In the latest twist in the Johnson & Johnson recall scandal, a high-priced law firm writes Congressional investigators that the FDA was "fully apprised" of a hush-hush effort to yank Motrin from store shelves, rather than announce a typical product recall. At the same time, though, the J&J lawyers concede there is no proof that an agreement actually existed to prove the FDA gave its blessing to what a Congressman is derogatorily calling a "phantom recall."
The health care giant, you may recall, is being probed by the House Oversight & Government Reform committee for its recall of millions of bottles of pediatric over-the-counter meds due to quality-control issues, such as incorrect amounts of active ingredients and metallic fleks. Citing internal J&J documents, the committee says this was a 'phantom recall' designed to mask the extent of the problem, which the company did not want publicized overs fears that sales and its pristine image would be damaged. At issue, however, is the extent to which, if any, the FDA may have played in shaping the decision making at J&J's McNeil Consumer Heathcare unit.
J&J has denied any attempt to hoodwink the public. But the committee, which next week will grill J&J ceo Bill Weldon, persistently points to a May 27, 2009, email from a McNeil exec who wrote to a colleague that they "negotiated with the FDA not to conduct a (formal) recall" for one type of Motrin made at a Puerto Rico facility, but instead would pursue a "soft market withdrawal." The implication was that the FDA approved, in part, J&J's conduct, which involved hiring contractors to purchase meds from convenience stores. The FDA has denied this.
Earlier this week, Ed Towns, who chairs the committee, demanded J&J submit proof of such an agreement by 12 noon yesterday. Several hours later, the health care giant submitted a letter from Ethan Posner, a partner at Covington & Burling, in which he concedes no such agreement existed. "Let us first say that Johnson & Johnson and McNeil believe that although the purchase of the Motrin products at issue complied with legal requirements, moving forward the company would handle things differently," he writes.
Then he adds: "...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.' We have not sought to characterize to this committee McNeil’s interactions with the agency as constituting a formal agreement not to recall the Motrin caplets." And Posner goes on to say that, while "no one from McNeil, to our knowledge, has stated to the committee that there was a formal written agreement with the FDA," a string of emails and two field reports submitted to the FDA "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."
The emails (please look here) stitch together a conversation between Eddie Carrillo, the quality site leader at the Puerto Rico plant and two other McNeil managers, including Bob Miller, a quality compliance exec, and Paul DiPaulo, senior director for quality assurance, about his communication with Maridalia Torres, the district director of the FDA's San Juan office. Miller, by the way, is the McNeil exec who mentioned the 'soft market withdrawal' agreement with the FDA in his May 2009 email.
On March 12, 2009, Carrillo wrote that Torres was "empathetic," and that the discussion he had with Torres was "between her and myself, because nobody can state that she is in agreement to or/not to recall the (troubled) batch." He also also wrote that Torres was "willing to evaluate the data that reflect that there is no product in the market," and he informed Torres that he would issue a follow up field alert that would describe McNeil’s plan for a market assessment.
As Posner wrote: "As we understand it, McNeil was told that it could proceed with an assessment of how much affected product remained on the market before a final decision was made about a recall. The FDA representative made clear that she wanted evidence that the affected Motrin caplets were no longer on the market."
Then on April 20, 2009, DiPaulo writes an email stating: "Just received some good news from San Juan FDA District Director. She is in agreement with continuing to pull product from the rest of the stores and NOT consider this a national recall." He then refers to info in a Field Alert Report dated April 21, 2009, which indicates about 1 percent of two Motrin lots that didn't dissolve properly had been found. The report adds that McNeil bought all Motrin from the lots at convenience stores in the US.
Meanwhile, J&J apparently was calling its campaign a product retrieval, not a recall. As we reported previously, in a July 16, 2009, e-mail from Neisa Alonso, an FDA investigator and recall emergency and coordinator, she wrote to Carolyn Parziale, a director of quality assurance at McNeil. that “your company is doing a recall even though you are calling it a retrieval.” The FDA’s position, she continued, is that J&J should do a recall, because it already appears that one is under way. A recent Motrin sampling, she added, failed a dissolution test and such failures “typically” result in recalls.
The FDA has cited this communication as evidence that the agency did not approve of J&J's program. A spokeswoman for the committee had this to say: "J&J's response to the chairman's letter demonstrates there was no negotiated agreement."