FDA Issues New Drug Ad Guidelines

(AP)  The government wants ads for prescription drugs to begin bearing lists of side effects that are easier to read and understand.

The Food and Drug Administration advised manufacturers Wednesday to stop using those lines of warnings in tiny print - usually written in doctors' jargon - that often appear at the bottom or next page of most drug ads in newspapers and magazines.

Patients do not read the lengthy warnings, the FDA said, and when they try, the guidance is not understood.

"This may be a case where less is more in terms of consumer understanding," said the FDA's commissioner, Mark McClellan.

Federal regulations require that the $2.8 billion worth of direct-to-consumer drug advertising be truthful and present fair information about a drug's risks as well as its benefits.

That is why television ads generally have a narrator listing side effects at the end. For print ads, companies usually fulfill that obligation by putting a drug's professional label on the back of the ad; this page is full of tiny print written for doctors, not consumers.

The FDA's new guidelines make clear that drug manufacturers should find a more consumer-friendly way to present the risk information. At the very least, companies should:

Use laymen's terms, not medical jargon in their ads. For example, a drug maker should not say a drug is "contraindicated" for certain patients, but say instead, "do not use."

Use bigger type. Some of today's ad warnings require a magnifying glass to read.

Put the most common risks and the most potentially lifesaving information first.

Instead of making readers turn the page to find the warnings, the guidelines suggest that drug makers present the warnings in the ad.

McClellan noted that companies probably will save advertising dollars because manufacturers will make drug ads smaller.

But the change drew fire from critics. It comes just a week after Rep. Henry Waxman, D-Calif., disclosed that FDA warnings ordering misleading ads to be pulled have dropped by 75 percent since the late 1990s.

"The new guidance misses the crux of the problem, which is FDA's abysmal failure to take strong action against the false and misleading claims in current (direct-to-consumer) ads," Waxman said.

"The example the FDA gives opens the door to abuse: FDA says that it's OK for drug companies to replace a consumer warning that says a drug may cause 'acute liver failure' with a warning that the drug 'can affect your liver function,"' he added. "That's consumer-misleading, not consumer-friendly."

McClellan said the guidelines are important because they make it more clear what "what is and isn't out of bounds," so his agency can focus on egregious violations instead of manufacturers that just did not understand the rules.

But even some drug makers had a lukewarm reaction.

Pfizer Inc., a leader in consumer-directed ads, already has moved away from technical jargon in the warnings on some of its ads. But Pfizer Vice President Robert Clark would not say if the company would make the other switches - which the FDA has recommended but not ordered - until it completed its own evaluation of whether they would improve consumer understanding.

The guidelines go into effect immediately.


By Lauran Neergaard