Here A Particle, There A Particle: FDA, Shortages And Troubled Manufacturers

How is this for bad timing? Yesterday, the FDA released a statement saying that there is a critical shortage of injectable drugs for total parenteral nutrition, a widely used intravenous solution for treating premature infants who are unable to eat or drink by mouth or experiencing other deficiencies. Why? A key supplier, American Regent, had temporarily shut down at the end of last year because of quality control problems, such as particulates found in injectable drugs. To compensate, the FDA is turning to imports from Fresenius Kabi USA, which will import the ingredients from Norway (see the FDA statement). Within the same hour, however, the FDA posted an alert that Fresenius Kabi USA began a voluntary recall of one lot of injectable magnesium sulfate due to ... drum roll… the presence of glass particles in the vials. Shipments were made a year ago, although no adverse events have been reported (look here). Of course, product recalls happen all the time for any number of reasons. Just ask Alex Gorsky, the ceo at Johnson & Johnson (JNJ). But the back-to-back announcements underscore the FDA had little choice and serve as a reminder of the numerous quality-control problems among many drugmakers. The agency, in fact, has been blamed by some members of Congress for overzealously enforcing manufacturing regulations, which have prompted some drug makers to halt production of certain drugs or scale back operations, all of which create more drug shortages (back story). There...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs