Under regulatory cloud, CEO says Novartis must boost quality

It has been a tough year for Novartis CEO Joseph Jimenez. In the course of 9 months, the company ($NVS) received a three-plant FDA warning letter, closed its key OTC plant and had to tell shareholders that revenues slid 4% because the manufacturing mess kept it from having its most popular consumer products. So, Jimenez says maybe it is time the company thinks differently about quality.

In a memo last week to employees and posted publicly by Forbes, Jimenez says the company is kicking off an initiative "designed to help change the way we think about quality and the way we demonstrate our commitment to it."

In it, he lists 5 behaviors that employees need to live by:

  • Think 'quality always'
  • Speak up for quality
  • Jointly own problems
  • Always ask 'why'
  • Build skills

In his update, Jimenez says that Excedrin is back in production at the Lincoln, NE, plant Novartis closed in December after FDA inspectors excoriated the company for the manufacturing mess there. So is the popular veterinary drug Sentinel. The CEO reiterated that "upon successful validation" Novartis will begin shipping a "limited portfolio of products from Lincoln in the fourth quarter."

Jimenez also said the Sandoz plants in Broomfield, CO, Wilson, NC, and Boucherville, Quebec--which were the subject of an FDA warning--are on track to complete remediation. The company has "new leadership in place, and we are investing in upgrading skills, modifying processes and modernizing equipment."

But for all of its efforts, Forbes points out that Novartis is still tripping over itself--and not just in North America. Recently, it had to undertake a GMP investigation for the European Medicines Agency and the Agenzia Italiana del Farmaco in Italy after a "data-handling discrepancy caused some vaccines to be temporarily and voluntarily held for several months."

Apparently, beseeching is the approach Novartis is taking these days. The company recently sent a letter to veterinarians pleading with them to remain loyal Novartis customers, even though its most popular vets' products are still not available, and it is unknown when Novartis will be able to deliver them.

- read the Forbes story

Special Report: Fierce's 2012 Top 10 FDA Red Flags

Related Articles:
Novartis' Q2 sales hit after Excedrin production woes 
Novartis remediation drags on longer than expected 
Closed plant leads Novartis to plead for vet loyalty 
FDA report shows deep problems at closed Novartis Consumer Health plant 
Novartis suspends production at another plant

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