The FDA plans to do two new studies supposedly to gauge the “ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion” (see the Federal Register Notice here).
A closer examination of the proposal, however, suggests that the real goal is to promote the Agency's BadAd program and open it up to consumers.
The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program's goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.
There have been several cases where the FDA sent out warning letters based on notices it received from the BadAd program (read, for example, “OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!”).
According to a STATnews article, “Awareness [of the BadAd program] is low, however, according to a study published in 2015 in the Journal of Health Care Communications, which surveyed doctors, nurses and physician assistants who provide ambulatory care.
“The notice for the newest studies suggested the agency may consider creating such a program to prompt consumers to also report deceptive ads.”
I was quoted in the article, saying “It’s possible the Bad Ad program doesn’t go far enough and the FDA is looking to crowd source in order to use the power of consumers to help monitor industry advertising...It smells like they’re trying to gather data to decide whether to create another program.”
Here's why I think that is the goal of the FDA... More