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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