Regulatory Corner

May 17, 2001

Dockets Management Branch
(HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Docket No. 01N-0078

The American Advertising Federation is pleased to submit these comments on the Food and Drug Administration's proposal to survey physicians and patients to examine the impact of direct-to-consumer (DTC) promotion of prescription drugs.

The American Advertising Federation is the unifying voice for advertising. Our membership encompasses all facets of the advertising industry including advertisers, advertising agencies and the media. AAF also represents 50,000 advertising professionals in over 200 local advertising federations across the country and 6,000 students on over 200 college campuses. AAF membership includes companies that make and sell pharmaceuticals, advertising agencies that develop DTC advertising and media that sells time and space for DTC advertising.

Although we believe that it is unnecessary, the AAF does not object to the FDA's proposed survey. We are confident that it will show, as have previous surveys by the FDA and others, that consumers receive numerous benefits from DTC advertising.

There can be no doubt that consumers benefit from advertising. In the historic case, Va. Pharmacy Bd. v. Va. Consumer Council, 425 U.S. 748 (1976), the U.S. Supreme Court recognized the value of commercial speech:

As to the particular consumer's interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day's most urgent political debate.

The court was referring specifically to the economic benefit of price advertising for prescription drugs. Because direct-to-consumer advertising of pharmaceuticals addresses specific health issues, consumers derive an additional benefit from the ads.

According to the FDA's earlier survey, 27 percent of those recalling ads said DTC advertising had at some time caused them to talk to their doctor about a specific medical condition or illness for the first time. Thus, DTC advertising contributed to the earlier diagnosis of previously undetected illnesses. It seems logical to infer that DTC advertising also results in more visits to physicians by consumers, which would result in greater detection of medical conditions.

DTC advertising stimulated more discussions of treatment options. A 2001 Prevention Magazine survey found that 32 percent of consumers who have seen a DTC advertisement have talked with their doctor about an advertised medicine. Slightly more than half of all those consumers say their doctor discussed non-drug therapies with them. According to the FDA survey, 81 percent of respondents indicated they sought more information about advertised pharmaceuticals by talking to their doctor.

Since DTC advertising helps with early detection of medical conditions, it plays a role in lowering healthcare costs and increasing success rates. The earlier a condition is diagnosed, the greater the chances that it can be effectively treated. In addition, early treatment options tend to be less expensive than later, and more invasive, treatments.

Contrary to the concerns of some skeptics of DTC advertising, consumers pay attention to both the risk and benefit information in the pharmaceutical ads. It is no surprise that the earlier FDA study revealed that 87 percent of respondents heard claims about the benefits of the advertised drug. However, 82 percent said they heard information about risks or side effects, and 81 percent information about who should not take the drug. Prevention Magazine found that over 80 percent of consumers thought DTC advertising did an excellent or good job of providing information about both serious and non-serious risks of the products. Thus, consumers are receiving a balanced picture of the products.

In addition, 73 percent said they would read all of the small print risk disclosures in print advertising if they were especially interested in the advertised drug. An additional 12 percent said they would read almost all of the disclosures.

DTC advertising may be particularly effective in reaching the elderly and lower income consumers who have fewer information sources than high-income consumers. According to a 1999 survey by Age Wave IMPACT, 62 percent of consumers between the ages of 50 and 64 said DTC had made them more aware of medication options they had not previously considered. We believe the results would be similar for lower income and minority consumers and urge you to include relevant questions in the survey.

Many critics of DTC advertising are concerned that physicians will be pressured into prescribing pharmaceuticals against their will. However, according to the FDA survey, only 50 percent of patients were given a prescription for the drug that they asked about. It may in fact be surprising that this figure is not higher, given the fact that the patients are visiting their physician because of a condition similar to that described in the advertisement.

The AAF respectfully suggests that in addition to its own survey, the FDA include existing research when looking at consumer and physician attitudes towards DTC advertising. In particular, the survey referred to earlier by Prevention Magazine, Survey on Wellness and Consumer Reaction to DTC Advertising of Rx Drugs. We believe the information in the Survey would be a useful supplement to the FDA's findings.

Respectfully submitted,

Jeff Perlman

Executive VP-Government Affairs & General Counsel