Recalled Children's OTC Medications and Possible Charges against J&J Unit

The FDA is debating whether to seek criminal penalties against McNeil Consumer Healthcare, the Johnson & Johnson unit that manufactured the children’s Tylenol and other over-the-counter children’s medications that were recalled last month.

The possibility of criminal charges comes after Joshua Sharfstein, MD, the FDA's principal deputy commissioner, told lawmakers at a hearing Thursday that Johnson & Johnson has a “pattern of non-compliance” with good manufacturing processes. In regard to the possible charges against McNeil for the recent recall, Sharfstein told lawmakers that FDA regulators were considering such punitive measures as "seizure, injunction or criminal penalties," and an aide said that the criminal investigations office is looking into the validity of the recall and the actions of the company.

Sharfstein cited a September 2009 recall in which Johnson and Johnson removed 8 million bottles of children’s medications from the market because of a quality control issue. Also, in an undisclosed case from 2008, Johnson & Johnson learned of a possible problem with their Motrin pain reliever. However, instead of recalling the medication, the company hired a contractor who sent out people to buy up the product without first informing them what they were doing. These individuals were instructed to “simply act like regular customers… THERE MUST BE NO MENTION OF THIS BEING A RECALL," according to an instruction sheet obtained by House investigators" (Zajac, 5/28).

Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, was unaware of any instructions that consumers were given, but claimed that she did not think “there was any intent to mislead or hide” when she spoke to the House Committee On Oversight and Government Reform, according to the LA Times.

Goggins told the committee that no illnesses or deaths had been linked to the most recently recalled products, but authorities disclosed that there had been hundreds of adverse events, including 37 deaths since January 1, 2008, including seven since April 30, 2010. According to Sharfstein, however, the FDA has not determined that any of the deaths or adverse events was caused by the medications.

Johnson & Johnson is scheduled to reveal a plan for improving their manufacturing processes to the FDA by July 15.