Food and Drug Administration (FDA) regulators have written a letter warning drugmaker Bayer about quality control issues in the company’s plant in Berghamen, Germany. This plant is responsible for making drospirenone, the key ingredient for popular birth control drugs like Yaz and Yasmin; these products were Bayer’s top selling pharmaceuticals last year, with global sales of $1.8 billion. Instead of reporting individual tests results, FDA officials said the company measured the quality of its drug ingredients based on an average of several samples; Bayer shipped eight drug batches to the U.S. to be tested for quality using the sample average method, however the FDA does not allow this.
In April, Bayer responded to the FDA’s allegations by stating the quality in all drug batches shipped to the U.S. between 2007 and 2009 were not affected. In response, the FDA wrote another letter disagreeing with Bayer’s “rationale and conclusion.” While the FDA has not advised patients to stop using the products, they have asked Bayer to supply an entire list of all shipments to the U.S. that may have used the averaging method and provide a plan that would prevent the problem from recurring. The agency also said it was considering delaying imports from the German factory until Bayer addresses the warning letter.
New FDA Commissioner Margaret Hamburg has announced many changes designed to speed the pace of warning letters. This includes a streamlined review process for sending letters and shorter deadlines for companies to respond.
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