Healthy Skepticism Library item: 12542

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Oversight and Government Reform Committee Chairman Waxman Requests FDA Provide Documents Regarding Drug Company Marketing Loophole
PharmaLive 2008 Jan 22
http://pharmalive.com/news/index.cfm?articleID=507941&categoryid=9&newsletter=1

Full text:

On January 22, Oversight and Government Reform Committee Chairman Henry Waxman wrote to FDA Commissioner von Eschenbach requesting documents related to the FDA’s draft guidance allowing drug companies to use journal articles to promote potentially dangerous off-label uses of drugs and medical devices without prior FDA review and approval.

According to FDA minutes of a meeting, Dan Troy and other drug company representatives urged FDA to issue guidance to protect the companies from “Federal prosecutors pursuing distributors of this information for criminal conduct.”