Did FDA know about J&J's 'phantom' recall?

The FDA's going to share Johnson & Johnson's pain, thanks to Rep. Darrell Issa, ranking Republican on the House Committee on Oversight and Government Reform. Issa wants to know just how much the FDA knew when J&J was in the throes of recalling iffy drugs.

The Wall Street Journal reports today on a group of emails that indicate J&J's McNeil Consumer Healthcare unit kept an FDA official in the loop when the company was planning to buy up defective Motrin rather than announce a recall. FDA tells the Journal that the emails were taken out of context--a familiar defense when documents like this surface--but, more substantively, that it didn't know about any "phantom recall" plans early on, and when it discovered that J&J had hired contractors to purchase the pills, it told the company to conduct a recall, which happened in July 2009. 

But the emails show McNeil staff chatting about their communications with FDA's San Juan, Puerto Rico, director Maridalia Torres, back in March and April. And one staffer told colleagues that Torres had agreed that the company could pull the questionable Motrin off store shelves without an actual recall. The company "negotiated an agreement" with FDA to that effect, the WSJ reports.

So, Issa asked Committee Chair Edolphus Towns to ask FDA to address the issue at the upcoming hearing, and Towns requested the presence of Joshua Sharfstein, deputy commissioner.

- read the WSJ piece

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