Bayer to spend $20m to correct misleading advertising for oral contraceptive Yaz

Bayer Healthcare Pharmaceuticals has agreed to spend $20m (£14m; €15.6m) to correct misleading direct to consumer advertising of its birth control pill Yaz (drospirenone and ethinylestradiol), the most popular birth control pill in the United States, with sales of about $616m last year.

The corrective advertisements began running last month and will continue through June, the US Food and Drug Administration (FDA) said.

Bayer reached an agreement with the FDA and 27 state attorneys general, led by Bill McCollum, the Florida attorney general. The agreement follows a warning letter sent to Bayer in October by Thomas Abrams, the director of the FDA’s division of drug marketing, advertising, and communications. It adds new requirements to a 2007 agreement about problems related to Bayer’s non-disclosure of safety risks associated with its marketing of Baycol (cerivastatin), which was withdrawn in 2001.

In the letter, Mr Abrams said two 60 second television advertisements for the drug “are misleading because they broaden the drug’s indication, overstate the efficacy of Yaz, and minimise serious risks associated with the use of the drug.

“Thus, the TV ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act . . . These violations are concerning from a public health perspective because they encourage the use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits, and minimise the risks of Yaz.”

Mr Abrams said the advertisements promoted the use of the oral contraceptive for premenstrual syndrome, although it was indicated for treatment only of premenstrual dysphoric disorder, a more serious and less common problem, in women who choose an oral contraceptive as their method of birth control. Its efficacy for premenstrual dysphoric disorder had not been evaluated when used for more than three menstrual cycles.

Similarly, the advertisements said that the drug helped keep the skin clear, although it was indicated for the treatment only of moderate acne vulgaris in women who wished to use an oral contraceptive.

The television advertisements also minimised the risks of the drug with distracting visuals and rapid scene changes, Mr Abrams wrote, stressing that some of the risks were “serious, even life threatening.” The drospirenone component of the pill is a progestin that can increase potassium concentrations.

The prescribing information warns that women who have disease of the kidney, liver, or adrenals should not use this drug. Also, women should have their potassium values measured during their first month of treatment if they take non-steroidal anti-inflammatory drugs, potassium sparing diuretics, potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, heparin, or aldosterone antagonists daily.

The letter asked Bayer to stop disseminating the promotional materials for Yaz that were the same or similar to those in the television advertisements.

Edmund Brown Jr, the attorney general of California, issued a statement saying that in addition to adhering to the 2007 judgment, the company agreed to:

• •Conduct a $20m corrective advertising campaign consisting of television and print advertisements that have been approved by the FDA’s division of drug marketing, advertising, and communications and reviewed by the attorneys general involved in the suit. The television advertisement must be broadcast on national cable and network television. The print advertisement must be published in magazines with national distribution.

• •Submit all new direct to consumer television advertisement campaigns for Yaz to the FDA for pre-review.

• •Stop making claims about the drug that are not FDA approved. Submit an annual report to each participating attorney general’s office.

A Bayer spokeswoman told the New York Times, “The ad for Yaz was revised to more clearly state the indications for Yaz” (www.nytimes.com 9 February 2009, “A birth control pill that promised too much”).