ARTICLE | Politics, Policy & Law

Freeing speech

Amarin, Pacira cases will determine how FDA changes off-label regulations

October 26, 2015 7:00 AM UTC

FDA and the Department of Justice will try this week to contain the damage from two pending lawsuits that threaten to undermine the legal doctrine FDA has applied for decades to prevent off-label promotion, and to limit drug company communications about investigational drugs.

The outcomes could determine the pace and scope of change in FDA's regulation of communications between manufacturers, physicians, payers and patients. While the velocity is uncertain, the pressure for change, which has been building for decades, seems irresistible. ...