Imagine that you are battling cancer. You – and your doctor – may not be aware of the latest medical advances that could save your life. Federal gag rules prohibit manufacturers from sharing truthful information about their FDA-approved treatments if that information falls outside of the FDA-indicated condition, treatment dose, or population. A manufacturer may face criminal penalties for sharing this information even if that information is truthful and the treatment would offer a better option for the patient.
Aspirin is FDA-approved for a variety of ailments, such as pain, fever, and cardiovascular disease, but it is a commonly used prophylaxis for coronary disease in diabetic and other high-risk patients, a use that is lawful but not the FDA-approved use.
Arizona recently made history by unanimously adopting the Goldwater Institute’s Free Speech in Medicine act, becoming the first state in the nation to protect the right of manufacturers to communicate truthful information about drug uses beyond those listed on their labels.
Yesterday, the Goldwater Institute released Restoring Free Speech in Medicine: How state lawmakers can overcome FDA regulations that keep doctors and payers in the dark to provide policymakers across the nation with a roadmap for helping patients. Naomi Lopez Bauman and Christina Sandefur discuss how the federal gag rule prevents physicians from learning about treatments that could improve or even save their patients’ lives and how the states can legally remedy the situation.
“Restricting the sharing of truthful medical information can have fatal consequences,” said Lopez Bauman, director of healthcare policy at the Goldwater Institute in a statement. “Prescribing FDA-approved drugs for conditions, patient populations, or dosages not listed on their labels—called ‘off-label’ use within the industry—is common and legal: About one in five prescriptions is dispensed in this way. Since using medicines ‘off-label’ is legal, it is imperative that physicians have the most up-to-date research and information on those drugs, but the federal gag order keeps them in the dark. This hinders doctors’ ability to provide the best care possible.”
The inability to share information about FDA-approved devices and treatments also violates the constitutional right to free speech.
Lopez Bauman and Sandefur explain that since states can protect free speech rights more broadly than the U.S. Constitution, states can provide these protections for free speech in medicine.
“States are leading the way in ensuring that manufacturers and physicians can share information about all the tools in a doctor’s arsenal to fight illness,” said Sandefur, executive vice president at the Goldwater Institute. “Protecting communications about lawful treatment options ensures that healthcare providers are better able to serve their patients.”
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