The FDA will use computer technology as part of a new study to
measure the amount of time people spend reading the brief summary
in print drug ads.
The study, the first of three the agency is planning to examine the
brief summary, will consider side effects, contraindications and
effectiveness information in DTC print ads for prescription drugs,
according to a description in the Dec. 15 Federal Register.
The FDA said earlier this year it also plans to conduct focus
groups in 2006 to discuss DTC advertising and other topics. Crystal
Rice, a spokeswoman in the FDA’s Center for Drug Evaluation and
Research (CDER), said via e-mail that the three new studies “are
not contingent on CDER’s focus group plans.”
This study “will investigate how and why people use the brief
summary and what parts they find important,” she said. “The other
two studies will investigate the (brief summary) format and
Because the study depends on Office of Management and Budget
approval, Rice could not provide a timeline for the research.
The study’s 420 participants will be recruited at malls and
screened to be either currently diagnosed with high cholesterol,
obesity, asthma or allergies, or caring for someone who has been
diagnosed with one of the conditions.
Subjects will see test ads on a computer. The speed at which they
click the option to move to the next page of a test ad and two
other ads will be measured. In addition, the tests will gauge
comparative speeds between the main page and brief summary page and
between the test ad and the other ads, the FDA said.
The series of studies represents an effort to test some new
approaches for presenting risk information to consumers, something
the FDA suggests is overdue.
“In recent years, FDA has become concerned about the adequacy of
the brief summary,” notes the description in the Federal Register.
Drug firms can use their discretion in fulfilling the brief summary
requirement of the Food, Drug, and Cosmetic Act and often simply
repeat in small type the risk-related sections of the approved
In 2004 FDA released a guidance document offering alternative
methods of disclosing risk information. The guidance encouraged
drug makers to make brief summaries more consumer friendly by
omitting all but the most serious and the most common risks.
But few drug makers have experimented with more readable formats.
One is Pfizer, whose recently launched, consumer-friendly ad for
Lipitor offers important facts like side effects and directions in