The FDA might be following the lesson learned in the “boy who cried wolf” story. The agency is considering a study on whether those long lists of adverse effects seen on TV drug ads might be overkill, STAT reports.
FDA officials worry that most people simply tune the warnings out. Holly Fernandez Lynch, a bioethicist at Harvard Law School, told STAT: “You don’t even bat an eyelash that this product could kill you, which is kind of an indicator of how ubiquitous it is.”
The FDA says that drug ads must strike a fair balance between the benefits of the drug and the possible side effects. It’s not always clear just where the line should be drawn. All the possible side effects of a drug are contained on the pages attached to every prescription. That information can be shortened for the sake of an ad.
The agency described its proposed plans for a study in a Federal Register notice:
“Prescription drug ads are unique in that they are required to provide both benefit and risk information whereas other ad types tend to include only benefit information,” the FDA said. “The Office of Prescription Drug Promotion (OPDP) plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads through empirical research. The main study will be preceded by up to two pretests designed to delineate the procedures and measures used in the main study.”
The FDA’s proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. Interested parties can provide comments on the proposal until July 17.
Pharmaceutical companies spend about $5 billion a year on ads.