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J&J’s “Phantom Recall” and Communication with FDA Probed During House Hearing

Oct 4th, 2010

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Johnson & Johnson’s “phantom recall” of subpotent Motrin and its communications with FDA were focal points at a US House of Representatives Committee on Oversight and Government Reform hearing on September 30.

The hearing was a follow-up to a previous committee hearing in May that examined the details surrounding the late-April recall of more than 135 million bottles of Children’s Tylenol and other popular pediatric medicines produced by J&J’s McNeil Consumer Healthcare division at its Fort Washington, Pennsylvania facility.  The recall followed an FDA inspection that resulted in McNeil ceasing production at that facility while pursuing corrective actions (IPQ “In the News” September 23).

The follow-up session was prompted by questions left unresolved at the May hearing and additional information subsequently received by the committee.  The committee continued to probe into J&J’s handling of problem products produced at its Fort Washington and Las Piedras facilities between 2008 and 2010 and the interactions between J&J and FDA around them.  Among the concerns was how much FDA knew about the approach J&J was taking in its “phantom recall” of April 2009 involving subpotent motrin lots produced at its Las Piedras facility.

The hearing was comprised of two panel sessions.  Appearing at the first session were J&J’s CEO William Weldon and Consumer Group Worldwide Chairman Colleen Goggins.  The second session was an interview with FDA Principle Deputy Director Joshua Sharfstein.

The first panel began with opening statements by committee chair Edolphus Towns (D-NY) and four committee members.  J&J’s Weldon and Goggins followed with prepared statements in which they acknowledged that “mistakes” were made during the withdrawal/recall process.  In the Q&A that followed, each of the committee members had about five minutes to interview Weldon and Goggins.

In his opening statement, Towns recapped what was learned at the May hearing and pointed to documents uncovered by the committee since that time that he asserted call into question testimony during the first hearing that J&J senior management was unaware of the particulars surrounding the “phantom recall.”  The committee chair added that “J&J has said that FDA knew about and approved the phantom recall, but the FDA says that isn’t true.  Both sides will have an opportunity to tell their sides of the story today.”

[More on the hearing and links to relevant documents are provided for subscribers beginning on page 2.  For subscription, information click here.]

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