoting drugs for non-approved uses, known as off-label marketing, has resulted in criminal convictions and billions of dollars in fines from the Department of Justice.

Unfortunately, a recent federal court decision could end the rules meant to protect consumers and give free reign allowing Big Pharma companies to promote drugs for whatever uses will result in higher profits.

The case involved the appeal of the 2008 criminal conviction of Alfred Caronia, a sales representative for Orphan Medical found to have promoted the narcolepsy drug Xyrem for uses not approved by the FDA.

Caronia argued that the requirement that he promote drugs for their FDA-approved use violated his right to free speech. The U.S. 2nd District Court of Appeals agreed, and also added that corporations can rely on the same protections.

Although the decision sounds like a reprieve for an unsuspecting sales representative, it could have much farther-reaching implications.

First, doctors may now recommend prescription drugs based on pharmaceutical company views of their effectiveness rather than on the tested standards of the FDA. Also, drug companies will be held to a much lower standard of care in promoting their products.

The lone judge on the panel that disagreed with the court’s decision commented that the longstanding principles of complying with FDA recommendations had been put into place to protect patients from misleading and unproven claims by drug companies.

Due to the far-reaching effects of the case, experts predict it is headed to the Supreme Court for clarification and perhaps a final showdown.

Until then, patients are cautioned to conduct their own research into the approved uses of any medication they are prescribed.