In a strange decision, the United States 2nd Circuit Court of Appeals, which has jurisdiction over Connecticut, New York, and Vermont, ruled that a drug sales representative who promotes “off-label” uses of a particular drug is exercising their “freedom of speech.” The Court decided in a 2-1 vote, in United States v. Caronia (pdf), that the criminal conviction of Alfred Caronia, a former sales representative for a pharmaceutical company, be vacated. The case was an appeal of the sales representative’s conviction for promoting an off-label use of the drug Xyrem, which is approved for treatment of narcolepsy. The Court stated that “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”
The Court also found that the FDA allows off-label use by physicians, but “prohibits the free flow of information that would inform that outcome,” while “the government’s prohibition of off-label promotion by pharmaceutical manufacturers provides only ineffective or remote support for the government’s purpose.” The Court also ruled that it construes “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” It also stated “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
By law, pharmaceutical companies are only allowed to market drugs according to what is stated in their package labeling which is approved by the FDA. Off-label uses are the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. Physicians are legally allowed to prescribe drugs off-label (as long as it is not contraindicated), but the pharmaceutical company cannot directly or indirectly influence off-label use. In most cases, off-label use isn’t dangerous, nor is it particularly unethical. In case it’s not clear, the FDA considers a sales representative an advertising or promotional tool, so the FDA has always prevented sales reps from promoting off-label uses of regulated drugs.
Earlier this year, GlaxoSmithKline (GSK) was fined $3 billion by the United States Department of Justice for improper marketing of their medications. In particular, GSK was fined for promoting off-label uses for several drugs including Wellbutrin, Paxil, Advair, and Lamictal. In 2009, a Stryker sales representative in Ohio pled guilty to felony “misbranding of a medical device.” The FDA has a long history of policing (literally) how pharmaceutical and medical device companies market their products.
This ruling can only be applied in the 2nd Circuit, which includes the states of New York, Connecticut, and Vermont, and does not prohibit the FDA from taking action against off-label promotions in the other 47 states. For it to have wider applicability, the ruling would need to be appealed to the US Supreme Court, which in the past has supported the odd belief that corporations are people and have the same constitutional protections as the individual in rulings such as Citizens United v United States, held that the First Amendment prohibited the government from restricting independent political expenditures by corporations and unions.
Already, the pharmaceutical and medical device trade publications are licking their lips over what this may mean for marketing products to physicians. Inside Medical Devices, a trade journal for the medical device industry, has already weighed in with what can only be described as barely concealed glee:
Although this case involved pharmaceutical promotion, this decision raises significant questions about the government’s ability to prohibit truthful, non-misleading off-label promotional speech, including with respect to devices. Caronia represents a significant affirmation of First Amendment principles for speech related to marketing of medical products. For the first time, a federal court has placed First Amendment limitations on the government’s ability to criminally prosecute off-label promotion of legally marketed medical products. The case therefore has potentially far-reaching implications for government regulation in this area.
According to the New York Times, the trade group for the pharmaceutical industry, Pharmaceutical Research and Manufacturers of America (PhRMA), said it was pleased with the ruling:
PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.
But before the medical device and pharmaceutical corporate marketing staff drop their golf clubs and start celebrating, let’s look at this effects of this ruling a bit more rationally.
But really, what are the practical effects? Physicians do prescribe drugs for off-label indications. This does not mean that they randomly try drugs as experiments on their patients, they usually are aware of peer-reviewed studies that show one drug may be useful for other uses. A typical example would be a drug not approved for pediatric use. But that might include a 17 year old, which for some physicians is no different than an adult. In US v. Caronia, the rep was caught on audiotape promoting Xyrem to doctors as a treatment for insomnia, fibromyalgia and other conditions, for which there was evidence of effectiveness, but were also uses not approved by the FDA at that time. Physicians were already using the drug for other indications, and the sales rep was just making sure that doctors knew about it, an act that is still against FDA regulations. Except in states covered by the 2nd Circuit Court of Appeals.
There may be other unintended consequences of off-label promotion. It may put pharmaceutical companies at greater risk of product liability lawsuits, because they no longer have the protection (whether it is actual or not) of stating “FDA approved use.”
Finally, there is even a more practical issue. Sales reps just don’t see physicians as often as the large pharmaceutical companies think they do. An editorial from a physician in his blog, White Coat Underground, makes some key points about the usefulness of sales reps:
First of all, doctors shouldn’t be getting their information from drug reps. It’s hard enough parsing through the literature, with its publication biases, decline effect, and drug company shenanigans—hard, but not impossible. What’s not so hard is finding appropriate non-corporate-sponsored Continuing Medical Education (CME) credits. Conferences, websites, medical associations all give docs access to information, information less biased than that from the people who stand to benefit from your prescribing habits.
Drug reps are, by reputation, young, attractive, and sociable. They also tend to want to feed you. Many medical centers, especially the ones that participate in medical education, have banned drug reps. But doctors offices often let them in. (Full disclosure: we let them in, but don’t let them bring lunches. Certain drugs, like ALL asthma drugs, aren’t available as generics, and we need the samples.)
I guess sales reps are good for food and product samples. That’s it. No real physician is going to get their information from a sales rep. I personally consider sales reps to be an anachronism from the pre-internet days, especially for brand name pharmaceuticals, and disposable medical products.
In some very specific fields of medicine, sales reps are very knowledgeable and useful. Back in the early days of interventional cardiology (the field of cardiology where catheters are placed inside of coronary arteries to diagnose and treat blockage), I was in product development marketing (a group that tested new cardiology products with key cardiologists). One time we had launched a new device, and a physician was having difficulty using it in a patient. The local sales rep and I, got into surgical scrubs and lead aprons, and taught the cardiologist on how to use the device properly. Without our training the cardiologist would not have been able to complete the complex procedure, nor, to be honest, would we have sold the product. Our sales reps were highly trained (and so was I), and we weren’t there to entertain the physician. But this type of sales rep is rather rare these days.
The sales rep in this First Amendment case was not doing anything truly unethical. He was not promoting the drug for a use that was not dangerous or even unsafe. He was actually promoting it for a legal use, just one that he wasn’t allowed by the FDA. I want to remind the reader that off-label use of drugs is not illegal.
Two of the three justices in US v. Caronia ruled that the FDA did not have the legal authority to restrict free speech in promoting an evidence-based and legal use of the drug. It is also important to note that the one dissenting justice stated that this decision might establish a legal precedent that could eventually lead to blocking the power of the FDA to regulate drug sales. If the FDA is hamstrung in regulating pharmaceuticals, I imagine it will erode whatever limited power the FDA has in regulating non-evidence based supplements and other junk medicine out there.
Freedom of speech should not give corporations the right to say whatever they want about their products. The FDA, despite the beliefs of certain groups like vaccine denialists, is a strong, but imperfect, defender of US citizen’s health when using regulated pharmaceuticals and devices. Without the FDA and strong regulations, pharmaceutical companies, and their marketing organs, the sales rep, will be tempted to make patently false claims, reducing the trust in what pharmaceuticals and, by implication, what physicians can do for patients. What scares me more is that without regulation, we will have a pharmaceutical anarchy, and medications and devices that have legitimate and life-saving uses will be overwhelmed by the commercial spam promoting products that lack a even a small degree of evidence of effectiveness for a particular indication.
The medical and economic cost of this decision is unhealthy. And worse yet, the legal and ethical pharmaceutical industry will morph into something that looks just like today’s supplement pushers. And ten years from now, I will be sitting at my desk complaining how Big Pharma lacks evidence-based products. I don’t want a world of junk medicine.
The 2nd Circuit ruling is plainly illogical, because the FDA needs to the power to protect its citizens from the misguided adventures of pharmaceutical sales reps. With so much pressure on these reps to get bigger paychecks or even keeping their jobs, stretching the bounds of drug labeling, as I mentioned above, is part of the drug sales rep culture. Of course, by the time this ruling is appealed and heard by the Supreme Court, it’s very possible that President Obama will have appointed new justices who don’t think much of corporation’s First Amendment rights. Let’s hope.
Steven Novella at the NeuroLogica blog summed up this case perfectly:
Freedom of speech does not give people carte blanche to make whatever commercial speech they desire. Looked at another way – I am a big believer in the free market, but markets are constructs and they are constructed of rules and regulations. In the marketplace of medicine, unrestricted claims and marketing, in my opinion, lead to chaos. The consumer will be overwhelmed by complex claims that are very difficult to assess because they involve understanding the scientific literature in a thorough and nuanced way. There needs to be at least a basic filter in place to weed out patently false claims and give a minimal reassurance that health claims are reasonable – and then let the public decide among legitimate claims. In an unregulated marketplace, however, legitimate claims will be overwhelmed by slick but false or misleading claims. I give as evidence for this the supplement industry.