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FDA Plans to Review Policy Allowing Direct-to-Consumer Drug Ads for TV

By Chris Adams
The Wall Street Journal, March 28, 2001

So-called direct-to-consumer advertising has expanded rapidly since 1997, when the Food and Drug Administration issued draft guidance about the types of television spots drug companies could run. Spending on TV ads for prescription drugs has more than quadrupled, to $1.13 billion in 1999 from $220 million in 1996, says IMS Health and Competitive Media Reporting, which didn't have more-recent figures available. At the same time, the number of complaints from patients and doctors about the ads has also increased, with doctors saying they are bombarded with requests from patients wanting the latest -- and usually most expensive -- drugs.

Now the FDA is starting a long-planned review of the policy that unleashed the explosive growth in ads. It says it will examine whether drug ads "confuse consumers and adversely impact the relationship between patients and their health-care providers." Among other things, the agency is proposing to commission two surveys -- one of patients, the other of doctors -- to help it decide whether the 1997 guidance, which was finalized in 1999, should be changed, rescinded or kept in place. The agency hopes to complete its review by year's end.

Critics of the advertising, including many physicians and insurers, aren't expecting the FDA to reverse course and begin blocking the ads. But the agency review -- along with debate in Congress over soaring drug costs -- gives critics a platform to demand that the advertising be reined in.

Nancy Ostrove, an official with the FDA's Division of Drug Marketing, Advertising and Communications, says the agency is especially interested to learn if "inappropriate prescribing" is going on, leading to "people getting drugs they shouldn't be getting."

Traditionally, pharmaceutical companies directed their marketing muscle at doctors, who have the authority to write prescriptions. But print ads aimed at consumers became more common in the late 1980s. Then, in 1997, the FDA's guidance opened the door to the flood. When the FDA finalized that guidance in 1999, it said it would conduct the type of review it has just begun, exploring the role of direct-to-consumer ads in all media as well as those specifically made for television.

Many doctors and insurance companies contend that flashy, well-produced ads are sending patients in search of the latest medications even when they don't need them. And harried doctors often prescribe the pills rather than battle -- and possibly lose -- their patients.

"For the doctor, it's a minute and a half to write out the prescription and let the patient go home happy, or 30 minutes of sitting there and explaining why they won't," says Nancy Chockley, president of the National Institute for Health Care Management Research and Educational Foundation. The Washington-based group is funded in part by managed-care companies and government agencies.

With so many patients covered by managed-care plans, there is often little incentive to avoid high-price medicines. "I can't tell you how many times I've said to a patient, 'I'm sorry, I'm going to prescribe a very expensive drug,' and they just say, 'That's all right, doctor, I only pay $10,' " says Thomas Reardon, a Portland, Ore., physician and the immediate past president of the American Medical Association, a physicians' group.

Most of the critics of TV drug ads have mixed feelings on the issue. They believe it is too late to effectively ban them altogether, particularly because patients have come to accept them. But, at a minimum, they want them to give more information about drug safety.

"We're very concerned that 30-second ads simply don't have enough time to disclose the amount of information necessary for patients to understand these drugs," says John Golenski, executive director of RxHealthValue, a coalition of consumer, labor, business and other groups. Among the coalition's members, Mr. Golenski says, some think TV drug ads should disappear altogether, while others believe they provide important consumer information. But, he adds, there is an "absolute consensus" that drug-safety information needs to be more prominent.

The Pharmaceutical Research and Manufacturers of America, the main trade group for drug makers, says any FDA review this year will merely underscore what the group has said all along -- that TV drug ads "empower patients."

"It's important to note that doctors are still in the driver's seat," says Alan F. Holmer, the group's president. He says that people who complain about TV ads because they boost prescription spending are practicing a form of "don't tell, don't ask."

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