Two out of three federal judges on the U.S. Court of Appeals for the Second Circuit determined earlier this month that advertising a drug for uses not approved by the federal government is a free-speech issue.
They’re wrong. It’s not: It’s a consumer protection issue. The question is not whether a sales rep is exercising his or her First Amendment right when touting a drug; it’s whether that rep is acting as, in the words of one critic of the decision, a snake oil salesman.
The U.S. Food and Drug Administration’s regulatory system exists for a reason: to make sure that pharmaceutical drugs are safe for consumers. Obtaining approval for a new prescription medication can be difficult and can take years and heavy investment by pharmaceutical firms. The approval process tests the drug for specific uses, and the drug is thus labeled for those uses.
The firms’ interest in giving that drug as wide exposure as possible is understandable given the cost and expense of developing the drug. But it has been illegal, and rightfully so, for drug companies to promote their products for uses not approved by the FDA, advertising known as off-label marketing.
Doctors are free to prescribe approved drugs for other uses, and there’s good reason for that, as well as limits. As Eric Cohen, a professor at the Medical College of Wisconsin, noted in an op-ed earlier this month, “neither doctor nor patient wants to use a medication that does not work, or that has unacceptable side effects. Such off-label use is often possible, however, because the medication in question has been used for a similar indication, and because of previous experience, in this country or overseas.”
Representatives of drug companies have different agendas and lack the necessary medical experience and knowledge.
In the case in question, as the Journal Sentinel’s John Fauber reported, Alfred Caronia, a sales representative with Orphan Medical, was 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, which involves weak or paralyzed muscles.
The FDA had put what is called a black box warning on the drug stating its safety and effectiveness had not been established in people under 16. The active ingredient in Xyrem is GHB, also known as the “date rape” drug, a powerful medication that acts on the central nervous system.
In a taped conversation Caronia had with a doctor who was cooperating with the government, he said the drug could be used for other muscle conditions such as fibromyalgia, restless leg syndrome and Parkinson’s. He also said it could be used in patients under 16.
Caronia’s claim that it could be used in patients under 16 flies in the face of the FDA warning. How this could be primarily a matter of free speech is puzzling to say the least.
In her dissent from the majority opinion, Judge Debra Ann Livingston argued that by throwing out Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” And she pointed out that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
Exactly. Why would a company go through that expense and time if it’s not necessary? And yet that process is the one of the few safeguards standing between consumers and potentially devastating effects of drugs not approved for a specific use.
Right now, the court’s decision only applies within the Second Circuit, which covers Connecticut, Vermont and New York, but there’s little doubt that this case eventually will get to the Supreme Court. That court should not confuse the real issue at the heart of this case: making sure consumers are protected from drugs not fully tested for all advertised uses. And in the meantime, the FDA should continue to prosecute cases in which such advertising has occurred.