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

Michael S Sinha; Aaron S Kesselheim

doi:10.1371/journal.pmed.1002564

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

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

Authors

Michael S Sinha¹, Aaron S Kesselheim¹

Affiliation

¹ 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.

Abstract

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.

Publication types

Editorial
Research Support, Non-U.S. Gov't

MeSH terms

Federal Government*
Government Regulation*
Humans
Off-Label Use / legislation & jurisprudence*
State Government*
United States
United States Food and Drug Administration / legislation & jurisprudence*

Grants and funding

This research was supported by the Laura and John Arnold Foundation. ASK is also funded by the Engelberg Foundation and the Harvard Program in Therapeutic Science.