Healthy Skepticism Library item: 16775

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

Seetharaman D
US drugmakers urge FDA safety logo for Internet
Reuters 2009 Nov 9
http://www.reuters.com/article/rbssHealthcareNews/idUSN0927327020091109

Abstract:

• PhRMA recommends logo ahead of FDA meeting

• FDA looks at how social media promotes drugs, devices

• Agency looking at whether more regulation needed

• Google, Pfizer among those sending representatives

Full text:

A drug industry group on Monday urged the U.S. Food and Drug Administration to adopt a universal safety symbol for Internet content containing FDA-approved information about a medicine or medical device.

The proposal from the Pharmaceutical Research and Manufacturers of America, which represents some of the biggest drug makers in the world, came ahead of an FDA public meeting this week on how FDA-regulated prescription drugs and medical devices are promoted in social media and on the Internet.

PhRMA said the logo would be coupled with a link leading Web users to FDA-regulated information about the device or drug. Whether that link would go to the FDA’s or drug maker’s site or another forum is up for debate.

“We’re intentionally not filling in all the blanks,” said Jeffrey Francer, PhRMA’s assistant general counsel, in an interview. “We’re introducing a concept.”

Francer, who will be speaking at the meeting, said during a media briefing on Monday that the FDA should set the conditions on the use of the logo by drug makers.

The FDA’s two-day meeting, starting Thursday, will include speakers from Eli Lilly, Pfizer, Sanofi-Aventis, Google, consumer groups and marketing companies.

“The reason the FDA is having these hearings is because of widespread concern about the promotion and marketing of prescription drugs,” said Steven Findlay, senior health policy analyst at Consumers Union, the nonprofit publisher of Consumer Reports magazine.

Findlay plans to advocate at the meeting for the placement of a link to the FDA’s online content on Web sites highlighting a specific drug or device when the site is owned or supported by makers of that product.

During the hearing, the FDA will explore how the agency’s regulation of advertising and promotional labels should be applied to the Internet and social media, and whether added regulation is needed.

Topics that will be discussed include what online messages drug makers are responsible for, how companies can achieve balance in ads within the confines of a 140-character Twitter message and when Internet linking is appropriate or misleading.