WASHINGTON, DC – Quality issues have plagued corporate giant Johnson & Johnson over the past year or so, including several recalls of over-the-counter medicines and the recent DePuy Hip Implant Recall. Both manufacturing problems and the strategies J&J has used to minimize publicity of these problems have prompted the House Committee on Oversight and Government Reform to investigate the company’s practices over the past few months. As part of this investigation, J&J CEO William Weldon is scheduled to testify before the committee tomorrow.
J&J’s recall of tainted Tylenol products for children and infants last year will likely be a focus of the committee’s questioning of Weldon. After learning in April 2009 that some of the raw materials used to make the Tylenol products had been tainted by bacteria, J&J subsidiary McNeil Consumer Healthcare continued to ship the medicines up to June 4th of that year, when the Food and Drug Administration cited McNeil for violations of good manufacturing practices (GMPs). According to J&J’s internal investigation, McNeil stopped using the tainted batch of raw materials and no bacterial contamination was found in the finished products or in the materials used.
The House Committee members are also likely to question Weldon about the fact that McNeil hired a private contractor to quietly purchase defective Motrin Products from stores in 2009 and 2009 in a so-called “soft market withdrawal” or “phantom recall.” McNeil claims to have formed a secret agreement with FDA regulators to complete the phantom recall by July 15, 2009 and thus avoid a full defective drug recall and the accompanying publicity. FDA spokeswoman Elaine Bobo strongly denied McNeil’s claim in a statement last week. The same committee heard testimony and evidence on this matter last week.