Schering-Plough Corp., Kenilworth, N.J., accepted a consent decree with the largest monetary settlement in Food and Drug Administration history--$500 million--to offset profits on drugs produced over the past three years at plants in New Jersey and Puerto Rico in violation of good manufacturing practice regulations, the FDA said. Schering-Plough and a subsidiary also agreed to make future payments of as much as $175 million if they fail to adhere to the FDA’s timeline for improvements. The consent decree is subject to court approval. The Schering-Plough plants involved produce about 90% of the firm’s drug products, and the consent decree affects about 125 prescription and over-the-counter drugs. As part of the decree, Schering-Plough agreed to suspend the manufacturing of 73 other products, the FDA said. The company said earnings projections for 2002 would be lowered as a result, but it achieved two key objectives through the consent decree: keeping its plants open and continuing to make its major pharmaceutical products available to consumers.
Schering-Plough to pay $500 million in deal with FDA
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.