Do TV DTC Ads Overstate Rx Drug Risks? FDA Poised to Tip Balance in Favor of Benefits
Benes v. Risks Tipping Balance On Valentine’s Day 2014, FDA sent the drug industry a love letter in the form of a Federal Register submission (published later on 18 February 2014; Docket No. FDA-2014-N-0168) proposing a study of disclosure of “additional” risks in direct-to-consumer (DTC) prescription drug television advertisements.

Specifically, FDA intends to look for evidence that the “major statement” of drug risks as currently implemented in DTC TV ads is often too long and “may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.”

Subjects include (partial list):

  • FDA Letters Often Cite Risk Minimization
  • A Little History of Risk Communication
  • Consumers Less Concerned than Docs
  • Risk-First DTC
  • Risk Straight Talk
  • DTC Without the Risk
  • More Risk Information, Better DTC Ads?
  • More Risk Information, Better Sales?
  • Risk After DTC
  • Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products

Download the full text PDF file here:

Issue: Vol. 13, No. 2: February 2014

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