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Arizona First to Pass Law Protecting Off-Label Promotion of Approved Drugs

Posted in FDA, Legislation and Public Policy, Life Sciences, Pharmaceuticals, State Matters

Arizona has become the first state to pass legislation allowing pharmaceutical companies to promote off-label uses for approved prescription drugs to physicians and other healthcare professionals.

In addition to prohibiting enforcement or prosecution against a pharmaceutical manufacturer for truthful off-label promotion of a drug, the “Free Speech in Medicine Act,” which passed the Arizona State House and Senate with unanimous, bipartisan support, prohibits the State Board of Pharmacy, Medical Board, Board of Osteopathic Examiners, and Department of Health Services from taking any action against a licensee for engaging in such truthful promotion. The law further prohibits the state, and all its political subdivisions, from using personnel or financial resources to cooperate with the federal government’s attempt to enforce federal law prohibiting off-label promotion or to assist in federal prosecution of a pharmaceutical company for engaging in truthful off-label promotion.

The bill was promoted by the Goldwater Institute, which has indicated that it will continue to pursue similar campaigns in other states, but there is no indication yet from the U.S. Food and Drug Administration as to whether the agency will respond to state pressure. Following legal setbacks and industry pressure, the FDA has been publicly engaged in an evaluation of its policies regarding off-label promotion of approved products since November 2016, but has yet to propose any alternative approaches to regulation.

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