The Arizona House of Representatives recently introduced House Bill 2382 (H.B. 2382), also known as the "Free Speech in Medicine Act." H.B. 2382 would permit pharmaceutical manufacturers and their representatives to engage in "truthful promotion of an off-label use of a drug, biological product or device." H.B. 2382 would not, however, require health care insurers, other third-party payors, or other health plan sponsors to provide coverage for the cost of any off-label use of a drug, biological product or device as a treatment.

H.B. 2382 would prohibit employees or agents of the state from enforcing or applying Arizona's current law, which bars the misbranding of a drug or device, against a pharmaceutical manufacturer or its representative for engaging in truthful promotion of an off-label use of a drug, biological product or device. State employees or agents are further prohibited from prosecuting a pharmaceutical manufacturer or its representative for engaging in this activity.

H.B. 2382 would also prohibit the state and all of its subdivisions from using personnel or financial resources "to enforce or cooperate with the federal government's attempt to enforce or apply [21 U.S.C. §331 or §352] against or otherwise prosecute a pharmaceutical manufacturer or its representative solely for engaging in truthful promotion of an off-label use of a drug, biological product or device." These sections of the federal law generally prohibit the introduction of misbranded drugs into interstate commerce.

Further, H.B. 2382 would prohibit the Arizona Board of Pharmacy, the Arizona Medical Board, the Arizona Board of Osteopathic Examiners in Medicine and Surgery, and the Department of Health Services from revoking, failing to renew, or taking any other action against the license of a pharmaceutical manufacturer or its representatives, a health care institution, or a physician solely for engaging in truthful promotion of an off-label use of a drug, biological product or device.

For the purposes of H.B. 2382, the term "off-label use" means "the use of a United States Food and Drug Administration-approved drug, biological product or device in a manner other than the use approved by the United States Food and Drug Administration."

Please click on the following link to view a copy of H.B. 2382: https://goo.gl/zJBfqL.