J&J chief admits mistakes at Congressional hearing
pharmafile | October 1, 2010 | News story | Sales and Marketing |Â Â Johnson & Johnson, manufacturing compliance, recallsÂ
Johnson & Johnson chief executive William Weldon admitted yesterday that his company had failed to maintain quality standards and mishandled recalls at its subsidiary McNeil Consumer Health.
Speaking in front of a congressional committee convened to investigate the circumstances behind the recall of an estimated 135 million over-the-counter medications, Weldon said he accepted full responsibility for the quality lapses, whilst announcing a $100 million investment programme to help set the company’s manufacturing operations to rights.
Regarding the so-called ‘phantom recall’ of Motrin (ibuprofen) – in which contractors hired by J&J systematically bought back supplies of the painkiller in order to avoid a public recall notice – Weldon said that the company “made a mistake,” and failed to keep the FDA fully informed about its actions.
“This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products,” Weldon said, while Colleen Goggins, the company’s director of consumer health, said: “were we to do this over, we certainly would be more transparent.”
The FDA has stepped forward to share some of the blame though. The US regulator’s deputy director Joshua Sharfstein told the hearing that the agency should have been more efficient at identifying what was going on and encouraging J&J to initiate a recall.
Sharfstein also took the opportunity to reiterate that the FDA should be given a mandate to order product recalls, a power which it does not possess at present.
Johnson & Johnson estimated its recalls will cost $600 million in lost revenues, equivalent to 1% of its total sales of approximately $60 billion a year. One product involved in the recall – a paediatric formulation of Tylenol (acetaminophen) – is due to return to the market next week.
“We recognise that we need to do better, and we will work hard to restore the public’s trust and faith in Johnson & Johnson,” said Weldon.
Phil Taylor
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