The Never-Ending Saga of Off-label Promotion

This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication. As the Update reported in the August 2017 issue, the U.S. Food and Drug Administration's (“FDA’s”) 23rd Commissioner, Dr. Scott Gottlieb recognizes and indeed publicly acknowledges FDA’s long-standing practice of medicine exception noting that “while the FDA may limit what drug companies may say about their products to the uses that appear on the drug’s official label, physicians may prescribe their drugs for any condition they choose.” He further stated during his confirmation hearings “that doctors are appropriately trained to make medical decisions based on the best interest of their patients.” Consequently, prescribing medicines off label is a common practice, but with life science companies prohibited from sharing information about off-label uses, do physicians get the best available information to make sound clinical decisions? To Read the Full Story, Subscribe, Download a Sample Issue, or Sign In       Related StoriesFresenius to the U.S. Government: When It Comes to the FCA, You Snooze You LoseTo Disclose or Not to Disclose… That is the Question: The DOJ’s FCPA Pilot Program – Insights from Year One and BeyondFalse Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up 
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs