FDA tees up new brief summary studies
The FDA is asking for comment on two proposed studies to evaluate types of content and format for use in a revised brief summary for DTC print ads.
The agency will investigate the role of context in providing useful risk information to consumers and also will collect information on the usefulness of different formats suggested in an earlier draft guidance on a
revised brief summary.
The content study will create ads targeted to weight loss with two levels of drug side-effect information (short and long) and five levels of context: listing side effects in paragraph form, paragraph with listing of side effects plus their occurrence rate, paragraph plus rate plus placebo effects rate, listing side effects and their occurrence rates in table form, and listing side effects plus their occurrence and placebo side-effects rates in table form.
Respondents will be asked to read the ads and then answer questions about their comprehension and evaluation of the information presented.
The FDA expects to screen 1,800 individuals to reach 900 respondents for the content study and to screen 600 persons to have 300 respondents for the format study. Comments on the proposal will be accepted for 60 days.