It’s a shame that in a nation that prizes free speech, the government routinely censors the communication of valuable and truthful information that could help save people’s lives. But it’s a fact. Federal law strictly limits how pharmaceutical companies – those with the most knowledge about drugs and their possible uses and side effects – can share information about the legal use of their products. In this area, as Wayne State University Professor Peter Henning put it, “speaking the truth can violate the law.”
This type of speech is often referred to as “off-label use” because it involves the use of legally approved medicines to treat conditions other than what the Food and Drug Administration approved the medicine to treat. For example, a drug the FDA approved as a pain reliever might also work for “off label” use as a sleep aid or an allergy medicine. These “off label” prescriptions are entirely legal. In fact, about one in five prescriptions are “off-label” today.
Nevertheless, the FDA subjects companies and their representatives who promote or advertise a drug’s off-label use to prosecution for the crime of “misbranding.” In other words, while the drug is legal, and prescribing it for “off label” use is legal, it’s not legal to talk about prescribing the drug for “off label” use. As a result, doctors and patients may never learn of effective alternate uses for legally approved medications. And pharmaceutical companies wanting to promote their products by sharing truthful scientific information about “off-label” uses face harsh criminal penalties.
The First Amendment protects the freedom of speech and makes no distinction between different kinds of speech. But the Supreme Court has held that the Constitution does not protect commercial speech – speech that advertises a product or service – as much as it protects other types of speech. Under the Central Hudson Test, government may even censor lawful, non-misleading commercial speech if the regulation directly serves a substantial government interest and the regulations are not more extensive than necessary. That rule has been heavily criticized by many judges, but it remains the law today.
In 2011, however, the Court confirmed that the First Amendment protected a pharmaceutical company that engaged in speech for a commercial motive. It struck down a Vermont law that prohibited the transmission of information relating to doctors’ prescribing practices for commercial use. Transmitting the information was legal—just not if it was for a commercial purpose. The Court said that targeting specific types of companies and activities for censorship was unconstitutional. Then last year, it struck down an Arizona ordinance that imposed different restrictions on speech based on whether the speech was political, commercial, or religious. Any limit on freedom of expression that’s based on the content of the message expressed, the Court said, was a content-based restriction subject to the most stringent constitutional limits. It seems clearer than ever that federal rules that make it illegal for pharmaceutical companies to tell doctors true information about the legal use of federally-approved medicines violate the First Amendment.
Few courts have directly addressed whether or to what degree the Constitution protects a company’s right to share information about off-label uses. In 2000, the DC Circuit struck down FDA guidelines that regulated the information drug companies could provide for use in textbooks and limited the ability of companies to sponsor continuing medical education programs. But the FDA later declared that the regulations did not actually prohibit off-label promotion under those circumstances, which rendered that case moot. As a result, the Supreme Court never heard the case.
Over a decade later, in United States v. Caronia, the Second Circuit overturned the conviction of a pharmaceutical sales representative who was punished for promoting off-label use of the drug Xyrem. The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives . . . for speech promoting the lawful, off-label use of an FDA-approved drug.” In other words, because the conduct the representative was promoting was lawful, truthful speech about the conduct was protected speech.
Despite the apparent breadth of that decision, the FDA announced the ruling would not significantly affect its enforcement practices. Instead of prosecuting off-label advertising, which would be a direct prosecution of speech, the Agency would simply use off-label speech as evidence of conduct: the crime of misbranding. But what is “branding” if not speech?
The Agency’s narrow interpretation of the Caronia decision was put to the test in Amarin v. FDA. In that case, a New York federal judge issued a preliminary injunction against the FDA, permitting Amarin 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. Amarin’s initial victory established that First Amendment protections extend to all truthful and non-misleading promotional speech, even speech used as evidence to prosecute conduct.
The Amarin case seemed on-track to establish some much-needed precedent to guide the pharmaceutical industry and settle the off-label speech question.
But last week, the FDA once again thwarted efforts to establish clear guidelines by entering 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.
Some see the settlement as a deliberate move by the FDA to avoid establishing legal precedent regarding when and how drug companies can share information. As Coleen Klasmeier of Sidley Austin LLP noted, “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.”
Indeed, the FDA made clear that its settlement “does not signify [any] position on the First Amendment and commercial speech.”
Eventually, Congress or the courts will have to settle the off-label issue once and for all. In the meantime, manufacturers, doctors, and patients will suffer from the lack of clear standards regarding what information can be shared about treatment options. It’s a shame that in the 21st century, the federal government can censor speech by medical experts about the legal use of legal medicines—but that’s the law today.