US House keeps heat on J&J recalls as top exec retires
This article was originally published in Scrip
Colleen Goggins, Johnson & Johnson's longtime senior executive in charge of the consumer group, will be retiring from the company next March. The announcement was made just hours after a US House committee disclosed plans to hold a hearing on 30 September to once again interrogate J&J executives about the massive recall earlier this year of 136 million bottles of children's OTC medicines, due to quality control issues.
The lawmakers have increasingly focused on the company's actions surrounding a plan to hire outside contractors to buy back defective Motrin from several thousand convenience stores in what they termed a "phantom recall" – the details of which only became available during an initial hearing earlier this year (scripintelligence.com, 2 June 2010). It was at that hearing that Ms Goggins testified that there was no attempt to hide anything from the FDA. The committee later expanded its probe on the phantom recall issue (scripintelligence.com, 8 June 2010).
Representative Edolphus Towns who heads the House Committee on Oversight and Government Reform, said the need for another hearing has arisen due to "extremely troubling" information which has been uncovered since the first hearing. Previously, the committee had looked at several aspects of the company's conduct on the recalls. Representative Towns emphasised in his hearing announcement statement that he was releasing internal J&J emails about the "phantom recall" on Motrin and from the contractor who carried out the work.
The committee sent letters to J&J CEO Bill Welldon and Ms Goggins, inviting them to the hearing. "Was J&J considering conducting a phantom recall of children's medicine?" was one of the questions that Towns asked in the Weldon letter. Another one was, "Was J&J aware of problems with Children's Tylenol and other children's medicines months before it actually recalled these products?"
Ms Goggins testified in May after Mr Weldon said he could not attend because he was recovering from back surgery. In the letter to Ms Goggins, Representative Towns questioned the accuracy of her testimony. "You testified that you were not aware of the behaviour of the contractors who conducted the [Motrin] phantom recall," he wrote. "However, after that hearing the Committee obtained a J&J/McNeil document that instructed the contractors how to behave while conducting the phantom recall."
Mr Weldon told the New York Times that the company has in place a plan to address the problems at McNeil. He also stated his intention to appear at the upcoming hearing, stating, "I will definitely testify…I wanted to testify at the last one."
J&J's McNeil unit is being investigated by both the oversight committee and the FDA for the massive recalls. The McNeil facility in Fort Washington, Pennsylvania has been closed since late April after FDA inspectors found serious GMP problems, which included the company failing to meet its own specifications for bacteria in raw material lots or for particulates, and for one Tylenol product the possibility of higher than expected concentrations of Tylenol per dropper.
In January, the company recalled lots of different OTC medicines that may have been contaminated with a chemical found on the packaging materials. Last month, Mr Weldon began giving interviews in which he acknowledged that the firm has to regain the trust of J&J customers. He has emphasised the hiring of third party experts, plans to invest more heavily in upgrading other McNeil facilities, and putting company veteran Ajit Shetty in charge of a corporate oversight group on quality and compliance issues, giving him responsibility for manufacturing operations for the company's pharmaceuticals, medical device and consumer segments.
Ms Goggins has been chairman of J&J's worldwide consumer group for more than a decade and sits on the company's executive committee.
The plant in Fort Washington is to be overhauled as part of a plan submitted to the FDA for fixing problems at the troubled plant (scripintelligence.com, 19 July 2010).
While J&J may have to repair its reputation with consumers, portfolio managers have shrugged off the recalls and plant problems so far, saying that the financial hit is relatively modest considering the company's overall yearly sales.