Possible Criminal Investigation For Tylenol Maker
by ilene - May 30th, 2010 4:00 pm
Possible Criminal Investigation For Tylenol Maker
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By Alice Park, courtesy of TIME
Things just seem to be getting worse for Johnson & Johnson and one of its branches, McNeil Consumer Healthcare. After a routine inspection by the Food and Drug Administration (FDA) of a McNeil plant in Pennsylvania found serious lapses in quality control — including bacterial contamination and lack of proper evaluation of a drug’s potency — the company voluntarily recalled several over-the-counter children’s medications for colds and allergies in April.
Now, after an investigation by the FDA into McNeil’s manufacturing practices, the agency has decided to refer the case for further review to the FDA’s law enforcement arm for possible criminal action.
The House Committee on Oversight and Government Reform convened a hearing on Thursday to investigate the latest recall, since it wasn’t the first for the company this year. In January, the company recalled some of the same children’s products — children’s Motrin, children’s Tylenol and Benadryl, as well as others, including Extra Strength Tylenol for adults — because of a moldy smell coming from the medications. The odor apparently came from a chemical that coats the wooden pallets used to move and store the product packaging materials.
In testimony on Thursday, the FDA’s principal deputy commissioner Dr. Joshua Sharfstein noted that the agency may seek criminal charges for J&J for its failure to comply with safe manufacturing practices as well as its failure to act responsibly in addressing problems. As reported in the New York Times:
During a session in which some committee members questioned McNeil’s integrity, Dr. Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil had hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the F.D.A.
“This is something troubling to the agency,” Dr. Sharfstein said. “We think it reflected poorly on the company.”
Colleen Goggins, the worldwide chairman of J&J’s consumer group, confronted the accusations of poor quality control and admitted the lapses, as ABC News reported:
"The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable," she said.
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Philip R. Davis is a founder Phil's Stock World, a stock and options trading site that teaches the art of options trading to newcomers and devises advanced strategies for expert traders...
Ilene is editor and affiliate program
coordinator for PSW.
