The U.S. Food and Drug Administration is taking Novartis (NYSE:NVS) CEO Joseph Jimenez to task with a warning letter that cites three of the company’s manufacturing facilities for “significant violations” at the company’s generics drug unit Sandoz.
The warning letter, sent to Jimenez on Nov. 18, outlines a long list of findings including insufficient written procedures to prevent microbiological contamination; inadequate procedures to assure that the drugs have the identity, strength, quality and purity they’re supposed to have; and a failure to find the cause of crystallization in an unnamed injectable product.
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Novartis, headquartered in Basel, Switzerland, has had at least three years notice for some of the problems. Many of the violations were first raised in a 2008 warning letter regarding the company’s Wilson, North Carolina plant. In the new warning letter, the FDA said that not only has an inspection turned up repeat violations at the Wilson plant, the same violations have also been found at another Sandoz plant in Broomfield, Colorado. Inspections of a third plant in Quebec, Canada found violations that were repeats of an earlier inspection at the site.
“It is apparent that Novartis International AG is not implementing global and sustainable corrective actions … Neither upper management at Novartis nor at Sandoz Inc., nor at Sandoz Canada Inc., ensured global, adequate or timely resolution of the issues at these sites,” the FDA said in the letter.
Jimenez acknowledged the warning letter in a message to Novartis employees obtained by Pharmalot.
“This is disappointing, but we are moving quickly to address broadly the issues in a sustainable way,” he wrote. “I will personally be involved in monitoring the progress of the remediation. I want to make it clear that neither costs, nor service level will interfere, as the remediation needs to take place as quickly as humanly possible.”
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The latest warning letter comes with particular urgency. The FDA will typically instruct companies to respond within 15 days of receiving the warning letter. But Pharmalot notes that the agency does not usually add that the Office of Manufacturing and Product Quality must be contacted within five days to schedule a meeting to discuss corrective actions.
Sandoz is not the only drugs manufacturer in North Carolina facing tough regulatory scrutiny. Hospira (NYSE:HSP) is in the midst of a multimillion-dollar remediation effort to bring its injectables manufacturing plant in Rocky Mount, North Carolina into compliance following a 2010 warning letter and subsequent inspection reports.
Sandoz is a significant player in the manufacturing of generic drugs. The unit’s $8.5 billion in 2010 revenue makes it the second largest generic drugs maker behind Teva Pharmaceuticals (NASDAQ:TEVA).
