Patients with Chronic Conditions Are OK With Off-Label Drug Promotion If FDA Allows It, Will Pharma Do It?
The FDA recently held a Part 15 hearing on regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”
In the notice for this meeting, FDA posed several questions for which it is seeking input at the hearing and afterward. Among these were two questions regarding off-label promotion targeted to patient and consumer audiences.
Results from three different surveys were presented at the hearing on November 9, 2016. Each survey addressed off-label direct-to-consumer (DTC) promotion of drugs by the pharmaceutical industry.
This article summarizes the results of these surveys.
Topics (partial list):
- What Do Industry Insiders Think?
- Does FDA Need Help?
- A Mute Point If Payers Not On Board
- inVibe Survey of Patients
- Consumer Reports Survey
- Will Pharma Do It?
- Submit Your Comments
Download the full article (PDF file) here:
- PharmaGuy’s Curated Off-Label Articles on Scoop.It
- FDA Guidance on Responding to Unsolicited Requests for Off-Label Information
- Off-Label DTC Advertising: Will FDA Be Forced to Allow It
- Off-Label Uses Promoted in DTC Ads for Diabetes Drugs
- Duke Chimes in on Off-Label Drug Promotion
- Ethical Off-Label Drug Promotion: What Would It Look Like?
@zdunnhealth in Favor of Direct-to-Consumer Off-Label “Communications” to Consumers as Long as Not “Promotional”
Issue: Vol. 15, No. 5: December 2016
- Direct-to-Consumer (DTC) Advertising & Marketing
- Patient Education
- Physician Marketing & Promotion
- Regulatory Compliance