A New Kind of Free Speech: Drug Reps’ Pitches to Doctors

Can a pharmaceuticals representative tell a doctor that he should recommend Bupropion, an anti-depression drug, to help patients quit smoking? What about suggesting Zoloft to help with certain sex problems? Currently, the answer is no: when the Food and Drug Administration approves a drug, it specifies which uses may appear on the label, and it bars pharmaceuticals companies from promoting “off-label” uses to doctors. (Doctors themselves, however, may prescribe drugs for off-label purposes.) But pharmaceuticals companies and their lobbyists have raised concerns that this ban could violate the First Amendment. And at the recent annual meeting of the Food and Drug Law Institute, in Washington, D.C., Leslie Kux, the assistant commissioner for policy at the F.D.A., suggested that the agency is reconsidering its rules.

You might be wondering what these labelling policies have to do with freedom of speech. Well, if you construe drug reps’ conversations with doctors as speech, then F.D.A. rules that restrict those conversations arouse First Amendment concerns. They limit what kind of “commercial speech”—the Supreme Court’s term for advertising and other messaging undertaken by for-profit companies—is allowed.

For most of the history of the United States, the Supreme Court understood advertising and promotion to fall outside the bounds of the First Amendment: no matter how much a law restricted commercial speech, it couldn’t be challenged. Then, in 1976, the Court struck down a Virginia law that prohibited pharmacists from advertising the prices of the drugs they sold. The Justices reasoned that “the suppression of prescription drug price information,” whatever its upside, came at the expense of vulnerable consumers: “the poor, the sick, and particularly the aged.” In other words, the Virginia law restricted listeners’ access to speech (in the form of price information) that the First Amendment entitled them to.

From these auspicious beginnings, the idea of commercial speech has transformed into a tool for big companies to fight regulation. In 2011, the Supreme Court struck down a Vermont statute that prohibited pharmaceuticals companies from getting access to information about the prescriptions doctors were writing—information that the companies then used for marketing purposes. The Vermont legislature saw the law as a run-of-the-mill privacy protection. But to six Supreme Court Justices the Vermont law amounted to an unconstitutional restriction on speech: by restricting the information that pharmaceuticals sales reps could gather, it limited what they could say while marketing the drugs. The case—IMS Health v. Sorrell—exemplified a newfound willingness among federal judges to view drug promotion as an issue of free speech. Now when large companies lose advertising-related battles in the legislature, they can resurrect the fights as lawsuits.

In 2012, the U.S. Court of Appeals for the Second Circuit considered the case of a pharmaceuticals sales rep, Alfred Caronia, who had been charged with “misbranding” Xyrem, a drug approved to treat some types of narcolepsy. At trial, Caronia had been found guilty of promoting Xyrem’s off-label uses to physicians—for example, recommending the drug to treat other sleep disorders—and had been sentenced to a year of probation and community service. The Second Circuit, relying on the Sorrell decision, determined that punishing Caronia for “promoting the lawful, off-label use of an F.D.A.-approved drug” was a violation of the First Amendment.

At the time of the Caronia decision, Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group that represents big biopharmaceuticals companies, had been mounting First Amendment arguments against restrictions on off-label promotion for at least a decade. In a 2002 filing with the F.D.A., PhRMA argued that F.D.A. rules concerning the dissemination of “truthful, non-misleading speech about lawful products and activities”—like the off-label prescription of drugs—should be “scrutinized” through the “First Amendment lens.” The organization has been “consistently noting” these problems for the past twelve years, according to Stephanie Fischer, a spokeswoman. But the recent Sorrell and Caronia decisions could give their arguments more traction.

On March 3rd of this year, the F.D.A. solicited public input about whether, and to what extent, drug reps should be allowed to inform doctors about scientific research regarding off-label uses of drugs. In a response to the draft guidance, PhRMA urged the F.D.A. to make its regulations “conform with the First Amendment” so as to “ensure that healthcare professionals may benefit from scientifically accurate, data-driven information.” The message was clear: stop limiting the flow of information to physicians.

PhRMA argues that doctors already prescribe drugs for off-label uses and don’t rely only on pharmaceutical labels to decide the best course of medical action. Mit Spears, the general counsel of PhRMA, argues that the right regulatory approach would be one that enables pharmaceutical sales reps to get drug studies, prescriber data, and other medically relevant information into the hands of doctors, to inform decisions about off-label uses.

Other experts take a more skeptical view of off-label promotion. Amy Kapczynski, a professor of intellectual property and public health at Yale Law School, where I am a fellow, would caution the champions of off-label use to remember that there’s a reason these uses aren’t on the label: they haven’t been shown to be safe. Because privately underwritten studies rarely replicate the stringency of the research used in the F.D.A. approval process, off-label uses are simply not as reliable as their “on-label” counterparts. As Kapczynski put it, “Without testing, and rigorous and independent review of the results, we simply have no way of knowing how new populations will respond to repurposed drugs.” She offered the example of Gabitril, a drug approved to help treat epileptics. When Gabitril was promoted off-label to non-epileptics—for things like anxiety—the drug turned out to cause seizures.

Another organization that responded to the F.D.A.’s March 3rd solicitation for public input was the American Medical Association, which came out in favor of letting sales reps incorporate scientific studies about off-label uses into their promotional materials but also emphasized that the information should be “accurate and unbiased.” In the abstract, this seems like a sensible compromise. But it’s not an easy balance to strike. As doctors continue to prescribe drugs for off-label uses, they need information about how those uses stand to affect patients. Yet the parties with the most information—pharmaceuticals sales reps—inherently have financial incentives to promote off-label uses. There’s good reason to be concerned about the distortion that can result from privately financed scientific research; after all, it’s one of the reasons we require F.D.A. approval of drugs in the first place.

Photograph by Michael Hitoshi/Getty.