Criticism Of Drug Advertising Prompts Review

In 1997 the FDA opened Pandora’s box when it changed its rules to permit widespread advertising of prescription drugs to consumers. Before that, regulations were so strict that most drug companies didn’t see any value in promoting such products to anyone but health professionals.
Last year, the pharmaceutical industry spent over $4 billion on TV and radio commercials, print ads and Web-based promotions to the public. But a chorus of criticism from Congress, physicians and the public has the FDA and the drug industry scrambling to reevaluate this strategy.
We often hear from parents who are dismayed that their young children see ads on television for drugs to relieve erectile dysfunction. Some physicians are also weary of fielding questions about prescription drugs from patients who saw them advertised on TV. This year the American Medical Association considered resolutions urging restrictions or even an outright ban on direct-to-consumer commercials.
The AMA is studying this issue until its next annual meeting. In the meantime, however, we have received letters like the following:
“I am a doctor and have been practicing for 35 years. I am disgusted by the ads on TV advising patients about the advantages and disadvantages of certain drugs. When you hear the side effects, you are almost ready to throw up because they are sometimes worse than the benefits. I think the government should intervene into the commercialism that is shown by the pharmaceutical industry because most of these ads are very misleading.”
The FDA is sensitive to such critiques. For the first time in a decade, the agency is planning a public meeting to kick off its review of direct-to-consumer prescription drug advertising.
With this initiative on the horizon, the Pharmaceutical Research and Manufacturers of America (PhRMA) is proposing some changes of its own. This industry trade group has just issued voluntary guidelines to its member companies.
They include submitting new TV commercials to the FDA for review before broadcast. Major risks associated with an advertised medicine should be stated in clear, understandable language without distraction.
If this recommendation is adopted, perhaps we will see fewer ads in which actors are laughing, dancing or partying while the announcer rushes through a long list of scary side effects.
PhRMA is also encouraging drug firms to target only appropriate audiences. Theoretically, this should reduce the number of erectile dysfunction drug ads airing when many children are watching.
While these steps may begin to curb some of the abuses that have taken place, many consumers question the value of so many drug ads. Except for New Zealand, no other industrialized nation permits advertising of prescription medicines directly to consumers.
If you have views on this topic and want the industry and the FDA to consider them, you can contact Billy Tauzin, President and CEO of PhRMA; 1100 Fifteenth Street, NW; Washington, DC 20005 and Sheila Dearybury Walcoff, FDA Associate Commissioner; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857.