May 17, 2002–Kenilworth, NJ–Schering-Plough Corporation says it has inked a consent decree with the U.S. Food and Drug Administration (FDA) regarding its ongoing issues with current Good Manufacturing Practices (cGMPs), at its facilities in New Jersey and Puerto Rico.

Under the terms of the agreement, the drug manufacturer will pay the US government $500 million; the first installment of $250 million is due by the end of the second quarter 2002, with the remaining to be paid in the second quarter 2003. Schering-Plough will also be required to hire "qualified outside experts in determining that manufacturing methods, procedures and controls at these production facilities comply with current GMP requirements," notes a company release.

"This agreement builds upon the efforts we have undertaken to date to resolve these manufacturing issues," said Richard Jay Kogan, CEO. "The company has worked closely and cooperatively with the FDA throughout this process and achieved two key objectives: keeping our plants open and operating, and continuing to make available our major pharmaceutical products to meet the needs of patients. We are confident of our ability to move forward under the agreement and complete our improvement programs successfully," Kogan adds.

The company will keep both locations up and running but will operate under strictly controlled conditions. In Puerto Rico, however, Schering-Plough said it would suspend the manufacturing of certain animal health products as well as some products that are not currently on the market. The agreement is subject to approval by the U.S. District Court for the District of New Jersey (Newark).