Possible criminal investigation for Tylenol maker

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McNeil Consumer Healthcare

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. “On behalf of McNeil and Johnson & Johnson, I apologize to the mothers, fathers, and caregivers for the concern and inconvenience caused by the recall.”

As a direct response to the recall, the New York Times noted that the company had replaced some executives and was conducting “an overhaul of its manufacturing and quality control processes.”

Sharfstein testified that, so far, no serious illnesses from the recalled products have been reported, but expressed concern over McNeil’s unsatisfactory response to nearly 50 consumer complaints about their products, including the presence of foreign particles. He also pointed out that as far back as 2008, consumers complained of the moldy smell and reported some stomach problems after using some products made from the company’s Puerto Rico plant, but that the McNeil did not notify the FDA until the following year.

Since April 30, millions of bottles of children’s Tylenol, Motrin, Zyrtec and Benadryl in various flavors and formulations have been recalled, but Sharfstein reassured the public that medications currently on sale are safe.

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