In what has been described as a "surprise move" (see below) the FDA recently published a Federal Register notice announcing that it will hold a 2-day public hearing November 9-10, 2016, to obtain input on issues related to off-label communications by manufacturers regarding FDA-regulated drugs and medical devices. FDA says it is "engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/ cleared medical products, and the input from this meeting will inform FDA's policy development in this area."
What's even more surprising is that FDA is asking questions about off-label direct-to-consumer (DTC) and direct-to-patient communications in addition to the typical questions about such promotions directed at physicians.
This article summarizes the First Amendment assault on FDA's ability to regulate off-label communications.
Topics (partial list)
Download the full article (PDF file) here:
- A Brief History of Off-Label Promotion
- Chart: 25 Years of Pharma Criminal and Civil Penalties
- First Amendment Challenges
- Is the Battle Lost?
- A Slippery Slope
- Cancer Off-Label DTC May Be First Case?
- Has It Already Happened?
- Duke Chimes in on Off-Label Drug Promotion