Today, some of the most popular branded drugs are nearing patent expirations, thus opening the doors to generic competition. In order to compete with generic companies, many big-name drug makers, such as Bayer Healthcare Pharmaceuticals, now rely heavily on direct-to-consumer advertising. An example is commercial advertisements for their product, Yaz.
In 2006, the FDA approved Yaz as a birth control pill that has a side benefit of treating mood-related psychological problems called premenstrual dysphoric disorder.
In 2007, the agency approved another side benefit of Yaz; that of improving moderate acne. However, Yaz contains drospirenone, a progestin that can cause excess potassium production in some patients, and its side effects include an increased risk of serious heart and other health problems.
Aimed primarily at women in their 20s, Yaz has been known for its slogan — “Beyond Birth Control” — which promotes it not only as pregnancy prevention, but as a lifestyle drug. This is where Bayer's problems started.
The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company’s ads ran afoul of federal laws against promoting the unapproved uses of a drug.
As part of an unusual crackdown on deceptive consumer drug advertising, the FDA and the attorneys general of 27 states have required Bayer to run new ads to correct previous Yaz marketing.
In addition, Bayer has agreed, for the next six years, to submit all Yaz ads for federal screening before they appear. Wait a minute…hold up; something sounds "bass ackwards" here.
The Food, Drugs and Cosmetics Act of 1938 gave the FDA greater authority to regulate the food and drug industry. Under this act, the FDA was granted the power to regulate the therapeutic claims drug manufacturers printed on their product labels.
Perhaps the most striking feature of the 1938 law was that the act introduced mandatory pre-market approval for new drugs; (I feel the problem beginning to emerge…wait for it….wait for it…) but authority over drug advertising, however, rested with the Federal Trade Commission (FTC). (And here is our problem!)
The FDA regulates the initiation of clinical trials, they accept safety and efficacy results of the trial, they approve a drug for marketing, and they even regulate safety of drugs post-marketing; but the FTC is the authority over drug advertisements?
If pre-market approval of new drugs by the FDA is required, then why aren't commercials also pre-approved by the FDA before airing? Isn't a commercial the same as a drug's package insert? And what does the FTC know about clinical trials, i.e., safety and efficacy anyway?
So, is Bayer unethical because they have been involved in deceptive advertising? Yes and no.
Yes, because while these commercials empower women to make their own decisions, it is also Bayer's responsibility to provide all of the information to consumers just as they would to the FDA. In the case of direct to consumer drug commercials, there is a fine line between creative marketing and responsible marketing. While Bayer may try to use different techniques to market their product, each commercial must be treated like a verbal package insert.
However, I also say "No" because Yaz is available by prescription only. While a commercial may suggest to a woman to speak with her physician concerning Yaz, it is also the physician's responsibility to know the benefits and risks and to prescribe drugs accordingly; not because a consumer viewed a commercial.
Either way, it appears that the Yaz controversy may raise new questions about whether the FDA oversight is sufficient. If deemed insufficient, then direct to consumer advertisement may become a thing of the past. With a staff of 52 people, the FDA division that oversees drug promotion cannot keep up with the tens of thousands of marketing and advertising items produced annually by drug manufacturers.
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In theory, the drug manufacturers have to include the main warnings from the package insert, but I have learned there are no concrete rules about just which adverse events must be included in advertising. Sometimes, not all adverse events mentioned in the package insert are included in commercial advertising. Since advertising is a form of labeling, it is hard to argue against your contention that ads should be submitted to the FDA in advance.
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