This Drugmaker Can't Seem To Shake Its Manufacturing Problems
For Novartis (NVS) execs, the old cliche that ‘if it’s not one thing, it’s another,’ is becoming quite true. For the past year, the drugmaker has struggled to get a handle on manufacturing problems at several plants around the world, which have attracted scrutiny from regulators. The latest mishap occurred in Rosia, Italy, where a data-handling discrepancy caused some vaccines to be temporarily and voluntarily held for several months. The drugmaker undertook a so-called good manufacturing practice, or GMP, investigation and reported the findings to the European Medicines Agency and the Agenxia Italiana del Farmaco before shipments resumed two months ago, a Novartis spokesman confirms.
The disclosure comes after a facility in Nebraska suffered embarrassing gaffes involving over-the-counter meds and animal health drugs (see Pharma news and Pharma news). And the FDA sent a warning letter last November for “significant violations” at two other US plants – Broomfield, Colorado and Wilson, North Carolina. A Sandoz plant in Quebec, Canada, meanwhile, halted some production (see previous Pharma news and Pharma news) and there were problems at a facility in Austria (see Pharma news).
Novartis is not the only drugmaker to experience such widespread problems. Over the past two years, the FDA, entered into a consent decree with Johnson & Johnson (JNJ) (see Pharma news); closely scrutinized numerous Hospira facilities, prompting Wall Street to speculate that consent decree is on its way (see Pharma news); issued a warning letter to Merck KGgA about problems at three plants – one that makes active pharmaceutical ingredients, another that makes finished prescription drugs and a third that is responsible for testing meds for the US market (read Pharma news); and sent a stern and highly detailed letter to Sanofi (SNY) in which a raft of violations and deficiencies were cited at two plants that produce various vaccines (read Pharma news).
Whether Novartis is headed toward a consent decree is unclear. Despite the raft of serious problems other drugmakers have encountered, the FDA has not been quick to pursue such agreements, although the possibility, of course, always remains that the agency will consider such a step if manufacturing problems continue to appear systemic and intractable over a prolonged period. Meanwhile, Novartis execs are clearly on the defensive and, as part of the damage control, Novartis ceo Joe Jimenez used a memo late last week to announce a new internal initiative. The drugmaker has already made several managerial changes at its over-the-counter division and recently begged veterinarians to stick with its products.
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