FDA Sues Bayer Over Birth-Control Pill Ads

On Monday, Bloomberg reported that Bayer AG is being sued for misleading consumers and doctors about its popular contraceptive, Yaz. While the drug has been approved by the Food and Drug Administration, publicized company emails appear to uncover Bayer’s plot to advertise Yaz as a treatment for PMS, as well as its attempt to hide serious side effects of the drug.

Bayer is not the only pharmaceutical company that engages in such practices in order to expand business: Merck, Pfizer, and GlaxoSmithKline are just a few among the companies that have received warning letters from the FDA about their false advertising practices.

But, these letters are not enough to significantly change drug marketing. Pharmaceutical companies take advantage of the FDA’s lax enforcement of warning letters to broaden the market for a particular drug. The FDA must take more innovative steps to change drug marketing and inform the public of a drug’s dangerous side effects.

The problem with the FDA’s current policy regarding false or misleading advertising campaigns can be seen in these two Yaz commercials:

In the first commercial – the commercial that the FDA forced Bayer to change – one of the women at the party says she is “an emotional wreck a week or so before [her] period.” She thinks that it is PMS until she goes to her doctor, who tells her “that’s not PMS, that’s PMDD.” To the casual listener, the implication here is that PMS and PMDD are similar in scope, while in reality PMDD is typically a much more severe form of PMS (more information here). This, as well as the list of side effects presented (a list that does not include some of the more extreme symptoms, such as depression), gives the impression that Yaz can treat PMDD and PMS. As the FDA warning letter to Bayer regarding a different Yaz commercial states, “the TV ads misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented of whether their symptoms are actually severe enough to constitute PMDD.” This convenient obstruction of the facts by Bayer greatly increases their market for Bayer to not only PMDD-sufferers, but women who have PMS too.

While the second advertisement does clear up many of the issues mentioned by the FDA, the commercial still takes advantage of poor FDA enforcement. The commercial puts an emphasis on the difference between PMDD and PMS and the fact that Yaz has not been approved for PMS treatment. However, the logo of the drug is still “Yaz: Beyond Birth Control,” which really is not true for most women. Bayer, as well as other pharmaceutical companies, is using FDA’s hands-off approach to make more money.

The FDA’s “most common” course of action, in regards to a false ad, is to issue a warning letter to the pharmaceutical company. While the warning letter is posted online at FDA’s website, drug users must already be aware of a problem with the drug to know to look for the letter. This does not make the vital information regarding the offending drug public enough.

Instead, the FDA should run ads providing more accurate information about the drug, or force the company itself to, like it did with Bayer. However, it would be more useful for the FDA either to review all advertisements before they are made public or have some hand in helping the drug company create the marketing material. This solution would ensure that all advertisements met FDA regulations, as well as possibly create jobs within the FDA itself. Most importantly, however, it would save the lives of people who ask their doctors for medicine that could do them more harm than good.

Photo Credit: Wikimedia Commons