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June 12, 2010 9:40 PM
June 11, 2010
During the course of the congressional hearing by the Committee on Oversight and Government Reform investigating the April 2010 recall of over-the-counter Johnson & Johnson/McNeil pediatric products, documents revealed that McNeil Consumer Healthcare, a unit of J&J, hired contractors to buy back defective Motrin products from store shelves secretly instead of issuing a recall.
McNeil first discovered a dissolution problem, the pill not dissolving at the intended rate, of its Motrin IB 200 over-the-counter pain reliever in November of 2008. The company halted its distribution of the product lot and sent a Field Alert Report (FAR) to the U.S. Food and Drug Administration (FDA) stating that a 3rd party contractor would perform a “statistical sampling” of retailers to determine if a recall was necessary.
The contractors hired by McNeil then allegedly embarked on a covert plan of “retrieval” to collect all defective Motrin from store shelves.
A document obtained by the Committee dated June 12, 2009 stated that WIS of San Diego, CA was recruited by Carolina Supply Chain Services (CSCS, now a division of Inmar) "on behalf of Johnson & Johnson" to purchase the affected Motrin. It outlined a plan called the CSCS Motrin Purchase Project in which contractors would visit stores as customers, locate and then purchase specific Motrin IB products.
“You should simply “act” like a regular customer while making these purchases,” the WIS document said. “THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!”
The FDA learned of the contractor activities and according to a Reuters article, FDA investigator Neisa Alonso wrote an email to McNeil on July 16, 2009 saying, “It seems that your company is doing a recall even though you are calling it a ‘retrieval’.”
McNeil finally issued a recall of the defective Motrin product in July 2009 after prompting by the FDA.
“Rather than doing the right thing and announcing a recall, we have learned that the drug company hired contractors to basically sneak into stores to purchase the products as if they were legitimate customers,” said Rep. Edolphus Towns, Chairman of the Committee on Oversight and Government Reform, in a June 3 press release. “We need to better understand Johnson & Johnson’s relationship with the contractor and get to the bottom of the services the contractor was asked to provide.”
On June 3, 2010, Chairman Towns sent letters to the contractors hired for the “phantom recall” of Motrin, Inmar, Inc. and WIS, requesting copies of all records relating to the Motrin work. The Committee also requested the identities of all J&J and McNeil employees and their agents involved, the number of suspect Motrin packages they purchased and what was done with them, and a detailed summary of any work either directly or indirectly the contractors provided in the past or are currently providing for J&J or McNeil.
“It wasn't until this caper was foiled by the Food and Drug Administration that McNeil did what it should have done in the first place and recalled the affected medication,” said Chairman Towns. “The company's motivation was apparently to save itself the embarrassment and potential financial loss associated with a recall.”
According to Reuters, Johnson & Johnson denied the “phantom recall” allegations on Friday.
"The FDA was kept informed of the survey and product retrieval and after it was essentially complete the FDA requested that we conduct an additional step, which was to conduct a formal recall, and we agreed," J&J spokesperson Bonnie Jacobs told Reuters.
Chairman Towns skewered Johnson & Johnson in his closing statement on May 27, 2010 after hearing of what he called, “Rolling recalls, a phantom recall, a plant shut down, and management firings.”
The hearing revealed that the J&J April 2010 recall of children’s medicines, which J&J reported as being 6 million bottles, was actually 20 times that amount at 136 million bottles. J&J stated no deaths had occurred resulting from the recalled medicines, but the FDA testified that the issue of whether these products caused deaths was an ongoing investigation.
“This is an issue of trust. When parents and grandparents give these medicines to their children, they want to be confident that they are not harmful,” Towns said in the statement. “Johnson & Johnson has the duty to ensure their safety and the FDA has the duty to enforce that duty”
Towns vowed to introduce legislation giving the FDA mandatory recall authority and the power to order a halt in drug production.