Arizona will allow off-label marketing under the newly passed Free Speech in Medicine Act (HB 2382). The Act allows manufacturers and their representatives to engage in truthful off-label promotion of drugs, biologics, and devices, but does not require any insurers, payors, or health plans to cover products for off-label uses. This is the first state legislation of its kind.
State government restrictions. The Act prohibits state officials, employees, and agents from prosecuting manufacturers and their representatives for truthful off-label marketing. The state medical, pharmacy, and osteopathic examiners boards, as well as the state Department of Health Services, are likewise prohibited from revoking, failing to renew, or taking other action against the license of manufacturers, their representatives, health care institutions, or physicians solely based on truthful off-label promotion. Further, the Act prohibits the state and political subdivisions from using resources, both personnel and financial, to assist or cooperate with the federal government’s attempt to prosecute manufacturers and representatives under 21 U.S.C. §331 or §352 for truthful off-label promotion.
Lobbying and the FDA. The Goldwater Institute has pushed for such legislation, believing that prohibiting off-label promotion is a violation of the First Amendment and harms patients by limiting the information available to physicians. The Goldwater Institute, which drafted the model legislation upon which the Act is based, will continue to campaign for health care policies that allow providers more freedom to provide care. In the meantime, states will undoubtedly be looking to the FDA to address off-label promotion. The agency has not yet taken official action, although it held a public meeting in November 2016 to discuss the topic.
Companies: The Goldwater Institute
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