J&J executive retires amid recall hearing
The head of the division of Johnson & Johnson responsible for most of its 11 product recalls announced her retirement Thursday, shortly after House Committee on Oversight and Government Reform invited her to a second hearing regarding the recalls.
J&J, which in 2009 recalled more than 135 million bottles of infants' and Children's Tylenol and products like Children's Motrin and Children's Benadryl, announced that Colleen Goggins will retire on March 1 after almost 30 years at the company, according to The Associated Press.
The company released the news shortly after the committee announced the second hearing, inviting J&J Chief Executive Officer William Weldon, who sent Goggins in his place to the panel's first hearing in May, according to the AP. Goggins was also invited to the Sept. 30 hearing.
The committee released internal J&J e-mails it uncovered demonstrating that before the official recalls the company conducted a "phantom recall" over the last year, of Motrin packages, according to the AP.
One e-mail written on May 27, 2009, by an executive at J&J's McNeil Consumer Healthcare unit to five colleagues indicates that J&J paid a third party to quietly remove the Motrin packets off store shelves, apparently with the permission of the Food and Drug Administration.
"As you know, we have negotiated an agreement with FDA not to formally conduct a recall for Motrin ... but rather conduct a ‘soft market withdrawal.' This was a major win for us as it limits the press that will be seen," reads part of one e-mail chain released by the House committee's chair, Rep. Edolphus "Ed" Towns, D-NY.
Also, according to a document from a May 2009 hearing on the committee's website, McNeil asked a third party to purchase the Motrin products from all vendors without mentioning the recalls.
"You should simply ‘act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product! If asked, simply state that your employer is checking the distribution chain of this product and needs to have some of it purchased for the project," according to the document.
But Jenny Rosenberg, a staff aide on the House committee, told the AP there was no evidence that the FDA approved the phantom recall, and FDA spokeswoman Elaine Gansz Bobo told the AP she had no information about the issue.
"It's still an ongoing investigation," Bobo said.
J&J declined to comment.
"We're not giving any comments about [the case], but we do plan on attending the hearing," said J&J spokesman Bill Price.
According to the FDA, 88,104 packages of the Motrin IB 200 were released in August 2008, and the problem was identified that November.
The FDA has cited several issues with J&J in the past, which is reflected in the May 2010 hearing.
FDA investigators identified several problems before 2009 with the Good Manufacturing Practices' particle counting requirements compliance at facilities run by McNeil, including laboratory controls, equipment cleaning processes and a failure to investigate identified problems, Principal Deputy Commissioner of FDA Dr. Joshua M. Sharfstein, said in a statement at the hearing. The company fixed the problems, and it was inspected regularly.
But the FDA identified several other cGMP violations in May and June 2009, including McNeil's failure to meet its own standard for quality in one of the ingredients in over-the-counter medications, Sharfstein said.
McNeil's standard for this ingredient, known as microcrystalline cellulose, required that there be no gram of negative bacteria, and McNeil purchased the cellulose in partial lots that had not tested positive for this bacteria, he said.
"The vendor tested other partial lots from the same large master lot and found a certain gram of negative bacteria called B. cepacia," Sharfstein said. "According to cGMP standards, McNeil should not have used any partial lots for this master lot."
He said while the risk to the public was not as serious, the company still violated a standard.
In her testimony in May, Goggins apologized for the recalls.
"The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable," she said. "On behalf of McNeil and Johnson & Johnson, I apologize to the mothers, father and caregivers for the concern and inconvenience caused by the recall."
During the hearing, the committee also questioned the FDA's ability to enforce mandatory recalls.
"One thing that we know now is that the FDA needs mandatory recall authority. They shouldn't have to persuade a company to recall and suspect products," Towns said. "I intend to introduce legislation to give FDA that authority. FDA should also have the power to order a halt in drug production."