March 1, 2001
FDA Should Investigate Sloppy Manufacturing Practices at Drug Maker Schering-Plough, Public Citizen Says
Confidential Audit, FDA Inspection Uncover Problems at Kenilworth, N.J., Plant
WASHINGTON, D.C. ? Public Citizen is urging the U.S. Food and Drug Administration (FDA) to investigate quality control problems at a New Jersey plant owned by pharmaceutical giant Schering-Plough.
In a letter sent today to Department of Health and Human Services Secretary Tommy Thompson, Public Citizen urges the FDA to look into manufacturing practices associated with asthma inhalers and other drugs. During the past 15 months, the drug manufacturer has been forced to recall 59 million asthma inhalers because many units lacked the active ingredient.
Documents obtained by Public Citizen show that external auditors last year found significant problems at Schering-Plough?s Kenilworth, N.J., plant, and that more recently, FDA inspectors who visited the plant found that similar manufacturing problems still existed.
Auditors of AAC Consulting Group of Rockville, Md., visited Schering-Plough?s Kenilworth plant between Feb. 28, 2000, and April 14, 2000. They were extremely critical of the general attitude of managers, who told them about “an imbalance between quality and production, leaning considerably toward production.”
The problems with the inhalers indicate “insufficient technical expertise and managerial oversight,” the auditors wrote.
Meanwhile, in a recent 31-day FDA inspection of the same facility, which was completed on Jan. 19, inspectors found similar quality control problems and concluded that “[t]he process validation for many products fails to support claims that manufacturing processes were capable of consistently producing products with the same quality, purity, and safety.”
The problems found by the FDA inspection are so serious that some production lines have been temporarily halted and the company will not be allowed by the FDA to gain approval of or start shipping Clarinex, its new allergy drug, as planned. FDA investigators found “no assurance that the manufacturing process, parameters, equipment or protocols . . . conducted at multiple sites for the production of Clarinex . . . are equivalent or capable of producing product of the same quality.”
In the letter, Public Citizen asks the FDA to consider whether criminal charges are warranted because of the possibility that the company was aware of the quality control problems when it shipped some of the defective inhalers. The FDA also should investigate the drug manufacturer for continuing to ship other prescription drug products while aware of the manufacturing problems, Public Citizen wrote.
“The practices uncovered are dangerously sloppy and threaten the health of consumers,” said Dr. Sidney M. Wolfe, director of Public Citizen?s Health Research Group. “The auditors essentially found that the practices at the plant are so poor that there?s no guarantee that drugs have the right amount of active ingredients, or that they are manufactured consistently enough to ensure that they contain what they purport to contain. This is no way to run a drug company.”