ANA Regulatory Rumblings

Kessler Misdiagnoses the Role of Direct-to-Consumer Prescription Drug Ads

Dr. David Kessler, former Commissioner of the Food and Drug Administration (FDA), has seriously misdiagnosed the role of DTC prescription drug advertising.

In an editorial in the January/February edition of Annals of Family Medicine, Dr. Kessler attacks prescription drug ads and erroneously compares them to ads for soap or other consumer products that present minimal risks to consumers. Marketers all agree that prescription drug products are not soap. Unfortunately, Dr. Kessler’s false analogy completely ignores the tremendous differences in the way prescription drugs and soap are sold. His editorial also misstates the role that prescription drug advertising plays in educating consumers.

Unlike soap, you or I cannot simply walk into the store to pick up a drug product. They can be purchased only after talking with a doctor and obtaining a prescription. The FDA must approve all drug products before they go on the market. The agency has very specific rules on how drug products can be advertised to consumers; rules which go far beyond those for the marketing of any other product in our society. Also, the pharmaceutical industry has adopted detailed self-regulatory marketing guidelines that substantially supplement the rules of the FDA.

Walking the Tightrope

This morning I gave the following presenation at the ANA's Advertising Law and Business Affairs Conference.

As we begin the new year, the marketing community faces a dramatically altered political environment. After twelve years in the minority, Democrats have seized control of both houses of Congress. Democrats have regained the power to conduct oversight hearings, control debate and set the agenda for the new Congress. At the same time, the 2008 presidential election season already has begun, increasing the stakes for all political participants. These changes present the marketing community with a set of significant new challenges.

First, some longstanding industry critics are now in charge of key committees. For example, Senator Tom Harkin (D-IA), a strong critic of food marketing to children, is the Chairman of the Senate Agriculture Committee and Chairman of a key Appropriations subcommittee. Senator Ted Kennedy (D-MA), a critic of DTC prescription drug advertising, is the Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee. Congressman Pete Stark (D-CA), another DTC critic, is the Chair of the Health Subcommittee of the House Ways and Means Committee, which has jurisdiction over tax policy.

Speaker Nancy Pelosi (D-CA) has outlined an ambitious plan for legislation in the first 100 hours of the new Congress. Marketing issues could be thrown into that mix. The new Senate Majority Leader, Senator Harry Reid (D-NV), has promised that the new Congress will be a “do something” Congress that will work longer hours to deliver real results for American citizens. Many of our industry critics have been emboldened and believe that the new Democratic Congress will be more receptive to calls for new taxes or restrictions on a broad range of marketing categories.

Many policymakers unfortunately have a very negative view of the role of advertising in our society. TV ads are always the most costly part of a political campaign and members of Congress always remember the negative ads their opponents ran against them. Most do not see much distinction between political ads and commercial advertising.

In the past, many of the serious attacks on advertising came from fringe groups that were out of the political mainstream and had limited respect on the Hill. Now, we face serious attacks from major mainstream groups, such as the Institute of Medicine (IOM); the American Academy of Pediatrics (AAP); the American Psychological Association (APA). These groups may not know much about our industry, but their attacks on advertising have much more resonance with members of Congress.