Yet medical professionals in the United States today operate under what amounts to a gag order that prevents doctors and patients from having the best, truthful information about their medical care. Under federal law, pharmaceutical companies can be charged with a crime simply for telling doctors about legal, safe, alternative uses for an approved medicine. In other words, government routinely censors the communication of valuable information that could help improve, and even save, people’s lives.
Off-label Treatments
About one in five prescriptions in the United States is used “off-label.” “Off-label” means that the medicine has been approved for use by the U.S. Food and Drug Administration, but the physician is prescribing it for a different use, or at a different dosage, than the FDA approved. Off-label prescriptions are entirely lawful; Medicare even covers them. And they are commonplace: among the 10 most frequently used cancer treatments in 2010, 30% were off-label. An overwhelming majority (87%) of oncologists report that off-label treatments are important to their practices.
Amoxicillin, approved as an antibiotic for adults, is often prescribed off-label to treat ear infections in children. Citalopram, a drug approved for treating depression, is sometimes prescribed off-label to treat symptoms such as stuttering, irritable bowel syndrome, and hot flashes in menopausal women. Magnesium sulfate, which is approved to prevent seizures for women in pre-eclampsia and to control seizures in eclampsia, is commonly used off-label to stop women from undergoing pre-term labor. Even aspirin has off-label uses; it is FDA-approved for pain, fever reduction, and cardiovascular disease, but it is sometimes used off-label to prevent coronary disease in diabetics.
Yet while doctors can legally prescribe off-label, federal law generally prohibits pharmaceutical companies from sharing information about off-label uses with doctors. As a result, doctors and patients are often unaware of alternative treatment options that are lawfully available to them and, even if they are aware, the information they receive may be outdated.
The reason the FDA gives for barring speech about off-label uses is that it protects against “misbranding,” which means misrepresenting what a drug or treatment can do. The FDA uses this concern to require pre-approval of a medication’s advertisements, package label, brochures, and patient education materials.
In the FDA’s eyes, it isn’t just those who share false or misleading information about a drug who are subject to punishment for misbranding. Even if a drug is legal and prescribing it for off-label use is legal, it is “misbranding” for the drug maker to share accurate information about the off-label use. Thus the agency punishes drug companies and their employees if they promote or advertise truthful information about the legal use of a drug that the government has approved for sale.
The consequence is that doctors and patients may never learn of effective alternate uses for legally approved medications. In the words of Samuel Nussbaum, a senior fellow at the University of Southern California’s Schaeffer Center on Health Economics and Policy, “Even if a health care decision maker asks all of the right questions, they may still not be able to access the necessary information they need because manufacturers are hesitant to provide some information due to uncertainties in the laws and regulations that govern what they can and cannot share.”
The Right to Share Information
The right to speak and share information freely is protected by the U.S. Constitution and all state constitutions. Nothing in either the First Amendment or the state protections makes any distinction between different kinds of speech. Yet the U.S. Supreme Court has held that the Constitution does not provide the same protections for commercial speech—speech that advertises a product or service—that it provides for other types of speech. That means that government may sometimes censor even lawful, non-misleading advertisements.
That is the basis on which the FDA has prosecuted drug makers for honestly informing medical professionals about possible uses for their medicines. Fortunately, the courts have begun to take a skeptical view of this. In a 2013 case, United States v. Caronia, the Second Circuit Court of Appeals overturned the criminal conviction of a pharmaceutical sales representative who was punished for promoting off-label use of the drug Xyrem. The court held that the communication of information about a legal activity is fully protected by the First Amendment and that “the government cannot prosecute pharmaceutical manufacturers and their representatives … for speech promoting the lawful, off-label use of an FDA-approved drug.”
Yet despite the apparent breadth of that decision, the FDA announced that the ruling would not significantly affect its enforcement practices. Instead, it resorted to a legal technicality: rather than prosecuting off-label advertising outright, it would use off-label speech as evidence of misbranding, a maneuver that supposedly would not violate the First Amendment. But this is too clever by half: what is “branding” if not speech?
This legal tactic is representative of the FDA’s effort to avoid a showdown over the free speech rights of pharmaceutical companies in this area. As far back as 2000, the D.C. Circuit Court of Appeals struck down guidelines the FDA had issued that regulated what information drug companies could provide for use in textbooks and limited the ability of companies to sponsor continuing medical education programs. After the court opinion was issued, the FDA declared that its regulations did not actually prohibit off-label promotion in textbooks or education programs in the first place. That rendered the case moot, ensuring that the Supreme Court would never hear the case.
Then in 2015 a federal judge in New York issued a preliminary injunction against the FDA, permitting Amarin Pharmaceutical to share information about the off-label use of its fish-oil drug Vascepa. Vascepa was FDA-approved to treat adults with severe triglyceride levels, and Amarin was in the process of seeking approval for use in adults with slightly lower triglyceride levels. While that approval was pending, Amarin wanted to share its research regarding that larger population but feared the FDA would prosecute it for doing so. The firm asked the judge to bar the agency from punishing it. Amarin’s victory established that First Amendment protections extend to all truthful and non-misleading promotional speech, even when the FDA claimed it was only using the speech as evidence of conduct.
The Amarin case seemed on track to establish much-needed precedent to guide the pharmaceutical industry and settle the off-label speech question. But less than a year later, the FDA again managed to prevent an appellate court decision when it entered into a settlement agreement with Amarin that allows the company to market Vascepa as it desired. The FDA also agreed to review up to two proposed off-label communications from Amarin per year under an arbitration process.
That settlement was a deliberate move to avoid establishing legal precedent that would make clear just when and how drug companies can share information. As attorney Coleen Klasmeier observes, “Most legal issues presented by the cases never get ventilated in court or any open legal forum,” and settlements “behind closed doors” undermine “nuanced interpretation” of complex legal matters. In fact, the FDA announced that its settlement “does not signify [any] position on the First Amendment and commercial speech.”
It seems clearer than ever that federal rules making it illegal for pharmaceutical companies to tell doctors the truth about their products—especially when those products and their uses are legal—are unconstitutional.
One reason the FDA may be trying to avoid an ultimate resolution by higher-level courts is that the courts have recently made clear how strong the protections of the First Amendment really are. In 2011, the Supreme Court reaffirmed in Sorrell v. IMS Health that pharmaceutical companies have free speech rights even when they engage in speech for a commercial purpose. That case struck down a Vermont law that prohibited the communication of information relating to doctors’ prescribing practices if the communication was intended to facilitate the sale of medicine. “A great deal of vital expression,” the justices wrote, “results from an economic motive.” Forbidding such communication—or targeting specific types of companies and activities for censorship—was unconstitutional.
More recently, in Reed v. Town of Gilbert (2015), the Supreme Court struck down an Arizona ordinance that imposed different restrictions on speech based on whether the speech related to political, commercial, or religious subjects. Any limit on freedom of expression that is triggered by the content of the message expressed, it said, was a content-based restriction subject to the most stringent constitutional limits. After these decisions, it seems clearer than ever that federal rules making it illegal for pharmaceutical companies to tell doctors the truth about their products—especially when those products are legal and the uses in question are legal—are unconstitutional.
Yet thanks to the FDA’s efforts to prevent a final court decision about off-label promotion, uncertainty remains about the law and risk of punishment that drug and medical device manufacturers face. Only a few months ago, the FDA tried yet again to punish a company for sharing information about its products’ off-label use, this time threatening representatives of Vascular Solutions for telling doctors that one of their company’s medical devices could treat different kinds of varicose veins. According to the company’s chief executive, Howard Root, the FDA treated this communication as “a felony even though our device was FDA-cleared for treating all varicose veins, over two-thirds of our salespeople never sold even one unit of it, sales [of it] constituted only 0.1 percent of our total sales, and not a single patient was harmed.” Root’s company was ultimately vindicated, but the legal battle took five years and cost $25 million—a serious cost for the right to speak the truth.
So long as Congress and the courts continue to allow the FDA to censor speech by medical experts about the legal use of legal medicines, they and their patients will suffer from the lack of clear standards regarding what information can be shared about treatment options. Fortunately, there is another option: one that Arizona has recently put into place to protect patients, medical professionals, and health care freedom.
A New Way
As Congress and the courts fail to rein in the FDA’s assault on free speech, states can step in to protect their citizens’ rights. But how, one might ask, can a state sidestep federal law?
The answer is that states can adopt laws that provide greater protections for a fundamental right than are provided by the federal system. Federal law cannot preempt state law when the federal law or act itself is unconstitutional. When the FDA silences truthful, scientific speech about lawful treatments, it is violating the constitutional right to free speech.
The Constitution provides a basic minimum of legal protection for individual rights, leaving states free to establish greater protections if they wish—a floor, not a ceiling. This was by design: America’s founders envisioned the federalist system providing a “double security … to the rights of the people” by enabling each state to “exercise its police power or its sovereign right to adopt in its own Constitution individual liberties more expansive than those conferred by the Federal Constitution,” as Chief Justice William Rehnquist noted in his 1980 opinion in Pruneyard Shopping Center v. Robins. As Justice William Brennan wrote in his classic 1977 Harvard Law Review article “State Constitutions and the Protection of Individual Rights,” state constitutions “are a font of individual liberties, their protections often extending beyond those required by the Supreme Court’s interpretation of federal law.” States can therefore “respond, through the enactment of positive law” to protect the rights of citizens “without having to rely solely upon the political processes that control a remote central power.”
State constitutions already provide broader protections for free speech, property rights, and the right to privacy than their federal counterpart does. And the Supreme Court has recognized that “regulation of health and safety is ‘primarily, and historically, a matter of local concern.’ ” While federal officials can sometimes override state choices, states have “great latitude … to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.” Thus, states can protect the rights of doctors, patients, and medical professionals to share truthful information about legal medical treatments.
The Grand Canyon State recently took the first step toward using this power to protect the freedom to share information about off-label uses. Last March, Gov. Doug Ducey signed the Free Speech in Medicine Act, a new state law that safeguards the free speech rights of those in the medical field to share truthful research and information about alternative uses for FDA-approved medicines. The act passed the state legislature with unanimous bipartisan support and made Arizona the first state in the country to enact this protection. It will expand the number of treatment options in doctors’ toolkits, enhance patients’ medical autonomy, and increase access to health care.
The act was an obvious and uncontroversial reform. When doctors are fully informed about the lawful treatment options available to them, they can best serve their patients’ individual needs. The law applies only to truthful communications, meaning information that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles.”
Some might argue that the new law does not go far enough, given that it only applies to communication between pharmaceutical manufacturers and licensed professionals, and does not allow pharmaceutical manufacturers to advertise off-label uses directly to the public. Patients will have to rely on doctors to receive, digest, and translate that information for their use. Nevertheless, the act is a major step forward in the effort to rescue patients and medical professionals from the FDA’s gag rule.
As the Supreme Court put it 40 years ago in Virginia Board of Pharmacy v. Virginia Citizens Consumer Council, “Information is not in itself harmful.… People will perceive their own best interests if only they are well enough informed, and … the best means to that end is to open the channels of communication rather than to close them.” This is especially true in cases where the thing being communicated—here, prescribing off-label treatments—is itself lawful. Or, to borrow a line that the Court attributed to a Vermont doctor, “We have a saying in medicine: information is power. And the more you know, or anyone knows, the better decisions can be made.”
