March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may affect how companies can communicate about their products within state borders. Arizona will soon become the first state to allow industry to communicate truthful off-label information about its products; Vermont has introduced a resolution calling for legislation “to rein in” direct-to-consumer (DTC) advertising.
Arizona’s “The Free Speech in Medicine Act” (HB 2382), signed into law March 21 and effective in 90 days, establishes that medical product companies and their representatives “may engage in truthful promotion of an off-label use of a drug, biological product or device.” Further, the state may not prosecute companies or their representatives for doing so.
The Arizona bill was based on model language provided by Christina Sandefur, executive vice president of the Goldwater Institute, who said in a March 22 statement that “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.” The Goldwater Institute previously campaigned for “Right to Try” laws to give patients access to experimental treatments; 33 states have adopted these provisions.
“The Goldwater Institute and Arizona clearly have the policy right,” said Coalition for Healthcare Communication Executive Director John Kamp. “Truthful off-label information from drug sponsors helps doctors and patients know what is needed to make appropriate treatment decisions.” However, Kamp pointed out that according to the law of preemption, “these are FDA, not state, policy decisions. I’m optimistic that the new Gottlieb-led FDA will create rules that make such information sharing the law of the land.”
Earlier this year, Vermont passed a joint resolution (JRS 19) asserting that drug companies spend “on average, twice as much on advertising and marketing as they do on research and development,” and stating that “one of the significant factors contributing to the increasing costs of prescription drugs is the growth of direct consumer promotional campaigns sponsored by the nation’s pharmaceutical companies through print, broadcast, and Internet media.”
The resolution also claims that drug companies’ DTC ads have “the potential to lure a lay person into accepting the positive claims and ignoring the less prominently promoted and possibly dangerous side effects” in spite of these ads being regulated by the FDA. With new leadership at the agency, “The time to rein in direct advertising of prescription drugs to consumers clearly has arrived,” the resolution states.
Specifically, the Vermont resolution seeks legislation that would, among other provisions, restrain drug company expenditures on advertising and marketing, and place a moratorium on DTC promotion while the FDA develops “more effective regulations” of that practice.
“The Vermont resolution, like similar proposals by Sen. Al Franken (D-Minn.), is based on faulty reasoning and bad communication policy,” Kamp said. “Consumer and professional promotion of medicines informs doctors and patients of innovative new options available that often cure or mitigate disease. Suppressing information is bad policy and a violation of the First Amendment.”