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Panel Asks if FDA Knew About Secret J&J Recall

Wednesday, 22 Sep 2010 10:02 AM

A U.S. House committee probing recent massive recalls of Johnson & Johnson consumer medicines wants to know if the U.S. Food and Drug Administration last year permitted the company to secretly recall potentially tainted stocks of its Motrin painkiller.

The House Committee on Oversight and Government Reform on Tuesday said it had obtained an email in which an executive of J&J's McNeil consumer medicines unit described an agreement with the FDA authorizing J&J to conduct an unpublicized recall of adult Motrin.

The committee said the agreement purportedly allowed McNeil to forgo a publicly announced formal recall of the Motrin product and to instead conduct a "soft market withdrawal."

The committee for months has been examining what it describes as the "phantom recall" of Motrin, in which contractors quietly bought up stocks of the painkiller from store shelves.

The committee on Tuesday released a copy of a May 27, 2009, email from a McNeil executive to numerous colleagues, which cites a negotiated agreement with the FDA consenting to an unofficial recall of Motrin.

"This was a major win for us as it limits the press that will be seen," the email said, adding the company had promised the FDA to complete the informal recall by July 15.

Committee Chairman Edolphus Towns, in a letter sent Tuesday to J&J Chief Executive Bill Weldon, requested that J&J provide him by Wednesday with a copy of any alleged agreement with the FDA for a phantom recall of Motrin.

"We've been cooperating with the committee and will respond accordingly," a J&J spokesman said.

But FDA spokeswoman Elaine Bobo late on Tuesday said her agency was unaware of McNeil's "phantom recall" when it was initiated last year. "Any effort to suggest to the contrary is based on quoting documents selectively and out of context and ignores other evidence as to what occurred," Bobo said.

"McNeil's own written account of its communications with FDA does not support the conclusion that McNeil disclosed the activities associated with its 'phantom recall' to FDA."

The FDA, when it learned McNeil had hired contractors to secretly purchase product off the shelves, advised the J&J consumer unit "to do a full recall, which the company agreed to initiate in July 2009," Bobo said. "(The) FDA then voiced its objections about McNeil's 'phantom recall' activities to the senior leadership of Johnson & Johnson in a February 2010 meeting."

The House panel last week scheduled another hearing for Sept. 30 on J&J's repeated recalls of Tylenol, Motrin and other over-the-counter medicines in the past year.

Quality control problems at J&J plants that sparked the recalls have tarnished the company's reputation and forced the closure of a big company factory in Ft. Washington, Pennsylvania. Colleen Goggins, longtime head of the McNeil unit, retired on Sept. 16, just hours after the House committee disclosed potentially damaging new information about the recalls.

The committee said it now has reason to believe J&J may have considered a second "phantom" recall — this time for Children's Tylenol — almost a year before McNeil's April 30, 2010 formal recall of 135 million bottles of children's formulations of Tylenol, Motrin and allergy treatment Benadryl.

© 2017 Thomson/Reuters. All rights reserved.

   
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A U.S. House committee probing recent massive recalls of Johnson Johnson consumer medicines wants to know if the U.S. Food and Drug Administration last year permitted the company to secretly recall potentially tainted stocks of its Motrin painkiller. The House Committee...
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2010-02-22
Wednesday, 22 Sep 2010 10:02 AM
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