New Study Suggests Drug Ads Don’t Adhere to FDA Rules

By August 29, 2011 Uncategorized

A new study published in PLoS One suggests that most prescription drug ads would likely fail to comply with FDA rules regarding their content. That is likely why the FDA instituted its “Bad Ad” program in the first place.

The study, which was conducted by researchers viewing 192 drug ads in November 2008, was done by researchers only counting “unique” ads for various different products. In doing their research, 103 duplicate ads as well as 6 so-called “teaser” ads were found to mention a specific drug but didn’t offer any other information about the drug. The final sample consisted of 83 unique ads, all of which can be found in key U.S. biomedical journals.

The research team found that just 18 percent of the ads were in full compliance to FDA guidelines. A full 49 percent of the ads were not in compliance with FDA guidelines, 41 percent were not in compliance with at least one FDA-described bias and 33 percent did not adhere to the guidelines at all because they omitted information. To make matters worse, almost 60 percent of the ads “did not quantify serious risks needed for safe prescribing of the medications, including death.”

Drug makers have been misleading people in their ads for years. The FDA has issued countless letters to drug makers including Bayer, the makers of the controversial birth control pills Yaz and Yasmin. In fact, the FDA forced Bayer to revise its marketing campaign for Yaz and Yasmin to include the drugs’ links to potentially deadly side effects including blood clots, deep vein thrombosis, heart attacks and strokes. Until the FDA intervened, Bayer was both marketing Yaz and Yasmin’s off-label uses (help clearing up acne and PMS symptoms) just as much as the contraceptive properties and downplaying the drugs’ harmful side effects. Because of those ads, many young women took the pills and suffered from life-threatening conditions and even deaths.

While the Bad Ad Program may help to get some of these ads to include the real risks associated with the drugs, they can do little to help patients who have taken the drug and suffered from the side effects. This new study just draws more attention to how much drug companies get away with before the FDA finds out.