J&J chairman addresses McNeil 'phantom recall' before House committee

WASHINGTON McNeil products soon will repopulate shelves, Johnson & Johnson chairman and CEO Bill Weldon shared on Thursday during his testimony before the House of Representatives Committee on Oversight and Government Reform.

The hearing was held to discuss the recent spate of McNeil recalls of certain infants’ and children’s products. “I know that we let the public down. We did not maintain our high-quality standards, and as a result, children do not have access to our important medicines,” Weldon said, pledging personally to see to fixing the quality concerns at McNeil.

The recalls were a precautionary measure, Weldon added, initiated despite the low risk as evaluated by the Food and Drug Administration had the products not been recalled. “It is important for consumers to know that the April 2010 recall was not undertaken on the basis of reports of adverse medical events. We recalled these products because of Johnson & Johnson’s commitment to consumers and its belief that the serious manufacturing issues it uncovered needed to be addressed even though the health risks to consumers were remote.”

Nonetheless, retailers can expect new shipments of a McNeil liquid pediatric product to reach their warehouses beginning next week. Weldon noted that as many as 1 million bottles will be part of that first rollout, and an additional 3 million bottles should be distributed by the end of 2010.

Regarding what the House committee has termed the Motrin “phantom recall,” Weldon also acknowledged that the company made a mistake in not including the FDA in its decision to “retrieve” eight-caplet Motrin products from the marketplace that were distributed primarily through the convenience store channel. Those caplets were being bought back by a third party under direction of McNeil because they “were found not to dissolve as quickly as intended,” as opposed to any safety concerns.

In closing, committee chairman Ed Towns, D-N.Y., suggested that the committee’s investigation into the J&J recalls was not concluded. “The testimony [today], combined with the testimony at our first hearing, indicates some very serious problems — both with the way Johnson & Johnson viewed its responsibility to the public and with its day-to-day relationship with the FDA,” he said.

Regarding the Motrin “phantom recall,” Towns said, “the evidence indicates J&J did everything it could to avoid a formal recall. In short, J&J tried to pull a fast one on the American public. I think it is fair to say this is not the last word on this investigation.”