by Naomi Lopez Bauman
May 15, 2018
Government is censoring the communications of valuable information that could help improve — and even save — people’s lives. These speech restrictions not only undermine patient care but also violate the free speech protections in the federal and state constitutions.
About one in five prescriptions in the United States is “off-label,” meaning the medicine has been approved for use by the Food and Drug Administration, but the doctor prescribes it for a different purpose, patient population or dosage than the FDA approved. While doctors can legally prescribe off-label (and the practice is quite common), companies can face criminal prosecution and penalties from the FDA for communicating about off-label uses for a product outside of a narrow and often murky set of federal requirements. The threat of fines or even jail time for speaking the truth has had a chilling effect on pharmaceutical companies’ willingness to share information with doctors and payers – leaving patients in the lurch.
But that is changing, thanks in part to our Free Speech in Medicine Act.
Last year, Arizona became the first state to adopt the Free Speech in Medicine Act. The law, which passed both chambers unanimously, restores the right to freely exchange truthful information about legal treatments and provides healthcare providers and payers with the tools they need to make informed healthcare decisions for patients.
And just last week, similar legislation was signed into law in Tennessee after unanimously passing both of their chambers. This year, several more states are expected to introduce similar bills.
Courts and legal scholars alike have long been critical of the FDA’s gag order on off-label speech, and we are seeing a renewed interest in the legal community. Building upon the Goldwater Institute’s research, the Federalist Society’s Regulatory Transparency Project released a new paper calling upon the FDA to follow the states’ lead and once and for all declare that truthful and non-misleading communications about off-label uses of approved treatments are permissible.
The speed of medical advancement continues to accelerate, while FDA gag rules belong in the dustbin of history. The idea that sharing information – which is readily available in almost every aspect of our lives — is somehow inconsistent with a physician’s ability to evaluate the evidence to make a treatment determination for his own patient is absurd.
Policies that withhold and conceal truthful, scientific information are not only incongruous with modern technology, they keep important treatment decisions hidden from those practitioners who are in the position to effectively use them.
Naomi Lopez Bauman is the director of healthcare policy at the Goldwater Institute.