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Johnson & Johnson CEO Set to Answer Drug Recall Questions Tomorrow

Sep 29, 2010 | Parker Waichman LLP

Johnson & Johnson CEO Bill Weldon is expected to appear at a congressional hearing tomorrow to testify about a string of drug recalls that have tarnished his company’s once stellar reputation. It will be Weldon’s first major appearance on the recalls.

Other witnesses due to appear before the U.S. House of Representatives Oversight and Government Reform Committee on Thursday include FDA Deputy Commissioner Joshua Sharfstein and Colleen Goggins, the company’s longtime consumer healthcare chief who is due to leave March 1.

Johnson & Johnson has been under scrutiny since April 30, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of children’s Tylenol and other medicines because of concerns that they could contain higher concentration of active ingredient than the labels specified;. That recall came on the heels of another Children’s Tylenol recall that was issued in September 2009 over bacterial contamination. Over the past year, Johnson & Johnson has issued a total of six drug recalls that involved 200 million bottles of medicine.

McNeil has since shut the Fort Washington, PA facility that made some of the recalled drugs to address manufacturing problems cited by a Food & Drug Administration (FDA) inspection. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

Johnson & Johnson has also been criticized for what some have characterized as a “phantom recall” of Motrin tablets that occurred in 2009. At the time, the company hired a contractor to send out employees posing as buyers for an eight-caplet package sold at 4,000 convenience stores in 40 states. Contractors who participated in the program were told not to mention the term “recall.” Johnson & Johnson has asserted that the FDA new of and approved of its actions, but the agency disputes that. McNeil finally recalled 88,000 packages of the drug in July 2009.

Meanwhile, on the eve of tomorrow’s hearing, The Wall Street Journal is reporting that internal documents and emails raise questions about the Johnson & Johnson’s handling of the September 2009 Children’s Tylenol recall, which stemmed from the discovery of bacteria in raw material. At issue is how long it took Johnson & Johnson’s McNeil Consumer Healthcare unit to issue a public recall.

According to the Journal, an executive summary of Johnson & Johnson’s investigation into the matter indicates that McNeil officials learned on April 14, 2009 that Burkholderia cepacia bacteria tainted some raw materials that were to be used to make children’s and infant’s Tylenol. While those raw materials were not used in any medications, the company did make some Tylenol from raw materials that had been received earlier from the same batch. No bacteria were found in raw materials actually used in manufacturing, nor in the finished product, the company said

According to the Journal, an email between McNeil staff said the company kept shipping the medicines -more than 8 million bottles – until June 4, 2009, the same day FDA investigators cited the company for violating good manufacturing practices.

Other documents show that before finally recalling the medicines, the company hired a contractor to see how many bottles remained on store shelves and assess the kind of action it should take. On July 30, McNeil decided to recall the products and spent August finalizing the details of the recall with the FDA, the Journal said. Letters to retailers dated September 11 show McNeil began recalling the drugs from wholesalers on August 21, but the public wasn’t made aware until September 24.

Among other things, Weldon will be asked about the circumstances of that recall when he testifies tomorrow. In his invitation to Weldon, the committee’s chairman, New York Democrat Edolphus Towns, asked whether J&J had tried to avoid recalling Children’s Tylenol in 2009, the Journal said.

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