Congress, lawyers dig deeper with FDA and J&J over product recalls

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Investigators and Congress are turning up the heat on Johnson & Johnson.  The company’s widespread product recalls have been well documented.  However, details are beginning to emerge as to how J&J managed the crisis.

Apparently, J&J’s preference was to quietly remove defective products from store shelves.  They executed this plan through private contractors hired to buy up entire store inventories as  ‘customers’ rather than issue a formal public recall.  However, now there is a debate as to whether the FDA knew about it.

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:  “We have negotiated agreement with FDA not to formally conduct a recall for Motrin but rather conduct a ‘soft market withdrawal.’ This is a major win for us as it limits the press that will be seen.”

On Tuesday the FDA issued a statement again maintaining that the agency was not aware of and had not signed off on McNeil’s “phantom recall” of Motrin.  J&J executives, led by Consumer Head Collen Goggins, told lawmakers during a Congressional hearing  in May that the company did not try to hide its Motrin recall plans from the FDA.   Mrs. Goggins has since announced her retirement and departure from the company.

So what’s next?  Late Tuesday, the committee requested that J&J deliver a copy of an alleged agreement between McNeil and the FDA that permitted McNeil to forego a formal recall of the Motrin product and instead conduct a ‘soft market withdrawal.’  J&J CEO William Weldon, was given until Wednesday to provide the proof.   Lawyers for J&J responded late last night that no formal documents exist to validate such a claim but that normal FDA practices would not require such documentation.  Simply put, both J&J or FDA are in the crosshairs of Congressional investigators as their stories conflict.

This story is far from over and big questions are looming from those across the industry.  Will any criminal charges stem from this investigation?  Will Weldon be called to Capitol Hill to testify?  And can he survive as CEO of J&J as more details come to light?

As a point of reference, we are reposting Weldon’s last TV interview led by Mario Barturomo from CNBC during which they discuss the recall.


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