Monday, November 16, 2015

The First Amendment and Off-Label Drug Marketing

Should a pharmaceutical company be allowed to actively promote and market a drug for off-label (unapproved by the FDA) use? Consider, for example, a drug that lowers triglycerides, called Vascepta. The FDA has approved it only for patients with extremely high triglyceride levels, because in these patients the drug has been proven to lower the risk of heart disease. However, the drug is not approved for patients with "only" very high or high triglycerides, because there is no proof that it actually lowers the risk of heart disease in these patients.

Understandably, the drug company wants to sell the drug to as many patients as possible, and there are at least 10 times more patients with lesser elevations of triglycerides than there are patients with extremely high triglycerides. So the company sued the FDA, saying that under the First Amendment (freedom of speech), they have the right to promote the drug to patients as a triglyceride-lowering drug, even though there's no evidence that it would benefit them in terms of reducing the risk of heart disease. The FDA disagreed, arguing that under a 1962 law, drugs are only approved when they have been proven both safe and effective at reducing the risk of a medical relevant condition.

In August a federal District Court judge ruled that the drug company could promote the drug as a triglyceride-lowering agent because it's a true statement, and therefore is protected by the First Amendment. Requiring additional evidence of clinical effectiveness, according to the judge, would be suppression of free speech. The ruling in effect ties the FDA's hands in terms of requiring that drugs actually do something important before they can be marketed.

If the court ruling stands, we may be entering an era where drugs are promoted directly to the public because they do something measurable (in this case, lower triglycerides), without evidence that they are clinically effective (in this case, reduce the risk of heart disease). Rest assured that in their marketing campaigns, the drug companies will do everything in their power to imply that their drugs do something useful, without actually saying it. Even though we might agree that protection of free speech is important, is this truly in the public's best interest?

It's not clear whether the FDA will appeal the ruling to the Supreme Court, but this one is worth watching.

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