Weldon apologizes for recall problems, suggests “secret” recall was a mistake

By AP
Wednesday, September 29, 2010

J&J CEO says company “let the public down”

WASHINGTON — The chief executive of Johnson and Johnson will tell Congress his company “let the public down” with a string of quality problems that have resulted in millions of recalled medicines.

William Weldon is scheduled to testify Thursday morning before a House panel investigating the company’s unprecedented succession of recalls. The maker of trusted brands like Tylenol, J&J has announced nine product recalls since last September, with problems ranging from contamination with bacteria to tiny metal shards.

In prepared testimony obtained by The Associated press, Weldon also suggests the company made a serious mistake last year when it hired contractors to buy up bottles of defective lots of Motrin, rather than issuing a formal recall. The pills in question did not dissolve correctly.

“This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products,” Weldon states.

The so-called phantom recall is at the center of the investigation by the House Committee on Oversight and Government Reform. J&J executives insist the Food and Drug Administration was aware of the purchasing program, but FDA officials deny that claim.

But even as Weldon apparently criticizes the plan, his testimony suggests that the company made arrangements for a second phantom recall.

In the summer of 2009, Weldon says, J&J arranged with the same contractor to purchase bottles of defective Children’s Tylenol from retailers. Weldon states that the plan was cleared with the FDA.

“The FDA specifically approved visits to retailers, and it approved communications to retailers that described the use of contractors to purchase and remove the recalled products,” states Weldon’s testimony.

J&J ultimately announced a public recall of the product in September 2009.

Elsewhere in his remarks, Weldon says the company will start shipping liquid children’s cold medications next week. In May, J&J closed a Pennsylvania plant that makes most of those medicines.

In addition to Weldon, lawmakers will question J&J executive Colleen Goggins, who oversaw the consumer division of the company’s McNeil Healthcare unit during the recalls. J&J announced this month that Goggins will retire in March.

Also scheduled to testify is FDA Deputy Commissioner Joshua Sharfstein.

Since the committee’s last hearing on the matter in May, J&J and FDA have engaged in an increasingly shrill argument over the Motrin recall.

Documents provided to the committee by J&J attorneys seem to show that the FDA received a report in April about the effort to remove packages of the painkiller.

But FDA officials say the agency was unaware of the activity until May 2009, when the agency insisted the company conduct a formal recall.

According to committee staff, a J&J employee falsely told his supervisors that an FDA staffer in Puerto Rico had agreed to the company’s planned retrieval of Motrin from stores. The man’s claim, apparently accepted as true, was included in e-mail messages circulated among McNeil employees, according to the congressional staffers.

New e-mails released this week appear to detail J&J’s motivation for the secret recall. In a Jan. 29, 2009, e-mail obtained by The Associated Press, J&J employee Eddie Carrillo asks colleagues to send him a list of major retailers who received the defective Motrin.

“We are just trying to prevent a recall and a lot of expended $,” writes Carrillo. “That’s why your quick response will be appreciated.”

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