J&J’s Weldon will appear at next congressional hearing

pharmafile | September 21, 2010 | News story | Manufacturing and Production Johnson & Johnson, manufacturing compliance, recalls 

Johnson & Johnson chief executive William Weldon will appear in person at the next congressional hearing on the company’s wide-ranging recall of consumer healthcare products, according to the company.

The meeting on 30 September is focusing increasingly on what has been described as a ‘phantom’ recall of the company’s Motrin (ibuprofen) product in 2009, in which it is alleged that contractors hired by J&J systematically bought back supplies of the painkiller in order to avoid a public recall notice.

This week the Wall Street Journal claims it has uncovered new information about the Motrin case, including correspondence between J&J staff claiming that they had kept the FDA informed of the use of a contractor to buy back Motrin lots.

The US regulator has a different interpretation of the events and says it was unaware of the company’s actions.

The Motrin lots were made at J&J’s manufacturing facility in San Juan, Puerto Rico, and had a quality issue which meant they might not dissolve properly. One email obtained by the WSJ suggests that the objective was to limit press attention to the recall.

Meanwhile, questions have been raised about possible delays to J&J’s recall of a defective paediatric Tylenol (acetaminophen) product.   

Rep. Edolphus Towns, chair of the House Committee on Oversight and Government Reform which will conduct the hearing later this month, issued a statement recently asking whether J&J had been aware of the problems months before it actually issued an official recall and/or had been considering a phantom recall of the product.

The 30 September hearing will be the first time that Weldon will answer questions publicly about the recalls. FDA Deputy Commissioner Joshua Sharfstein has also been invited to attend.

Weldon was asked to testify before the committee at its first hearing in May, but said he was unable to attend because he was recovering from back surgery. Colleen Goggins, the worldwide chairman of Johnson & Johnson Consumer Group who attended in his place, said at the time the action was an audit to identify where the defective Motrin products were being sold. Goggins announced her retirement last week after 30 years with J&J.

The congressional hearing comes on the back of eight product recalls at J&J in the last 12 months affecting more than 136 million packs of various over-the-counter medicines, including not only Motrin and Tylenol but also the antihistamine Zyrtec (cetirizine) and cough medicine Benadryl (diphenhydramine).

Phil Taylor

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