Warnings About Specific Side Effects Would Be Eliminated, And Replaced By Boilerplate Language

On March 31, 2006 the Coalition for Healthcare Communication — a group of drug advertising agencies and public relations companies — filed a petition with the FDA asking the agency to do away with its requirement that advertisements for prescription drugs must include specific warnings about serious side effects.

In its FDA petition, the Coalition for Healthcare Communication suggests that patients would be better served if these drug advertisements simply carried a boilerplate warning to the effect that all prescription drugs have potential risks and benefits, which should be enough information to prompt patients to discuss the advertised drug’s risks and benefits with their doctor.

The Coalition’s petition includes this statement:

"While some may think it desirable to tell consumers about all side effects and contraindications, no matter how clearly this information is communicated to consumers, a significant number will lack the education or background to comprehend or act on it."

John Kamp, executive director of the Coalition for Healthcare Communication, based in Washington, D.C., attempted to explain this FDA petition in a March 30, 2006 interview with BrandWeek.com:

"The current format of drug ads is ‘over-warn and under-inform,’ said John Kamp….

"He stressed in an interview that his group did want not warnings to be eliminated altogether, rather that patients get the information from sources other than advertising, such as their own doctor.

“ ‘The risk disclosures in ads [should] be focused on what consumers need to know. They [should] be fashioned to be understood by consumers.’…

“ ‘Ads aren’t perfect communication vehicles, ads are awareness- creating vehicles,’ Kamp said. ‘If you try and make them educational you’re going to cram too much into them.’…

"In contrast, CHC literature states that risk information should be made ‘simpler,’ because current advertising is so ‘complicated’ that “many consumers cannot understand or use [it] on a practical basis.”

"The group wants ads to state that ‘all drugs have risks, including this one,’ Kamp said. ‘You need to talk to your doctor so you can inform the prescription decision.’ ”

The Vioxx recall in September 2004 brought the public’s attention back to the on-going debate over direct-to-consumer (DTC) advertisements for prescription drugs.  Merck & Co. had heavily marketed Vioxx directly to patients, including television ads featuring the Olympic skating medalist Dorothy Hamill endorsing the painkiller.

According to a March 31, 2006 article by reporter Andrew Bridges:

"Representatives of the Pharmaceutical Research and Manufacturers of America did not immediately respond to messages left seeking comment. The organization’s own guidelines stress that drugs ads should include ‘a balanced presentation of the benefits and risks associated with the advertised prescription medicine.’ "

The FDA has six-months to respond to the Coalition’s March 31 petition.  In November 2005 the FDA held two days of hearings concerning DTC drug advertising.

(Posted by: Tom Lamb)