Libertarian groups around the country are pushing state lawmakers to give drugmakers more leeway to promote their medicines with a unique message: Pharma should be protected by free speech laws.
The argument appears to be proving salient: Two states have passed laws permitting drugmakers to advertise what are known as off-label uses of drugs, and lawmakers in at least three other states are expected to take up similar bills next year. The ultimate goal, supporters told me, is to get a bill passed by Congress, a move that could reshape how the Food and Drug Administration oversees the promotion of medicine.
“The problem we see is federal law is prohibiting medical professionals from getting truthful information about lawful treatments,” Christina Sandefur, executive vice president of the Goldwater Institute, a Phoenix-based free-market/libertarian think tank, told me recently.
In seeking to loosen off-label restrictions, the Goldwater Institute and other groups are touching on the area between the FDA's authority over medicine and the practice of medicine, which is largely overseen by state medical boards. They're also trying to argue the federal government is treading on the pharmaceutical industry's right to free speech, something critics also dispute has any standing.
Off-label prescribing, when doctors give their patients medication for a use different than what the FDA approved it for, is legal and common. Some studies estimate nearly a fifth of all prescriptions are off-label. One prominent example is aspirin, which was used for years to reduce heart attacks before being approved for such a use.
Critics of this movement say many off-label uses for drugs have little rigorous scientific study to support their safety and efficacy and drugmakers already have a lot of leeway to talk to doctors about off-label uses of their products. There's also concern that the Goldwater Institute is trying to significantly lower the standard for what's considered a safe use of a drug, opening the door for the return to “snake oil” salesmen.
“Figuring out what’s truthful and not about a drug is the entire point of the FDA’s process,” Nathan Cortez, who teaches FDA law at Southern Methodist University’s Dedman School of Law, told me. “Who else is to say what’s truthful?”
The groups involved in the movement to permit off-label drug promotion are fresh off a win after President Donald Trump May 30 signed into law a bill to permit the terminally ill to sidestep the FDA in getting access to experimental drugs, a policy known as right to try. They're hoping to repeat that success and turn another relatively unknown issue into federal law within a few years.
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