Recent Blog Posts in 2010

In early March, 2009, the FDA inspected Bayer's active pharmaceutical ingredient (API) facility in Bergkamen, Germany.  This is the plant that makes the key ingredient in Yaz and Yasmin, drospirenone.  The inspection revealed several deviations from U.S. current good manufacturing practices (CGMP). As a result, the FDA declared that Bayer had violated the Federal Food, Drug, and Cosmetic Act.  Under this Act, drugs manufactured in facilities that do not operate in accordance with CGMP are considered "adulterated." 

In its warning letter to Bayer, the FDA points out that Bayer "failed to establish and follow adequate written procedures for cleaning and maintenance of [production] equipment."  Additionally, the FDA expressed concern that Bayer had established deficient internal procedures for running its quality management system.  Investigators noted that Bayer measured the quality of its drugs, including drosperinone, by averaging the results of several samples, rather than reporting individual test results.  According to the FDA, this method for product sampling and testing amounted to an "unacceptable practice."  Concerned about releasing adulterated batches of drugs into the marketplace, the FDA demanded that Bayer take corrective action to conform to CGMP

On three separate occasions in 2003, 2008 and 2009, the FDA reviewed promotional and advertising materials for Yasmin and Yaz and in each instance concluded that the content of the materials was misleading. 

In 2003, the FDA sent a letter to Berlex Laboratories (the manufacturer of Yaz and Yasmin at that time) requesting the immediate removal of its 60-second TV ad for Yasmin.  The letter explains that the advertisement "misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone."  The letter then informs Berlex that "the FDA is aware of the added clinical risks associated with drospirenone…"

To read the FDA's 2003 letter to Berlex, click here.

Five years later, in 2008, the FDA warned Bayer that two of its TV commercials for Yaz were in violation of the Federal Food, Drug, and Cosmetic Act.  This time, the FDA explained that the ads "encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz."  Additionally, the warning letter points out that any risk disclosures contained in the commercials are countered by "distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information."

To read the FDA's 2008 warning letter to Bayer, click here.

Most recently, in a 2009 letter, the FDA again criticized Bayer's marketing practices, informing the drug manufacturer that its sponsored links for Yaz on internet search engines (such as Google) are misleading.  In this newest warning, the FDA not only mentions Bayer's inadequate communication of the drug's indications, but also cites Bayer's failure to communicate any risk information associated with the drug.