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FDA Examines Ways to Improve Consumer Understanding of Prescription Drug Ads
Date:6/20/2011

the second study, additional information about side effects was included on the second page.  The third study tested four different brief summary formats:

Traditional (block text paragraphs), Question and Answer (with headings framed in the form of questions), Highlights (based on the highlights section of the physician labeling), and Prescription Drug Facts Box (resembling the current Over the Counter Drug Facts label).

Key findings of the studies include:

  • Adding a serious risk did not hinder people's understanding of the risk information.
  • Including additional information about how often side effects occur and how long they may last did not hinder people's understanding of the risk information.
  • Participants who viewed the Drug Facts format were better able to recall risks than those who saw the traditional format.

FDA researchers Kathryn Aikin, Ph.D., Amie O'Donoghue, Ph.D., and Helen Sullivan, Ph.D., M.P.H., and Jack Swasy, Ph.D., from American University designed and led the three experimental studies.

A copy of "Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs" will be available in the September/October 2011 issue of "Medical Decision Making."

For more information:

Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs

Background on Prescription Drug Advertising

Division of Drug Marketing, Advertising and Communication (DDMAC) Research  

The FDA, an agency w
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SOURCE U.S. Food and Drug Administration
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