Healthy Skepticism Library item: 11842

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA to Study Whether Brief Summaries in Ads Should be Whittled Down
FDA Week 2007 Oct 26
http://insidehealthpolicy.com/

Full text:

The Office of Management and Budget has given FDA the go-ahead to study whether the brief summaries in pharmaceutical print advertisements are brief enough. Industry backs the study, but is trying to get FDA to change a separate direct-to-consumer advertising study, proposed in August, on whether visuals in television ads distract viewers from side effect information.

The debate on brief summaries in ads dates back to February 2004, when FDA drafted guidelines aimed at improving the summaries. The draft guidelines called for companies to list the most serious, common risks and warned that including too much information could discourage patients from reading the brief summary.

Months later, the Federal Trade Commission urged FDA to study how consumers understand drug risks under different scenarios, including those included in FDA’s brief summary guide.

FDA will conduct three studies. OMB approved the first in April 2006. It looks at how people use the current brief summary.

The next two studies are the focus of the current OMB approval. One involves the content of the brief summary, and the other researches its format.

“Because the body of academic literature on consumer processing of the brief summary is limited, this guidance cannot be finalized until further research is conducted to inform our understanding of how best to present medical information to consumers in this arena,” an FDA statement for the study states.

“Although some research has been conducted on the format of the brief summary, FDA is not aware of previous research investigating the content of the brief summary, nor the specific formats of the brief summary proposed here,” the document states.

John Kamp, executive director of the Coalition for Healthcare Communication, praises the brief summary research. He says the complicated safety information ads must include confuses viewers.

However, Kamp is not fond of another drug ad study, which involves TV ads, and his coalition is lobbying FDA to change the study’s focus.

The aim of the study on TV drug ads is to determine whether visuals distract viewers from risk information. Some researchers argue drug companies use visuals to downplay drug risk information. Visuals distract viewers from side-effect information, and positive visuals may lead viewers to feel good about a product irrespective of negative information simultaneously presented, according to FDA.

The advertising coalition is trying to get FDA to concentrate its research on what patients learn from drug ads and how the ads affect conversations patients have with their doctors.

Kamp says opponents of drug ads think patients march into doctors’ offices demanding drugs they’ve seen advertised on television. Kamp does not believe this is true and would like the matter to be researched.