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.

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*

Grant support

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.