All of us have heard commercials for prescriptions drugs of one kind or another and towards the end of the spot, the announcer rattles off a list of possible side effects or dangers, some which may even include death. Despite the flowers and smiles in the videos and print ads, the warnings can be very serious and the Food and Drug Administration (FDA) that approves drugs for consumer use is now questioning whether the warnings may be overdone. In a story reported in the Chicago Tribune (“Drug ads include a lot of warnings – probably too many, FDA says,” by John Russell, Sept. 4, 2015), the FDA is studying whether those warnings “overwhelm and confuse consumers. The agency says no one reads more than half of the fine print in drug ads, and of those who do, 55 percent say it’s hard to understand.”
As a result, Russell reports that the FDA has found that people are instead ignoring the risk factors altogether and missing the important information that is drown out. “A few weeks ago, the FDA rolled out ‘reissued revised draft guidance.’ Under the proposed guidelines, drugmakers would still be required to include ‘black-box warnings’ about the most serious risks. But they wouldn’t have to rattle off a laundry list of every possible side effect,” Russell reports.
Dr. Sidney Wolfe, director of Health Research Group at Public Citizen, a consumer and health advocacy group in Washington, D.C., however, says that “‘It all bodes very poorly for consumers'” because he says it will allow drug companies “‘to accentuate the positive and eliminate the negative.'” The FDA is not authorized to limit the amount of money drugmakers spend on advertising nor ban ads for drugs that have serious risks. Nor do drugmakers have to spell out exactly how a drug works, the cost of the drug or if there is a similar drug with fewer risks that can treat the same condition. Ads by the drug companies are not pre-approved by the FDA, but if it sees something that is misleading or violates the Federal Food, Drug and Cosmetic Act, the FDA can send a letter to the company to pull the ad immediately. In 2015, drug companies are reported to have spent billions of dollars a year on ads and commercials, up 30 percent from 2012, the Tribune reports. The FDA is accepting comments on the proposed guidelines for print ads until Oct. 5 and is continuing to study broadcast advertising. The latter guidelines have been in place since 1999. To learn more about drug advertisements and what a drug company must tell you about its products, click here.