Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run
Executive Summary
Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.
You may also be interested in...
Disease Awareness Campaigns Still Must Tread Carefully, Observer Says
Sponsored plotline for General Hospital was careful to avoid irking US FDA; agency withdrew its guidance on disease awareness campaigns in 2015, but its influence appears to be continuing, according to a former official.
Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy
Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.
Has FDA Lost Its Grip? The Amarin Deal
While the FDA was insistent its settlement with Amarin Corp. plc, which a federal district judge has signed off on, only applies to that company, in which the agency has agreed to not stand in the way of the firm sharing "truthful and non-misleading" information about certain unapproved uses of its fish-oil pill Vascepa (icosapent ethyl), the deal, nonetheless, shows US regulators can be flexible, or at least, when they're backed into a corner.