A year ago on this blog, I wrote that under federal law, pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment. Sadly, government routinely censors the communication of valuable and truthful information that could help improve – and even save – people’s lives.
This changed in Arizona last week when Governor Doug Ducey signed HB 2382, 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 Free Speech in Medicine Act, sponsored by Representative Phil Lovas, passed the Arizona State House and Senate with unanimous, bipartisan support. Arizona is the first state in the country to enact this protection, which will expand the number of treatment options in doctors’ toolkits, enhance patients’ medical autonomy, and increase access to healthcare.
About one-in-five prescriptions are “off-label,” meaning the medicine is FDA-approved, but it is prescribed for a different use or dosage. While doctors can already legally prescribe off-label, federal law prohibits pharmaceutical companies from sharing information about off-label uses with doctors. As a result, doctors and patients may be unaware of alternative treatment options lawfully available them; and, even if they are aware, the information may be dated.
Curbing the exchange of information about off-label treatments by those with the most knowledge about the drug’s uses, risks, and side effects not only prevents patients from receiving the best possible care; it violates the constitutional right to free speech. Yet the FDA continues to treat medical innovators like outlaws, subjecting companies to criminal penalties for communicating to doctors valuable information about lawful off-label uses for approved treatments.
Fortunately, states have the power to protect the rights of doctors and pharmaceutical companies to freely share research and information about legal medical treatments. State constitutions already provide broader protections for free speech, property rights, and the right to privacy, than their federal counterpart. And the Supreme Court has recognized that “[r]egulation of health and safety is ‘primarily, and historically, a matter of local concern,’” and 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.”
With HB 2382, Arizona is leading the way in protecting free speech in medicine, removing barriers that prevent healthcare professionals from providing the care they are trained to give. As the Supreme Court put it forty years ago, “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 underlying behavior being communicated – here, prescribing off-label treatments – is itself perfectly lawful. Or, expressed another way by 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.”