- March 1 - 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-Ploughs Kenilworth, N.J., plant, and that more
recently, FDA inspectors who visited the plant found that similar manufacturing problems
Auditors of AAC Consulting Group of Rockville, Md., visited Schering-Ploughs
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 Citizens Health
Research Group. "The auditors essentially found that the practices at the plant are
so poor that theres 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."