Stung by the ongoing problems at its consumer health manufacturing plant in Nebraska, Novartis has made yet another series of managerial changes in its over-the-counter division. The drugmaker, which reported a quarterly earnings drop that was attributed in part to the problems, has also created a new team to coordinate quality control upgrades among all divisions that are undergoing "committed remediation efforts," according to a memo from Novartis ceo Joe Jimenez.
Among the shifts, Thorsten Hartig was appointed to run US manufacturing for the OTC unit. And Didier Colombeen was named head of global manufacturing and supply, which involves running all aspects of manufacturing operations and the supply chain. Colombeen succeeds Cath Malseed, who has left Novartis to "pursue other career opportunities," the memo states. Meanwhile, Rick Lloyd is now region head for the Americas for the OTC.
Another change: Ivan Moller, who last month was named head of GMP manufacturing and quality program management, is leading what Jiminez calls a group-level 'Program Management Function' to handle companywide remediation activities and form a single quality program. The FDA sent Novartis a warning letter last November for “significant violations” at two other US plants – Broomfield, Colorado and Wilson, North Carolina – and a Sandoz plant in Boucherville, Quebec, in Canada, which has since halted some production (see here and here). The moves are only the latest installment in a managerial overhaul that began after several jarring problems emerged in Lincoln, Nebraska, where Novartis makes various over-the-counter items - such as Excedrin, No-Doz and Bufferin - and animal health meds (look here). Production was suspended in January and some drugs were recalled because they may have contained broken or incorrect tablets from other medicines. There was also a failure to investigate numerous consumer complaints (read here and here).
Two months ago, Naomi Kelman resigned as head of the OTC unit just one year after joining the drugmaker (back story). Meanwhile, sales of consumer health meds have slumped 20 percent to $932 million, which includes animal health meds, which were also affected by the problems in Nebraska. Jimenez acknowledged that only "a limited portfolio" of products will ship in the second half of the year and, to compensate, third-party manufacturers were retained to bolster suppies of select meds.
The FDA, by the way, has also visited a Novartis plant in Suffern, New York, according to sources who say the drugmaker recently retained the Quantic Group to assist with quality control upgrades. This is the same consulting firm that helped Genzyme, the Sanofi unit, after a consent decree was signed with the agency. When we first learned of the activity two months ago, a Novartis spokesman described the assistance as “routine” and “not reflective of quality control issues nor should it be taken as an indication that a problem exists.”
Sorry, folks, we could not duplicate the memo for you to read, but do have it stored in a safe place.