Drug ads include a lot of warnings — probably too many, FDA says

CHICAGO — A woman is getting her hair done at the salon, but she’s mortified of what her stylist will think of the red patches on her neck.

She decides to have a “serious talk” with her dermatologist, who prescribes Humira, the best-selling drug in the world, made by AbbVie of suburban Chicago. And her skin clears up.

But then for the next 35 seconds, the announcer rattles off a list of side effects. Humira can lower a person’s ability to fight infections, including tuberculosis. “Serious, sometimes fatal events” — including infections, lymphoma and other types of cancer — have happened. There’s something about heart failure, blood, liver and nervous system problems.

It’s a long list of warnings — maybe too long, the Food and Drug Administration says.

The FDA is studying whether those warnings, in broadcast and print ads, overwhelm and confuse consumers. The agency says no one reads more than half of the fine print in drug ads, and of those who do, 55 percent say it’s hard to understand.

The upshot: People are increasingly ignoring risk factors, the agency says, and thus missing some important safety information.

In recent months, the FDA has been talking with drugmakers, medical groups and consumer groups about ways to make the ads clearer and drive home the most important safety risks.

A few weeks ago, the FDA rolled out “reissued revised draft guidance.” Under the proposed guidelines, drugmakers would still be required to include “black-box warnings” about the most serious risks. But they wouldn’t have to rattle off a laundry list of every possible side effect.

“In general, FDA believes that exhaustive lists that include even minor risks distract from, and make it difficult for, consumers to comprehend and retain information about the important risks.”

Meanwhile, some consumer advocates are worried about the FDA’s proposal, saying drug advertisers could get too much leeway on which risks to omit.

“Just like the old song, the drug companies will get to accentuate the positive and eliminate the negative,” said Dr. Sidney Wolfe, director of Health Research Group at Public Citizen, a consumer and health advocacy group in Washington. “It all bodes very poorly for consumers.”

Drugmakers already have wide latitude about how to advertise their products. The FDA cannot limit the amount of money they spend on advertising, nor can it ban ads for drugs that have serious risks. Drugmakers don’t have to spell out how the drug works, mention the cost of the drug, or if there is a similar drug with fewer risks that can treat the condition.

Under the Federal Food, Drug and Cosmetic Act, ads must mention at least one approved use for the drug and the generic name of the drug as well as side effect information “in a manner similar to that used for the benefit.”

Drugmakers don’t have to submit advertising to the FDA for approval in advance, but if the agency believes an ad violates the law, it can send a letter to the company telling it to immediately stop the ads.

FDA spokeswoman Sarah Peddicord said the updated guidance is “meant only to provide recommendations to industry.”

The FDA is accepting comments on the proposed guidelines for print ads until Oct. 5 and is continuing to study broadcast advertising.

The drug companies say current guidelines have forced them to spend too much space in print ads and time during TV commercials outlining all possible side effects, and not enough time explaining the benefits or saying how the drug works. The result is that up to half of the ad is a list of everything that can go wrong, with the announcer sometimes reading it at breakneck speed.

Broadcast commercials, too, could be boiled down. The FDA has been doing research on TV and radio drug ads for insomnia, depression, high cholesterol and other diseases, using patient focus groups. The agency says it is still studying how to update guidelines for broadcast, which have been in place since 1999.

The proposed guidelines come as drug companies are spending billions of dollars a year to push the latest treatments for everything from shortness of breath to depression. Last year, drugmakers spent $4.5 billion on direct-to-consumer advertising, up 30 percent from 2012, according to Kantar Media, a market research firm that specializes in media consumption.

John Kamp, executive director of Coalition for Healthcare Communication in New York City, a group representing ad agencies that specialize in drugs and medical devices, says, “The ads need to be more direct. Shorter is better.”

The drug industry’s trade association, Pharmaceutical Research and Manufacturers of America, said it largely supports the FDA’s move to make printed advertisements more “patient-friendly.” It said the shift from reams of fine print to a summary was “a positive step toward providing important risk information to consumers.”

AbbVie declined to comment on the ad with the woman visiting her hair stylist.

Eli Lilly, based in Indianapolis, spent $249 million last year to advertise Cialis, an erectile dysfunction drug, making it the country’s most advertised drug. The company said it supports the FDA’s goal of “improving risk communication” to patients.

Cialis ads often include a laundry list of warnings: headaches, upset stomach, backache, sudden loss of hearing, swelling of throat and tongue, and of course, the need to see your doctor if you have an erection lasting more than four hours, one of the most memorable drug warnings ever.

“Lilly believes patient labeling should be clear to consumers, summative rather than exhaustive,” the company wrote to the FDA in April.