Novartis Tries More Exec Level OTC Switches

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.

6 Comments

Apr 25, 2012 - 6:58pm
Corporate Integrity Agreement (CIA) is still in effect...wonder if they are notifying OIG in a timely manner to changes in *compliance* managers as required by the CIA?

HR is divining whether interviewee *likes* Novartis. If not, adios.

Is love really blind or must it be blinded?

Apr 26, 2012 - 8:10am
Finally Cath Malseed was shown the door. The whole mess starts with her but doesn't end with he. Time to change the culture and not just through mega millions at the problem.
Apr 26, 2012 - 4:41pm
And if changing the execs doesn't "change" things, and "changing" the culture doesn't "change" things, what's Plan Q?

Something to think about the overall direction of "science-driven" cultures form an interview done in 1991:

WIESEL: Not even an animal, but an object. Because what they tried to do- you know, I believe, in general, they had a theory. They really wanted to create a universe parallel to our own. They wanted to reinvent creation. And in that universe, in that creation, a new language was invented, a new attitude towards human being, a new God. An S.S. man was God. We had no right to look at an S.S. man in the face, because you cannot look into God's face and remain alive. And therefore, in their concept of the universe, we were subhuman, unworthy of living. So what did they do? They shrank everything. Let's say, from the universe, we went to a country and a country to a town, from a town to a street, from a street to an apartment, apartment to a room, from the room to the cellar, from the cellar to the train. It's always smaller and smaller -- from the train to the gas chamber. And then the person, who was first a person, became a prisoner, and the prisoner became a number.

MOYERS: And the number became an ash.

May 16, 2012 - 4:41pm
Wow. Godwin's Law prove true really early in this one . . .

Seriously, I'm no fan of Novartis, but WTH was that last post about, and what connection does it have to Novartis inability to make pills that don't break?

May 20, 2012 - 11:01am
Anyone found an acceptable substitute for Novartis Slow FE Iron Supplement which is out of stock at all major retailers?
May 20, 2012 - 1:31pm
Here's a couple of choices:

http://www.windmillvitamins.com/Products/FE-Caps-TR-with-Stool-Softener-Caplets.htm

http://www.amazon.com/Ferro-Sequels-Potency-Supplement-caplets-100-Count/dp/B000087HF7