Towns, Issa Announce Investigation into Recall of Popular Pediatric Medication

May 5, 2010

WASHINGTON DC– Chairman Edolphus “Ed” Towns (D-NY) and Ranking Member Darrell Issa (R-CA) today announced that the committee has opened an investigation into the circumstances surrounding a major recall of children’s medication.  McNeil Consumer Healthcare (a subsidiary of Johnson & Johnson), the manufacturer and marketer of well known over-the-counter and prescription pharmaceuticals including Children’s Tylenol, Infants’ Tylenol and Children’s Motrin, recently announced a voluntary recall of more than 40 over-the-counter medications as Food and Drug Administration (FDA) inspectors were completing a nearly two-week long inspection of the facility where the medication is produced.

Towns and Issa want to bring attention to the recall particularly due to the fact that children could be adversely impacted if they were to take any of the medicine that was covered by the recall.  The oversight leaders are seeking clarification on the recall based on a Washington Post article that contains conflicting accounts about the existence of raw materials in the medication and the significance of their contamination effect.  FDA and McNeil Consumer Healthcare have given conflicting accounts of the circumstances surrounding the recall, including what prompted the recall and how serious the recall is.  In addition, as this is the third recall of Tylenol products in less than a year, the lawmakers are questioning the adequacy of FDA’s inspection procedures and whether McNeil failed to investigate consumer complaints that could have identified the contamination problems.

Chairman Towns and Ranking Member Issa said, “We are deeply concerned about the recall of popular pediatric medications widely used by infants and children across the country.  When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.  In the coming days we will be asking both McNeil Consumer Healthcare and the FDA to provide this committee with information about the recall and we expect a hearing will follow in the coming weeks.  This is an issue we cannot afford to ignore.”

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