The U.S. Food and Drug Administration (FDA) is considering new requirements
for how prescription medications are advertised on television. The concern
is that the long litany of side effects listed at the end of advertisements
may overwhelm, or potentially mislead consumers, leading to confusion
about the most serious risks.
The FDA’s study will specifically consider whether side effect warnings
should be limited to the most serious risks. Less serious side effects
would be mentioned as simply “potential additional risks.”
“Our hypothesis is that, relative to inclusion of the full major
statement, providing limited risk information along with the disclosure
about additional risks will promote improved consumer perception and understanding
of serious and actionable drug risks,” the
The FDA has also raised concerns that pharmaceutical companies may also
omit important drug safety information. Researchers at the University
of Wisconsin and Dartmouth University have found that “potentially
misleading claims are prevalent throughout consumer-targeted prescription
and nonprescription drug advertising on television.” In fact, 57
percent of ads were found to be misleading.
To determine what requirements should be used going forward, the FDA plans
to survey 1,500 study participants after exposing them to advertisements
containing various levels of disclosures, and then measure their risk
As San Diego product liability attorneys, we will be closely tracking the
FDA’s study and will provide updates as they become available.
If you or someone you love has been seriously injured by a dangerous or
defective drug, don’t hesitate to
contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.