Pharmaceutical Industry Defends Drug Advertising

Healthfacts, Feb, 2002 by Arthur A. Levin

The Center for Medical Consumers has opposed direct-to-consumer advertising of prescription drugs ever since the ads began to appear in the early 1980's. So my curiosity was piqued when I received a personally addressed promotional packet entitled "Speaking to Consumers - Direct to Consumers Advertising Reference Book" from the drug maker Pfizer.

Speaking to Consumers claims that drug ads are "helping patients lead healthier lives" by empowering them to make more informed decisions about their health. Pfizer says that the ads increase consumer awareness of serious medical conditions and available treatments. And what is the evidence for Pfizer's enthusiastic claims? The company relies almost exclusively on surveys sponsored by the drug industry.

Non-drug industry sponsored survey research, such as that done last year by the Kaiser Family Foundation has reached different conclusions. It found that almost three out of four people who had just seen an ad said they learned little or nothing about the specific health condition mentioned. Almost 60% reported they had learned little or nothing about the specific drug being advertised. In addition, "about half or more of the respondents could not correctly identify the potential side effects after just having viewed an ad."

Pfizer reassures us about the integrity of ad content by deferring to the existence of explicit Food and Drug Administration guidelines requiring that ads not contain misleading or false information and provide a "fair balance" of benefits and risks. Unfortunately, the FDA has fewer than 20 staff assigned to review both consumer and professional advertising. Furthermore, companies are not required to clear their ads in advance for accuracy. The ads are considered innocent 'til proven guilty.

When an ad is found to be in violation, the FDA has limited enforcement capability, relying on issuance of Notices of Violation or Warning Letters. Dozens of such warnings have been issued. But, there is a grace period of a few months before an ad is withdrawn, and rarely are corrective ads required.

Two key pieces of legislation favored by the drug companies are up for renewal by Congress this year, which may explain the Pfizer campaign. The company is worried that some in Congress will want to take advantage of re-authorization legislation to rein in drug ads. The ads are thought by many to be a major factor in drug cost inflation, and Congress will soon be wrestling with the affordability of a Medicare drug benefit. Efforts to control its cost must rely on more use of generic equivalents and older, less expensive brand name drugs, an objective which is poorly served by unfettered advertising.

Just in case policy makers do not buy the argument that drugs ads are good for you, Pfizer not so subtlety reminds them that "direct-to- consumer advertising falls under First Amendment provisions of commercial free speech" and "there is no lawful justification for additional regulatory measures at this time."

With Congress poised to act on the pro-industry legislation in the next few months, closed-door meetings between the drug industry and the FDA have already begun. Industry wants reauthorization of the Prescription Drug Users Fee Act because the money generated has halved the time FDA takes to approve a new drug. (User fees are paid to the FDA by industry for new product application reviews.) Advocates worry that shorter review times have contributed to a disturbing number of new drug safety problems.

Until now, the drug industry has resisted FDA proposals that the law be changed to allow user fees to pay for other activities. In a surprising about face, the industry trade group, Pharmaceutical Research and Manufacturers of America, recently announced its willingness to discuss allowing user fees to fund advertising monitoring and post-marketing surveillance.

While adding additional staff to police drug advertising and safety is a good idea, more needs to be done. The FDA should be given new authority to require prior approval of promotional content and to impose significant civil monetary penalties to discourage repeat offenders who violate advertising rules.

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Arthur A. Levin is the director of the Center for Medical Consumers in New York City.