Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or device, but it is fraught with problems.

The Washington Post asks the question “Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, prescribed for migraines and seizures, might also work on alcohol addiction?” Is it his free speech right to say that any drug has uses beyond what’s listed on its label? Historically, the answer to that question has been no.

Doctors have been allowed to prescribe off-label but the drug industry has not been allowed to advertise use of a drug for which it was not approved. To do so could be considered Medicare fraud, deceptive practices, misbranding and a violation of consumer protection laws.

But misbranding has become increasingly common. Consider the case of Risperdal, the Johnson & Johnson (Janssen Pharmaceuticals) antipsychotic drug approved to treat schizophrenia and a bi-polar condition.  But the drug was routinely prescribed to keep quiet dementia patients in nursing homes, mentally challenged youths or disabled individuals. The known side effects include heart complications and stroke and Risperdal posed a substantial risk of death, particularly in the elderly.

That didn’t stop Johnson & Johnson from promoting those uses – and in many cases, Medicare paid.

As a result, the Department of Justice fined J&J $2.2 billion for off-label marketing. It’s not all bad news for J&J. At the end of the day, Risperdal brought more in profits than fines.

Prompted in part by some recent court decisions, the Food and Drug Administration (FDA) plans to set some new guidelines by the end of the year to clarify what sort of data drug companies will be allowed to disclose to physicians.  The drug industry had argued it was their First Amendment right of free speech to tell physicians about the off-label uses of their drugs, as long as it is truthful. However, fatalities resulted when that happened with Risperdal when it was promoted for off-label use.

Suffice it to say the FDA has had no consistent policy prohibiting the off-label speech and promotion concerning drugs and devices.

GlaxoSmithKline also paid about $3 billion for mislabeling its popular antidepressants off-label. Vioxx was promoted as a treatment for rheumatoid arthritis, for which it was not approved. The drug was found to increase the risks of heart attacks and was linked to at least 55,000 deaths before it was recalled. In the end, the profits derived exceeded the fines.

Medicare even pays for some drugs prescribed off-label.

How can the FDA protect Americans if industry reps can urge the use of untested practices? The truth is that without rules and penalties, the FDA cannot protect Americans from off-label use of drugs. In order to be labeled and approved, a drug must undergo clinical trials and premarket approval to prove safety and efficacy. Off-label use has not undergone any such testing, so how is the FDA protecting Americans and fulfilling its role as a watchdog?