Opinion

A group of consumer, senior, patient safety organizations and small insurers, including Community Catalyst and various state public interest research groups, filed their own comments with the FDA o

A group of consumer, senior, patient safety organizations and small insurers, including Community Catalyst and various state public interest research groups, filed their own comments with the FDA on fair balance. Will pharma listen ?

Consumers want to have their own say in fair balance on prescription drug ads. Among their recommendations ; 

• Information should be presented to consumers in everyday words, i.e. fainting instead of syncope.

• Rather than using the reasonable consumer as the standard for making things understandable, the ad should instead have to be understandable to the least informed person of limited literacy likely to view and be influenced by an ad.

• Significant side effects and risks should be quantified.

• There should be a mandated disclosure that the ad hasnt been subject to FDA approval.

• The adverse event hotline should be included in TV and broadcast ads, not just in print ads.

• The organizations support the requirement that risk info be presented simultaneously in audio and video format.

• The requirements should go into effect as soon as possible.

This is exactly what I have been hearing in two years of qual and quant research and I believe that these requests are reasonable. One other requirement that I believe is necessary is that drug websites have a "roll-over" definition pop-up for complicated medical terms so that consumers can understand label language. It seems that most drug companies do not want to hire writers to take complicated medical language and turn it into easy to understand language that consumers can actually understand and the FDA issues a letter recently to a company that "simplified" it's label language. 
PhRMA should be acting as a bridge between consumer groups and pharma marketers to start down the road to earning trust and doing what consumers want and need not doing what is just best for marketers.