Off-Label Sales in Jeopardy: Rx Industry Fights for Clarity
• By Michael McCaughan
Off-label use of prescription drugs is worth billions of dollars to manufacturers, but no one likes to talk about it. Defensiveness is understandable, with scores of companies under investigations for allegedly promoting those uses illegally. The truth is that no one is very happy about the current state of off-label medication use, but calls for change are contradictory and tough to resolve.
Michael McCaughan
Who should determine when off-label use of a
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.