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Another FDA Warning and More Challenges for Johnson & Johnson

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When you are responsible for a blog, you try to be objective and even-handed.  You do not necessarily want to ‘pile-on’ not so flattering commentary regarding any one specific company. Thus, Supply Chain Matters has always had these perspectives in our published commentaries.  But alas, certain company seems to continue go out of the way in accumulating not so flattering headlines, and unfortunately, thus continues the saga of Johnson & Johnson these past months.

On May 22, J&J was the recipient of yet another warning letter from the U.S. Food and Drug Administration (FDA) related to plant inspection and unresolved findings concerning its Skillman, New Jersey facility.  The products cited involve multiple OTC offerings used by women and come under K-Y, Reach, Stayfree and OB branding names.

We learned about this development from a commentary penned by Dr. Ronald Riker on the OTC Product News web site. Dr. Riker has not held back on not so flattering comments related to J&J.  He notes the significance of this latest finding in that it comes in the shadows of the long-standing consent decree between J&J and the FDA. The finding involves a plant other than the previous McNeill OTC facilities located in Pennsylvania and Puerto Rico. What is also noted as different is that the products cited are not regulated as drugs, but as medical devices.

Supply Chain Matters also reviewed the subject FDA warning letter and noted similarities to previous findings related to certain breakdowns in J&J quality monitoring processes. Among various findings in the latest letter are:

  • Failure to establish and maintain adequate complaint files and procedures for receiving, reviewing, and evaluating product complaints.
  • Failure to promptly review, evaluate and adequately investigate complaints reported to the FDA
  • Failure to document results of design reviews
  • Failure to establish and maintain adequate procedures for implementing corrective and preventive actions to ensure that such action is effective and does not adversely affect the finished device.

The letter indicates a specific K-Y branded product has been misbranded and significant changes were made without submission of proper product submission documentation

In a further but separate development, today’s Wall Street Journal reports (paid subscription or free metered view) that J&J’s Ethicon business unit  is stopping sales of surgical insert versions of its branded Gynecare mesh products marketed to relieve pelvic discomfort in women. The WSJ notes that the decision comes after numerous reports of injury and several deaths, and that the J&J meshes are subject to hundreds of product-liability lawsuits according to a recent company securities filing. J&J has asked the FDA to allow the company to keep selling these products under abdomen surgical insertion procedures, and in the article, a J&J spokesperson is quoted as indicating that this is not a product recall but rather a discontinuation in light of changing market dynamics. J&J will be stopping sales over the next 3-6 months with the goal of completing the process by 2013.

Despite all the assurances of a new CEO and multiple executive re-alignments, J&J continues to exhibit findings and incidents of lax quality monitoring and regulatory process conformance. Evidence of a concentrated focus and cross-functional accountability for addressing clear evidence of systemic quality issues and troubled processes is not apparent from the lens of consumers and patients. As a result, the company’s previous stellar reputation for quality continues to erode at a rapid rate. This is not a condition that any healthcare or medical device products producer wants to be involved in, especially one ranked #22 in Gartner’s latest Top 25 Supply Chain ranking.

Bob Ferrari

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