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Once again J&J fails its female consumer, but this time not just Tylenol moms; KY women's products are subject of an FDA warning letter.  To find out why keep reading...

J&J has persistently failed its consumers through incompetence, bungling, and lack of focus in assuring that its over-the-counter products are safe and effective.  Although some of these same concerns and failures have cropped up at other branded OTC companies few, if any, have arisen in store brands.  J&J has indeed turned conventional wisdom on its head:  that consumers pay extra for brands because they are buying assurance of quality.  However, the facts support the opposite conclusion:  store brands are now as good or better and come at a lower price and better value.  Why pay up for incompetence and risk?

On May 22 J&J received yet another warning letter from FDA subsequent to a plant inspection and its failure to respond adequately to FDA's findings.  It reminds one of the traffic scofflaw who collects parking tickets when the penalty can be balanced against his net worth or cash flow.  This time the products cited were multiple OTC products used by women and regulated as simple medical devices.  These include:  KY Liquibeads, Warming Liquid, Jelly, Touch Massage, Sensual Silk; Reach Floss, Stayfree, Carefree and OB Tampons.  The warning letter spelled out multiple findings that J&J did not satifactorily address after the audit, including failure of its complaint handling systems, incomplete product investigations, invalid lot numbers on products, failure to validate products and conduct stability programs, failure of design review, failure of CAPA systems to investigate and prevent future failures, and failure to register or clear product before making changes in the product.  One case of toxic shock syndrome, a potentially life-threatening condition, was not reported within 30 days.  A widespread and damning series of failures that suggest systemic failure much as was first uncovered in its other plants several years ago.

The import of these new findings are important to understand.  First, the plant in question is not one of the plants under remediation in Puerto Rico, or Pennsylvania, but another in New Jersey.  Second, there is a long standing consent decree in effect.  Third, the products cited in the latest warning letter are not regulated as drugs but as medical devices.  Fourth, the inadequate responses to the FDA warning letter came in 2012.

J&J clearly has a deep interest in medical devices as judged by its recent corporate acquisitions.  However, what this FDA action reveals is that there is either not an overarching quality assurance umbrella at J&J which extends over all its medical device activities, or perhaps the obverse, if there is such an umbrella in place can these failures also occur in other medical devices brands outside the OTC business?  This is indeed a worrying "tell" that casts a longer shadow over ground where there should have been a clearing landscape by now.

Donald K. Riker, Ph.D.
Dr. Riker, President & Founder, On Point Advisors, LLC, is a former Associate Director, Personal Healthcare at Procter & Gamble, and Vice President of R&D/QA & Chief Scientific Officer at Chattem.

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