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Johnson & Johnson's Headache

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Washington, DCOn the heels of its recall of 40 nonprescription drugs for children, including Tylenol and Motrin, Johnson & Johnson may face criminal charges due to failure of good manufacturing principles, lack of quality control and possibly deceptive practices.

The New York Times reported that The FDA is "considering additional enforcement actions against the company for its pattern of noncompliance, which may include seizures, injunction or criminal penalties," Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, said during a Congressional hearing called by the House Committee on Oversight and Government Reform. The hearing was called to determine whether the FDA had responded adequately to last month's recall, including Childrens Tylenol and Childrens Motrin, and to also examine the circumstances that prompted the recall.

Evidence at the hearing showed that the quality and process issues found at McNeil-—a unit of J&J, "are unacceptable", said Colleen A. Goggins, the worldwide chairwoman of Johnson & Johnson's consumer group. One New York democrat, Representative Edolphus Towns, took that criticism one step further and said, " It paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk."

The gigantic drug manufacturer has a history of problems and consumer complaints. Deputy Commissioner Joshua Sharfstein testified before the hearing that the FDA was aware of problems for at least a few years, and apparently the issues were resolved. But in 2009 the FDA again found problems and accused J&J of "failure to meet its own standard for quality."

Manufacturing and quality problems led to the recall on April 30 that included more than 136 million bottles of liquid children's drugs, including Tylenol, Motrin and Benadryl. The medications may have contained inactive ingredients that failed testing, bits of metal or too much active ingredient. But that isn't the reason why J&J has been referred to the FDA's office of criminal investigation, which works with the Justice Department to prosecute companies accused of violating the laws governing drug manufacturing and marketing.

Rather, McNeil has come under fire regarding its conduct surrounding several previous recalls. In 2008 McNeil "quietly removed" Motrin from retailers because of suspected problems without informing the FDA,
The action "paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk," said Rep. Edolphus Towns, committee chairman, as reported by The Times.

Johnson & Johnson has suspended production at McNeil's Fort Washington, Penn., plant that manufactured the recalled children's products.



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