By Christina Sandefur and Naomi Lopez Bauman
February 5, 2018
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 year when lawmakers passed HB 2382, which 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 passed the Arizona legislature with unanimous, bipartisan support. In 2017, Arizona became 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. This year a number of states have plans to introduce Free Speech in Medicine legislation, with active legislation already in Colorado and Missouri.
These reforms can’t come soon enough. Today, about one-in-five prescriptions are “off-label,” meaning the treatment 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unaware of alternative treatment options lawfully available them; and, even if they are aware, the information may be out-of-date or insurance companies may be unwilling to pay for them, without further information.
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 companies are subject to criminal penalties for communicating to doctors valuable information about lawful off-label uses for approved treatments.
Yet the FDA continues to punish people for sharing truthful information about perfectly lawful treatments that could help patients. For example, Vascular Solutions, a company that develops life-saving medical devices, was forced to undergo a five-year legal battle with the FDA over off-label communications. CEO Howard Root says of what he calls his “unjust prosecution”:
I took the entrepreneurial plunge in 1997 when I started Vascular Solutions. Over the last 20 years, I’ve led the company in developing over 100 new medical devices that are used worldwide to improve the lives of patients suffering from vascular disease. In the process, we’ve created more than 500 well-paying American jobs and never received so much as a warning letter from the Food and Drug Administration (FDA).
But over the past five years, the Department of Justice has tried to convict me of a felony that could have put me in prison for years. My “crime”? The prosecutors thought it was “off-label” for our salespeople to talk with physicians about using just one version of just one of our more than 100 medical devices to treat perforator varicose veins rather than saphenous varicose veins.
They believed this was 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 constituted only 0.1 percent of our total sales and not a single patient was harmed.
Although Vascular Solutions was finally vindicated, the 5-year, $25-million legal battle took a toll. The cost and uncertainty of these never-ending prosecutions will ultimately harm patients as companies won’t be able to share valuable information with their doctors and insurance companies.
Fortunately, states can protect the rights of doctors and pharmaceutical companies to freely share research and information about legal medical treatments. States already provide broader protections for free speech, property rights, and the right to privacy, than their federal counterpart. And the U.S. Supreme Court has recognized that states have “great latitude” to protect people’s healthcare rights.
That’s why it’s refreshing to see that states are 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.”
Christina Sandefur is Executive Vice President at the Goldwater Institute.
Naomi Lopez Bauman is Director of Healthcare Policy at the Goldwater Institute.