What did they know and when did they know it? As it turns out, Johnson & Johnson's McNeil Consumer Healthcare unit learned of potency problems with Motrin in 2008, but instead of issuing a recall, the healthcare giant hired an outside contractor to buy Motrin from stores to determine whether a recall was needed. But the contractor's employees were instructed not to discuss a possible recall (look at this note by the contractor).
"We were informed that the company was considering what, if any medications needed to be recalled," FDA deputy commish Josh Sharfstein testifed before the House Committee on Oversight and Government Reform, adding that criminal penalties are being considered (see his opening remarks as well here). "...A state board of pharmacy contacted us that a J&J contractor was buying up all of the product (they could get) at stores with instructions to make this look like regular purchases. There was to be no mention" of a recall.
"This 'phantom recall' warrants further investigation by this committee," Edolphus Towns, the committee chair, asked in his opening remarks at today's hearing. "Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched?" As you know, J&J did not actually recall Motrin and other problem products until July 2009, when FDA inspectors asked about the contractor. The hearing is still under way. UPDATE: At 1 pm EST, J&J's head of its global consumer healthcare biz, Colleen Goggins, insists the FDA was aware of efforts to contractors to canvass and gather products, and that six key exec positions were changed, including OTC quality and OTC manufacturing. By July 15, J&J will have a 'master plan' to clean up its act.