Lawmakers: No proof FDA OK'd phantom recall

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- Johnson & Johnson failed to prove that regulators had allowed a clandestine recall of defective Motrin products in 2009, lawmakers said Wednesday.

On Tuesday, a House committee investigating a string of recalls by Johnson & Johnson's McNeil drugmaking unit gave CEO William Weldon a Wednesday deadline to turn over evidence the Food and Drug Administration had OK'd a so-called phantom recall instead of a formal recall.

Ongoing investigations into McNeil revealed that McNeil conducted a phantom recall of more than 88,000 Motrin tablets in June 2009. Over the past year, McNeil has issued nine formal recalls of Tylenol, Motrin and Benadryl drugs.

Lawyers for Johnson & Johnson (JNJ, Fortune 500) told the Committee on Oversight and Government Reform that no document exists showing regulators had allowed the phantom recall, but maintained that the company had kept the FDA in the loop.

"It would be highly unusual for the FDA to negotiate an 'agreement' regarding the conduct of a recall in a formal manner, let alone a 'written agreement,' Ethan Posner and Robert Kelner, lawyers for J&J, said in a letter to the committee.

At the same time, they said that emails between company executives and FDA officials "make clear that McNeil kept the FDA apprised of its actions, including the planned assessment and retrieval of the Motrin caplets through the use of a contractor."

In one of those emails, dated May 27, 2009, and CC'd to McNeil president Peter Luther, a McNeil executive wrote:

"We have negotiated agreement with FDA not to formally conduct a recall for Motrin 8's but rather conduct a 'soft market withdrawal.' This is a major win for us as it limits the press that will be seen. We had committed to FDA to complete this withdrawal by July 15th."

J&J executives also told lawmakers during a congressional hearing about the recalls in May that the company did not try to hide its Motrin recall plans from the FDA.

Committee spokeswoman Jenny Rosenberg said the emails and and other documents received from Johnson & Johnson on Wednesday do not include a "negotiated agreement between J&J and the FDA."

For its part, the FDA maintains that after the agency learned of McNeil's effort, it prompted McNeil to initiate a nationwide recall of the Motrin tablets.

"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," the agency said in a statement Tuesday.

"When the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall which the company agreed to initiate in July 2009. FDA then voiced its objections about McNeil's 'phantom recall' activities to the senior leadership of Johnson & Johnson in a February 2010 meeting," the FDA said.

However, consumers never found out about the Motrin recall because McNeil/J&J never issued a press release about it.

The FDA could not immediately be reached for comment on the latest J&J assertions. To top of page

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