The House Committee on Oversight and Government Reform brought Johnson & Johnson (J&J) and FDA to the table on May 27 to take a hard look at J&J’s recent recall and GMP compliance problems. In focus at the Congressional hearing were J&J’s actions – including what was referred to by the committee as a “phantom recall” – FDA inspection findings, and possible further GMP and criminal investigations.
Committee chair Edolphus Towns (D-NY) opened the hearing by noting the concerns and questions that have resulted from the recall by McNeil, a division of J&J, of 136 million bottles of over-the-counter children’s products due to customer complaints and manufacturing issues at their Fort Washington, Pennsylvania plant. One of these questions had to do with J&J recall procedures.
Towns pointed to “disturbing information” that the committee obtained from FDA regarding how J&J addressed problems with one of its Motrin products in 2008. Rather than issue a recall, the document which FDA provided the committee suggests, Towns said, that McNeil “sent contractors out to stores to buy the product back and told the stores, ‘not to mention’ a recall,” and only announced a recall of the affected product when confronted by FDA about this. “Is this a standard operating procedure for McNeil?” he questioned.
Regarding the manufacturing and quality issues, the chairman emphasized that the committee needs “to know whether this is an isolated issue or part of a widespread problem” at McNeil. He said that the committee will also investigate what J&J is doing to resolve the issues and whether FDA needs additional resources or authority to ensure the safety of children’s medicines.
FDA Deputy Principal Commissioner Joshua Sharfstein represented the agency at the hearing, accompanied by CDER Office of Compliance Director Deborah Autor and Associate Commissioner for Regulatory Affairs Michael Chappell.
Sharfstein informed the committee that FDA has had “growing concerns about the quality of the company’s manufacturing process” due to a number of unsatisfactory inspections, beginning prior to 2009 and extending through 2009 and 2010. He provided a chronology of events to illustrate what had occurred during that time frame.
More on Sharfstein’s comments and the give and take between FDA, J&J, and the Congressional committee is provided for subscribers on page 2. Links to key committee testimony documents are also provided. Note: The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.
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