If Good Manufacturing Practices are about anything, it's control: Control of equipment, processes, and the activities of those who put the two together to make drugs.
Donald Riker, founder of OnPoint Advisors, describes the Tylenol recalls of the past few months as "the systemic failure and partial collapse of overarching quality systems within J&J, in theory involving all plants and brands until otherwise proven." Quality systems are the drug manufacturing foundation. "There is no way now to judge the full extent of the system failure, which is internal to the company, self-inflicted, and always within its sphere of control," he writes in OTC Product News.
Jim Edwards agrees in BNet that J&J has suffered such a collapse and may well have lost control of its operating units. The behemoth cut corporate compliance staff by half and changed its mission from oversight/risk-reduction driver to compliance consultant. On Weldon's watch, it abolished a corporate program that gave operating unit presidents a compliance review every six months.
Hearings scheduled for tomorrow (Thursday, May 27) will encompass the ongoing FDA investigation of more than 700 reports of adverse events in patients using the recalled medications. Both the FDA and J&J have been asked to testify, though neither chief is expected to be present. The Congressional Committee on Oversight and Government Reform plans to provide a webinar of the hearings beginning at 10 a.m. Eastern time on Thursday.
J&J, of course, has apologized and promised to turn over a new leaf while McNeil vows to fix the manufacturing problems that led to the recent recalls, reports sister publication FiercePharma. The brand holder promises a comprehensive action plan by July 15.
In regulatory time, that's fast. In recall time, it's terribly slow. Let's hope that in today's hearings J&J and McNeil will be able to provide at least an outline of the steps taken to this point and some indication of those to come. It will be a lot easier to believe that midsummer plan if there's at least a glimmer that something is happening now.
- see the Riker column
- read Edwards's take
- here's the link to the Congressional webinar