For Novartis 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 this and this). 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 here and here) and there were problems at a facility in Austria (see this).
Novartis (NVS) 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) (look here); closely scrutinized numerous Hospira (HSP) facilities, prompting Wall Street to speculate that consent decree is on its way (see this); 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 this); and sent a stern and highly detailed letter to Sanofi in which a raft of violations and deficiencies were cited at two plants that produce various vaccines (read here).
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 (read here and here).
In a note late last week, he offered a progress report in which he repeatedly insisted that 'quality matters' and that things are starting to look up. "I’m writing to update you on our progress in maintaining our commitment to quality across Novartis, and to describe the steps we are taking to further increase awareness of this commitment. It’s important to understand that quality matters because the people we serve have high expectations of us."
"...we must have a strong reputation built on a deep commitment to quality. We are demonstrating this commitment through ongoing improvements to our quality operations across Novartis... We are making progress resolving problems in these locations. We have new leadership in place, and we are investing in upgrading skills, modifying processes and modernizing equipment. We announced publicly that Sandoz is on track to meet its remediation commitments."
And in Nebraska, production of two meds - the Excedrin over-the-counter painkiller and the Sentinel heartworm treatment for animals - have resumed, he continues. Once validation is completed, he adds, Novartis expects to begin shipping a limited portfolio of products from Lincoln in the fourth quarter. Of course, whether consumers and vets embrace the brands remains to be seen. Numerous alternatives are available and Novartis will have to work hard to recapture market share.
Meanwhile, Jimenez is rolling out a "new initiative" that, he writes, "is designed to help change the way we think about quality and the way we demonstrate our commitment to it. Specifically, we need to strengthen five key quality behaviors and make them an even more visible part of our culture: think ‘quality always;’ speak up for quality; jointly own problems; always ask why, and build skills."
"I want our customers and regulators to know that each person at Novartis takes personal responsibility for quality. I want them to know that you are vigilant about quality, renewing your commitment every day. When you see something that’s not right, tell your colleagues, your managers, or me. When we do that across Novartis, we’ll deliver the consistent quality that people expect," he concludes. Quality matters, and I know I can count on you to ensure it is a priority" (here is the August 30 memo).
Clearly, Jimenez wants to avoid the sort of withering regulatory oversight that could result in ongoing visits by regulators at all of its plants indefinitely. The FDA, for instance, has already signaled a willingness to take a holistic approach to manufacturing reviews and such scrutiny can, of course, become costly. Whether such pep talks will amount to any significant change remains to be seen, but he is clearly worried that the string of problems has invited the sort of scrutiny that can reverberate for a long time.