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PLoS Med. 2018 May 8;15(5):e1002564. doi: 10.1371/journal.pmed.1002564. eCollection 2018 May.

The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

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Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.


In a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.

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