It’s only a few weeks in to the New Year and it’s sad to say that 2012 is already shaping up to be as bad as 2011 was in regards to pharmaceutical product recalls.As I’m writing this we are learning more about the Novartis recall regarding a mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X made at Novartis’ manufacturing plant in Lincoln, Nebraska. People have also reported broken and chipped pills.
To me, immediately a few thoughts come to mind. They are all interrelated to a certain degree so let me jump right in.
First, with all of the high-profile recalls from last year, if you were a prudent company, would you not take a look at your operations, your staff and quality control systems just to make sure something like this would not happen to you? Especially in light of the huge financial costs and public relations nightmare you would potentially face?
Second, according to reports, the FDA cited this facility with numerous quality control problems – some dating back to 2009. According to the FDA, none of their problem reports were adequately reviewed. Why? Does the FDA not have the "teeth" to properly force a company to make quality improvements before everything comes crashing down and a product recall is required? Maybe it’s time the FDA was given a bit more "juice".
Finally, what is really happening inside these plants? I have visited several pharmaceutical facilities over the last year or so, of all sizes, and I have always come away impressed. The people in these facilities, at every level, have always been intelligent, committed and passionate about what they do and the patients they serve. I find it hard to believe that such dedicated people would allow such lapses in quality. Perhaps I’m naïve.
Am I right or wrong? Send me an email and let me know.