FDA tees up new brief summary studies

Share this article:
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to consumers and also will collect information on the usefulness of different formats suggested in an earlier draft guidance on a 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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Headliner: Ipsen head leads continental charge

Headliner: Ipsen head leads continental charge

"When I look at the business, I actually see patients in my mind. I don't see numbers."

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets