J&J: No written deal with FDA on 'phantom recall'

Congress demanded evidence, but Johnson & Johnson came up with fresh assertions that the FDA was aware of--and approved--a "phantom recall" of suspect batches of Motrin pills. In a letter to the House Committee on Oversight and Government Reform, J&J's lawyers contended that purchasing the defective painkiller off store shelves was perfectly legal, and that FDA was aware of it. But they didn't produce documentation of any agreement between J&J and the agency.

J&J delivered the letter in response to demands for proof that the company had negotiated a deal with FDA to "retrieve" the drug by stealth, rather than announce a public recall. J&J was not able to produce a written agreement: "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,'" wrote Ethan Posner and Robert Kelner, lawyers for J&J.

Instead, the attorneys pointed to internal emails referring to a "negotiated agreement," the same emails that touched off the latest controversy. They also submitted two reports made to FDA about the suspect Motrin, but as the Associated Press writes, those reports didn't include key details about the efforts to buy up the Motrin packets.

FDA still says it asked for a nationwide recall as soon as it learned of J&J's "soft market withdrawal," as the internal emails call it. And the agency points to its own documents for proof, namely an email that demanded the recall. "FDA then voiced its objections about McNeil's 'phantom recall' activities to senior leadership of Johnson & Johnson in a February 2010 meeting," the agency said in a statement. All this will be aired next week at the committee's hearing. 

- read the CNN Money coverage
- get the news from Reuters
- see the AP story
- find the post at Pharmalot

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