By Mike Lillis - 09/23/10 04:40 PM EDT
The drug giant that manufacturers Motrin confirmed this week that Food and Drug Administration (FDA) officials knew about the company's "phantom recall" of defective pills.
The concession drew immediate criticisms from Rep. Darrell Issa (Calif.), senior Republican on the House Oversight Committee, who said he has "growing concerns" about the close ties between the agency and McNeil, a subsidiary of Johnson & Johnson that makes the popular over-the-counter pain killer.
"We need to uncover the true extent of what the FDA knew and when they knew it and determine whether or not they acted appropriately and timely," Issa said in a statement.
The so-called "phantom recall" of Motrin began in 2009, when McNeil hired private contractors to buy up defective Motrin from retailer shelves, rather than initiating a national recall, which would have brought a great deal of unflattering attention to the company.
"Run in, find the product, make your purchase and run out," the contractors were instructed. "There must be no mention of this being a recall of the product."
The issue has raised eyebrows from lawmakers on both sides of the aisle, with Issa and Rep. Edolphus Towns (D-N.Y.), chairman of the House oversight panel, leading the charge. And their focus has shifted in recent weeks from questions of why McNeil didn't initiate a quicker recall, to why FDA didn't push harder for one.
In a letter to the committee released Wednesday, McNeil attorneys said there was never a written agreement between FDA and the company over the stealth recall, but the agency knew about it nonetheless.
"Although no one from McNeil, to our knowledge, has stated to the Committee that there was a formal written agreement with the FDA," the lawyers wrote, "the contemporaneous documents do make clear that McNeil kept the FDA apprised of its actions, including the planned assessment and retrieval of the Motrin caplets through the use of a contractor."
Issa says the absence of a formal agreement is inconsequential.
"McNeil was obviously under the impression that they had successfully negotiated an agreement with the FDA to not designate their actions as a national recall," he said. "There is a clear disconnect between what the FDA has told us and what McNeil has asserted – it’s our job to reconcile that and reform any areas within the bureaucracy that failed to communicate or take appropriate action."
The oversight panel has scheduled a Sept. 30 hearing on the issue, including testimony from leaders of McNeil, Johnson & Johnson and the FDA.