Earlier this year Arizona became the first state to allow drug and medical device companies to promote the off-label use of their products. Now the group that advocated for that change hopes other states will follow that lead.
If states approve the so-called Free Speech in Medicine Act, companies could do what the Food and Drug Administration prohibits: Promote the use of drugs and medical devices for uses beyond their approval.
The Goldwater Institute, the Phoenix-based conservative think tank that pushed for the legislation in Arizona, on Tuesday released a report intended to provide policymakers across the nation with a road map to take similar action.
The Goldwater Institute says what it calls a “federal gag rule” prevents physicians from learning about treatments that could improve or even save patient lives. About one in five prescriptions is dispensed for off-label uses for conditions, patient populations or dosages not listed on the drug labels, Naomi Lopez Bauman, director of healthcare policy at the Institute, said in an announcement.
“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,” she said.
The Arizona legislature unanimously passed the bill that allows drug and medical device companies “to engage in the truthful promotion” of drugs and devices to medical professionals.
In its report, the Goldwater Institute said such a law, for instance, would allow a drug company to provide information to an insurance company about evidence that a cancer drug is working on specific gene mutations in an FDA-approved treatment for a different type of cancer that might work in a patient who has colorectal cancer.
Under FDA regulations, companies can sell a drug only after the agency evaluates medical studies and determines the drug is safe and works. It prohibits companies from promoting drugs beyond approved use. Advocates say that protects against the drug-industry promoting off-label use that could lead to improper prescriptions, wasteful healthcare spending and even poor outcomes for patients.
The FDA held two days of public hearings last November to receive feedback on just how companies should communicate with doctors about unapproved uses of drugs and medical devices, a step that could lead to new regulations.
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Off-label prescribing is a common practice for physicians, particularly when treating some of their sickest patients for whom other remedies have failed. But one study found the incidence of side effects also rises sharply when drugs are given to patients for other than their intended purposes.