Johnson & Johnson CEO William Weldon admitted last week that the company “should have handled things differently” in regard to its “phantom recall” of Motrin. The second hearing of The House Committee on Oversight and Government Reform focused on the “phantom recall,” in which outside contractors were hired to pose as customers and buy two lots of 8-caplet Motrin vials to remove them from store shelves. The company said the Motrin was determined to have a dissolution issue and did not meet specifications, and that that is why the company wanted to remove the medication from stores—not because of a safety issue with the drug.
J&J said it let FDA know in March 2009 that it was using the contractor’s services to assess how much product was still available in stores. In April 2009, FDA was informed that the contractors would remove products from stores, but as FDA Deputy Commissioner Joshua Sharfstein said in his testimony during the hearing, FDA was not told about the scale of the product removal or the way J&J was executing it. In July 2009, FDA told J&J to issue a formal recall, which it did in early August 2009. As Weldon said in his testimony, the project to remove the product from stores was already completed by July, and he did not believe the company was wrong to use the contractors. He said:
“I believe that McNeil acted with good intentions, and I do not view the use of a contractor to retrieve product, by itself, as inappropriate. The retrieval of product in this case was targeted and very comprehensive. But this episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective product when they arise, and I can assure the committee that we are taking stock of the lessons learned.”
The subject of granting FDA the power to initiate recalls was discussed during the hearing. In his testimony, Sharfstein said that the “phantom recall” highlights the need to rethink the current system of voluntary recalls. “In this case, if FDA had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred,” he said. Committee Chairman Edolphus “Ed” Towns reiterated his belief in legislation he introduced in July, H.R. 5740, that would allow FDA to do so. A poll conducted on PharmTech.com in June showed that 72% of readers think FDA should have this authority.
In his closing statement at the hearing, Chairman Towns expressed concerns about the closeness of the working relationship between J&J and FDA, saying, “…there is often a thin line between ‘working cooperatively’ and having a ‘cozy relationship.’ The documents we have seen in this case indicate this line may have been crossed—early and often.” He said that the committee would continue to investigate this matter and interview key witnesses.