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Arizona Becomes First State to Allow Pharmaceutical Companies to Legally Communicate Off-Label Treatment Uses to Medical Professionals

March 23, 2017

Phoenix—Imagine a pharmaceutical company executive being charged with a crime simply for telling a doctor about a legal, alternative use for an approved drug. It may sound far-fetched, but current law makes it illegal for drug companies to discuss safe, effective alternative uses for approved prescription drugs with medical professionals. This keeps potential treatments out of the hands of doctors and their patients unnecessarily; and keeps drug prices high by limiting the available treatments for a given condition. This changed in Arizona yesterday when Governor Doug Ducey signed a new law that lifts this restriction and allows drug companies to communicate with doctors and other healthcare providers about safe and effective alternative uses for approved prescription drugs.

HB 2382, The Free Speech in Medicine Act, passed the Arizona State House and Senate with unanimous, bipartisan support. The bill was sponsored by Representative Phil Lovas. The bill safeguards the free speech rights of those in the medical field to share truthful research and information about FDA-approved medicines. Arizona is the first state in the country to enact this protection, which will expand the number of treatment options in doctors’ toolkits, enhance patients’ medical autonomy, and increase access to healthcare.

“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,” said Christina Sandefur, the executive vice president of the Goldwater Institute, and author of the model language upon which HB 2382 is based.

About one-in-five prescriptions are “off-label,” meaning the medicine is FDA-approved, but it is prescribed for a different use or dosage. While doctors can already 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 may be dated.

The off-label use of cancer drugs is even more common. A recent study found that among the 10 most-prescribed cancer drugs in 2010 about 30 percent were prescribed off-label. Yet companies face criminal penalties—and have been prosecuted—for communicating to doctors valuable information about lawful off-label uses for approved treatments.

Although immeasurable in its impact on doctors and patients, HB 2382 is a relatively modest reform. It only protects the sharing of information that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles;” and it only applies to communication between pharmaceutical manufacturers and licensed healthcare professionals. The bill does not permit pharmaceutical manufacturers to advertise off-label uses directly to the public.

“With HB 2382, Arizona is leading 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,” said Sandefur.

The Free Speech in Medicine Act follows on the heels of Goldwater Institute’s successful campaign for “Right To Try” laws that have now been adopted in 33 states. The Institute is pursuing several additional healthcare policies to remove barriers that prevent healthcare professionals from providing the care they are trained to give.



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