WASHINGTON D.C. -- June 7, 2002 -- The drug manufacturer Schering-Plough has agreed to pay a $500 million fine because of quality control problems at its New Jersey and Puerto Rico plants (FDA News, May 17, 2002). The consent decree between the company and the Food and Drug Administration (FDA) represents the biggest monetary settlement in that agency's history.
Since 1998, the FDA has made 13 inspections at four of Schering-Plough's New Jersey and Puerto Rico plants, finding serious violations of good manufacturing practice regulations. These violations involved facilities, quality assurance, equipment, laboratories, packaging, and labeling.
Schering-Plough makes the popular allergy drug Claritin, as well as skin products, the hepatitis drug Rebetol, and asthma inhalers. Last year, the consumer watchdog group Public Citizen charged that the asthma inhalers were dangerously defective, and called for a criminal investigation of the company (see Deaths Caused by Defective Asthma Inhalers).
The current consent decree affects about 125 different prescription and over-the-counter drugs produced at the Puerto Rico and New Jersey facilities, which make 90% of Schering's drug products. As part of the decree, the company agreed to suspend the manufacture of 73 products. It also agreed to submit work plans for each facility, to make compliance reports to the FDA, and to hire independent quality control consultants who must make yearly inspections. The FDA will continue to periodically inspect Schering-Plough's manufacturing operations.
If you or a family member are concerned about prescription and over-the-counter drugs and your legal rights, please feel free to contact us at Brayton Purcell. We have extensive experience in medically-related litigation.