Oversight Committee Invites FDA, J&J Execs to Tylenol Recall Hearing


The Chairman of the House Committee on Oversight and Government Reform, Edolphus Towns (D-N.Y.), has invited Food and Drug Administration Principal Deputy Commissioner Dr. Joshua Sharfstein to testify during another hearing regarding Johnson & Johnson (JNJ)'s massive recall of over-the-counter children's medicine. Last week, Towns invited company execs to testify in the hearing scheduled for Sept. 30, 2010.

The committee hearing is set to examine J&J's recall of over 135 million bottles of infant and children's medicines, including Children's Tylenol, Infant's Tylenol, Children's Motrin and Children's Benadryl. The products were produced by J&J's unit McNeil Consumer Healthcare.

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The hearing will also specifically examine the "phantom recall" of a Motrin product, during which company contractors secretly repurchased all available Motrin products from pharmacy shelves. The actions became public as a result of the committee's earlier hearing on May 27, 2010.

Towns is asking the FDA to provide the committee with copies of its records relating to the phantom recall of Motrin, including all communications between the company and the FDA from January 2009 to June 2009. Last week, Towns released several internal company communications and emails from the subcontractor that carried out the phantom recall. One of the emails from the president of McNeil, dated May 27, 2009, reads:

As you know we have negotiated agreements with FDA not to formally conduct a recall of Motrin 8's but rather conduct a "soft market withdrawal". This was 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.

Did J&J Know About Problems with Children's Tylenol Months Before the Recall?

In the letter inviting J&J Chairman and CEO William Weldon, Towns expressly mentions this email, saying Weldon will have to discuss how the "president of Johnson & Johnson's McNeil subsidiary appears to approve the phantom recall of certain adult Motrin." Towns adds this raises serious questions about top level managers at a company that is the largest producer of children's medicines. Another email from June 2009, mentions a Children's Tylenol recall, but that wasn't announced until April 2010. Towns asks if the company knew about the problems months before.

Towns also invited Colleen Goggins, the worldwide chairman of J&J consumer group, to testify. Goggins testified in the previous hearing. But not long after news of the hearing last week, J&J announced Goggins would be retiring effective March 1, 2011. In the letter inviting Goggins, Towns wrote: "You testified that you were not aware of the behavior of the contractors who conducted the phantom recall. However, after that hearing the Committee obtained a Johnson & Johnson//McNeil document that instructed the contractors how to behave while conducting the phantom recall. Please be prepared to discuss this apparent inconsistency at the September 30, 2010 hearing."