Johnson & Johnson says FDA Knew About Motrin Buyback

Earlier this week we wrote about a so-called phantom recall allegedly orchestrated by pharmaceutical giant Johnson & Johnson (J&J) in which a contractor was hired to buy back potentially <"">defective Motrin tablets. The buyback was implemented, it seems, to avert a recall.

While no formal agreement was made with the US Food and Drug Administration (FDA), said Reuters, the agency knew that J&J’s McNeil unit implemented the buyback program, according to J&J lawyers. J&J and McNeil Consumer Healthcare, a J&J subsidiary, sent contractors nationwide to 5,000 convenience stores to buy the defective drugs without the public’s knowledge, said ABC News earlier this week.

We just wrote that the FDA claimed no knowledge of the plans, although McNeil claims it apprised the agency saying in a statement, “McNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner,” quoted ABC News previously. Meanwhile, the agency told ABC news, “When the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall, which the company agreed to initiate in July 2009.”

The a letter, obtained by Reuters yesterday, J&J attorneys said that McNeil kept “FDA apprised of its actions” even though there was no formal or written agreement over how to conduct the recall” and that it is “not aware of any indication” that the FDA was not in agreement with McNeil’s buyback plan, quoted Reuters. “We believe this record illustrates that McNeil acted with good intentions by keeping the FDA apprised of its actions and that there was no intent to conceal McNeil’s activities from the FDA,” the lawyers added. The letter was sent yesterday to the House Oversight and Government Reform Committee and precedes next week’s hearing over the broad recall of over 40 J&J products and a plant shutdown, noted Reuters.

In addition to an ongoing spate of recalls and in response to learning, in 2008, that some of its Motrin tablets were not appropriately dissolving, J&J worked to hide the problem, said ABC News. When drugs don’t dissolve properly, they might not work properly. And, in cases of manufacturing issues, products are generally recalled, regardless if imminent or apparent harm is presented, wrote ABC News prior.

The program involved a massive buy back of the defective Tylenol products, resulting in the purchase of 88,000 packages, said ABC News. At a May 2010 Congressional hearing, Colleen Goggins, J&J’s head of its consumer group, said J&J was not responsible for the buyback and was simply conducting an “audit” to determine where defective Motrin was being sold, said ABC News. “I don’t believe there was any intent to mislead or hide anything,” she said at the hearing, prior to resigning last week.

ABC News obtained emails that showed that some senior McNeil executives spearheaded the $400,000 Motrin purchase program stating, for example: “Do not communicate to store personnel any information about this product. Simply visit the store, locate the product and if any is found, purchase all of the product,” quoted ABC News. Another email shows Peter Luther, McNeil president writing, “Let’s make this happen asap.”

Chairman of the House Committee on Oversight and Government Reform, Representative Edolphus Towns (Democrat-New York), issued a formal inquiry to William Weldon, McNeil CEO, to look at the 2009 program, said ABC News.

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