FDA Warns Bayer About Problems with Yaz and Yasmin Drug Plant

An FDA warning letter to Bayer indicates the drug maker has substantial problems at a plant in Germany with the manufacturing process for their popular Yaz and Yasmin birth control pills. The company failed to adhere to good manufacturing practices for key ingredients in Yaz and Yasmin, and the FDA indicates that the drug maker hid data that should have prevent several batches of drugs from being shipped to the United States.

Bayer Pharmaceuticals received the letter last month, which was released on the FDA website this week, detailing the findings of an FDA inspection of a Bayer manufacturing plant in Germany that produces drospirenone, a key active ingredient in Yaz and Yasmin oral contraceptives.

FDA inspectors say that their review of the facility found “significant deviations” from good manufacturing practices on active pharmaceutical ingredients (API), and accuses the drug maker of hiding results that showed some patches of the drug were outside the company’s specifications.

Bayer is accused of using improper “averaging,” by taking out-of-specification (OOS) test results, diluting them with good test results and then reporting the average instead of reporting instances where the quality of the active ingredients deviated outside of the realm of set parameters. The FDA letter says the OOS batches “should not have been released for distribution.”

“The hiding of an OOS result in the average is an unacceptable practice,” the FDA letter states. “We remain concerned with your release and distributed API batches used in the manufacture of finished products intended for the U.S. market.”

The inspection took place in March, and Bayer responded to the initial inspection in April with a letter that said the company believes it acted properly in averaging bad batches of drugs with good ones before reporting the overall results to FDA. The company also said it believed that there were no problems with Yasmin and Yaz drug batches that were released.

The FDA disagrees with the company’s rationale, conclusions and belief that the quality of the released batches was unaffected. It is requiring Bayer to turn over a list of all active ingredient batches shipped to the U.S. that used averages that included OOS test results, in what some anticipate may lead to a limited Yaz and Yasmin recall. It also is requiring Bayer explain how it plans to bring its practices in line with FDA’s interpretation of federal guidance.

The inspection results are the latest in a series of problems with Yaz and Yasmin for Bayer. There are a growing number of lawsuits over Yaz and Yasmin, which accuse the drug maker of failing to adequately warn about alleged side effects of the birth control pills, including the increase risk of heart attacks, strokes, deep vein thrombosis (DVT), pulmonary embolism (PE), gallbladder disease and sudden death.

Bayer currently faces about 50 lawsuits over Yasmin or Yaz in federal court, and a hearing is scheduled next week to determine whether all of the cases should be centralized and consolidated under one judge for pretrial litigation as part of an MDL, or Multidistrict Litigation.

Yasmin and Yaz lawyers are currently reviewing hundreds of additional cases on behalf of women who have experienced problems with the birth control pills, and it is expected that the number of lawsuits against Bayer will exceed 1,000 within the next year.

The FDA has issued at least three other warnings regarding problems with Yaz and Yasmin marketing and advertisements, which contained false and misleading statements about the risks and benefits of the drugs. Those warning letters indicated that the drug maker made exaggerated claims about the drugs’ benefits and downplayed important information about potential side effects of Yasmin and Yaz.

As a result of pressure from the FDA and states attorneys from several states, Bayer agreed to spend $20 million on a corrective advertising campaign.