By Andrew Zajac Tribune Newspapers
WASHINGTON A Pennsylvania drug plant plagued by quality-control problems that prompted a nationwide recall of children’s Tylenol and dozens of other widely used over-the-counter medicines drastically shrank its work force in recent years, according to local government tax records.
And a Food and Drug Administration inspection report this year cited failure to properly train contract and temporary employees as part of a lengthy catalog of quality control problems afflicting the plant – run by McNeil Consumer Healthcare, a subsidiary of pharmaceuticals giant Johnson & Johnson.
The troubled performance of McNeil and its parent company, once considered models for their industry, will be examined Thursday at a congressional hearing into what may rank as the biggest recall of pediatric medicines in U.S. history.
Manufacturing processes and staffing levels at the McNeil plant in Fort Washington outside Philadelphia are expected to come under special scrutiny.
The cutbacks at McNeil came amid other belt-tightening efforts throughout the $62 billion Johnson & Johnson global empire. Some critics have suggested the austerity measures may have gone too far and jeopardized safety and quality controls.
A McNeil spokesman declined to comment on employment levels at the Fort Washington plant or the products manufactured there. The company has suspended production at the Fort Washington facility until it can bring quality up to snuff and has hired an outside consultant to help with the process.
The FDA has received several hundred complaints of adverse events, including seven deaths, connected to the recalled products. But so far the FDA has not established a direct cause and effect between the medications and the adverse events.
The April 30 recall was the fourth involving Tylenol since last September. Earlier this month, the FDA announced an expansion of its investigation beyond the Fort Washington facility to include McNeil’s other plants, in Lancaster, Pa., and Las Piedras, Puerto Rico.
The Puerto Rico plant received a warning letter in January for tardy and inadequate handling of complaints about an odor on bottles of Tylenol that some consumers said sickened them.
In more bad news for Johnson & Johnson, the FDA disclosed earlier this week that it issued a warning letter in March to a company subsidiary, Advanced Sterilization Products, of Irvine, Calif., for failing to correct problems with sterilizing devices.
ASP said in a statement that it was taking steps to remedy issues raised by the FDA.
At McNeil’s Fort Washington location, the company sliced 478 jobs – roughly 100 jobs a year from the end of 2005 through the end of 2009, according to Whitemarsh Township tax records.
The cuts reduced the number of McNeil employees paying the local income tax to 998 from 1,476. The figures do not include an unknown number of employees who live in Philadelphia and don’t pay the local tax, township Finance Director Tom Mullin said.
A spokeswoman for the city of Philadelphia declined to release information on residents who work at the plant, citing taxpayer confidentiality.
While the reductions could reflect production shifted to other locations, the FDA inspection report specifically mentions a lack of training for a contract employee as well as for temporary workers – failings that point to substandard staffing levels, according to Albert Wertheimer, a professor of pharmacoeconomics at Temple University.
“That’s probably one of the causes of this,” Wertheimer said. “I would suspect it’s a matter of trying to get by with less, but in this case it didn’t work.”
Other deficiencies cited in the report included bacterial contamination of raw materials, shoddy equipment maintenance and failure to investigate 46 consumer complaints “regarding foreign materials, black or dark specks” stretching back almost a year before the recall.
The latter is especially troubling because even the best quality control can only sample a portion of a plant’s production, making swift investigation of consumer complaints critical, said Prabir Basu, managing director of the Advanced Pharmaceutical Technology Institute at Purdue University.
“There’s a basic lack of understanding of good manufacturing practice,” Basu said. “It’s a very sloppy operation.”
Staffing reductions at the McNeil plant were part of a workforce pruning throughout Johnson & Johnson, which until last year boasted of 76 consecutive years of revenue growth.
Total company employment dropped to 115,500 in 2009, down from 122,200 in 2006, and the company has announced plans to cut as many as 8,000 additional positions.
The questions about the safety and reliability of its products surprise many because the company has traditionally held itself to high ethical standards, and in particular, still wins plaudits for its handling of the 1982 Tylenol scare.
When seven Chicago-area consumers died after ingesting Extra-Strength Tylenol capsules laced with cyanide from an unknown source, Johnson & Johnson mounted a national recall of all Tylenol products, communicated directly with the public through its CEO and led an industry effort to develop tamper-resistant packaging.
The company’s response is still studied in business schools as a model of transparent and effective crisis communication.