Life Science Compliance Update

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March 27, 2017

Arizona Enacts Law: Pharmaceutical Companies to Legally Communicate Off-Label Treatment to Medical Professionals

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As many of our readers know all too well, pharmaceutical companies are not permitted to discuss off-label, legal, alternative uses for an approved drug with physicians and other healthcare professionals as regulated by the FDA. However, a bill in Arizona, HB 2382 that passed unanimously (The Free Speech in Medicine Act) has changed that in Arizona. On March 21, 2017, Governor Doug Ducey signed the bill into law, lifting the aforementioned off-label promotion restriction and allowing drug companies to communicate with doctors and other healthcare providers about safe and effective alternative uses for approved prescription drugs.

The law, effective in ninety days, safeguards the free speech rights of pharmaceutical industry members to share truthful research and information about FDA-approved medicines.

“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.

The Goldwater Institute has campaigned for “Right to Try” laws and the Free Speech in Medicine Act follows on the heels of the campaign, with thirty-three states adopting “Right to Try” laws.

“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.

Roughly twenty percent of written prescriptions are “off-label,” meaning that the medicine is FDA-approved, but is prescribed for a use or dosage different from the FDA-approval. 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.

The off-label use of cancer drugs is even more common than typical prescriptions. A recent study found that among the ten most prescribed cancer drugs in 2010, approximately thirty percent were prescribed off-label. Even with those facts and statistics, pharmaceutical companies face criminal penalties (and have been prosecuted) for communicating information about lawful off-label uses for approved treatments to doctors and other healthcare professionals. 

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.

Since Arizona enacted this protection for industry, it is likely to expand options in doctors’ toolkits, enhance patient autonomy, and increase access to healthcare. It will be interesting to see if any other states will follow suit and implement similar laws.   We will watch carefully to see if this law, which aligns with several recent legal cases, prompts the FDA to finally adjusts their guidance on off-label communications.

The Goldwater Institute is pursuing other healthcare policies, all in an attempt to remove barriers that prevent healthcare professionals from providing the care they are trained to give.

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