TV ads for prescription drugs often have a nasty side effect: Anyone listening to the obligatory list of unwanted conditions could easily decide the conditions are worse than the disease. The Food and Drug Administration is aiming to fix that with new rules for TV and print ads that target consumers.
The FDA by February is expected to revise rules for the "brief summary" section of so-called direct-to-consumer ads aimed at patients. That's the part of the ad reciting the potentially harmful or unwanted side effects of a drug. Depending on the side effects, the summary can come across as comical when the obligatory list is raced through or as unbelievably scary as a litany of debilitating conditions is rattled off.
Drug companies and at least one consumer group are pressing the FDA to let drug companies simplify the summary. Instead of cramming in a long list of side effects, including many that are remote possibilities, they want the FDA to let advertisers list only the most likely or serious conditions that could result from taking a drug.
"Right now, brief summary for drug ads is not brief nor understandable," said Rebecca Burkholder, director of health policy for the National Consumers League (NCL). "It doesn't do consumers any good." The rushed listings are generally ignored by viewers, she added.
The FDA is expected to require that ads reveal where complete listings of side effects and full uses can be found if they are not included in TV ads, such as company Web sites or literature.
The FDA changes are good news to drug manufacturers.
"Overloading consumers with too much risk information at an early stage in their awareness of a health issue has the potential to frighten rather than inform them," Pfizer Inc. Associate General Counsel George Evans told the FDA last month. Pfizer's Vioxx and Zocor were the No. 1 and No. 5 drugs in terms of ad dollars in 2000, according to the most recent study by the Kaiser Family Foundation. In terms of sales, they ranked No. 15 and No. 4, respectively.
The FDA move toward more-lenient rules is a relief for drug manufacturers, which have been under fire since restrictions on TV drug ads were lifted in 1997. Since then, TV's share of consumer-oriented drug ads has climbed from 29% to 64%. The total market for such ads climbed 130% during that time, from $1.1 billion to $2.5 million.
Critics, including Ralph Nader's Public Citizen, say the barrage of ads purposelessly jacks up the cost of health care because drug companies raise prices to cover the cost of buying time. Also, they say, patients are persuaded to seek expensive brand names rather than cheaper generics or even may seek treatments they don't need.
The drug companies say that such criticism is wrong and TV ads are but one component of a broader effort to educate consumers. "Television is best utilized when the intent is to reach a large audience with a relatively simple set of messages," Merck chief of global regulatory policy David Blois told the FDA.
NCL's Burkholder agrees. The group initially had reservations about ads, she said, but surveys indicate that consumers feel drug ads increase the awareness of health problems and treatments. NCL's main worry, she added, is that the FDA is inadequately staffed and funded to ensure compliance with rules prohibiting misleading statements. "We applaud any change intended to make sure the information is simpler to understand, but we want to make sure the rules are enforced."
Although some lawmakers have threatened legislation to rein in drug ads, the FDA's predilection for lightening the regulatory load has found a government ally in the Federal Trade Commission. Last month, the FTC said evidence debunks notions that advertising directly to consumers has increased the sale of inappropriate drugs or raised drug prices.
FTC went on to call for loosening the rules to make ads "easier for consumers to understand" as long as they contain "truthful, non-misleading information." The FTC also favored price comparisons and other types of relative cost claims. Endorsements and testimonials should be permitted as long as they meet FTC guidelines for over-the-counter drugs and other products.
