Last week, the Arizona House unanimously passed HB 2382, which safeguards the free speech rights of those in the medical field to share truthful research and information about FDA-approved medicines. Now the Arizona Senate has an opportunity to expand the number of treatment options in doctors’ toolkits, enhance patients’ medical autonomy, and increase access to healthcare. Arizona is poised to be the first state in the country to empower patients and protect this fundamental speech right more broadly than the federal government.
Today, about one in five prescriptions are “off-label,” meaning the medicine is FDA-approved, but it is prescribed for a different use or dosage. Surprisingly, while doctors can legally prescribe off-label, federal law prohibits pharmaceutical companies from sharing information about off-label uses with doctors. As a result, doctors and patients may be unaware of alternative treatment options lawfully available them; and, even if they are aware, the information can be outdated or inaccurate.
The off-label use of cancer drugs is even more common. A recent study found that, among the 10 most-often prescribed cancer drugs in 2010, about 30 percent of those treatments were prescribed off-label. Yet companies face criminal penalties and too often are criminally prosecuted for simply communicating to doctors valuable information about lawful off-label uses for treatments.
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. But a new bill working its way through the Arizona legislature with broad bipartisan support promises to change all of that.
Although immeasurable in its impact on doctors and patients, HB 2382 is a relatively modest reform. The bill isn’t a license to be reckless. It only protects truthful promotion, meaning information that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles.” And HB 2382 only applies to communication between pharmaceutical manufacturers and licensed professionals. In other words, the bill does not permit pharmaceutical manufacturers to advertise off-label uses directly to the public.
With HB 2382, Arizona can lead the way in protecting free speech in medicine. When doctors are fully informed about the lawful treatment options available to them, they can best serve their patients’ individual needs.