Tags

,

Novartis hopes to gradually restart production at its Lincoln, Nebraska manufacturing plant as early as May, and resume shipping some products at mid-year. But a return to full production will probably not happen until 2013.

Production will restart on a line-by-line basis, according to David Epstein, Division Head of Novartis Pharmaceuticals, who offered a status update during the Novartis 1st Quarter 2012 Earnings Conference Call earlier today (April 24th)

“[W]e are in the middle of quality remediation activities at Lincoln,” Epstein said, “and we are making good progress. We had a meeting with the FDA recently, and shared with them our startup plan for the plant. We will begin production in May and we will resume shipments mid year.”

Epstein indicated that the “ramp up” would be slower than expected. “We’ll have a relatively limited portfolio in the back half of the year. So we have signed up some third-party manufacturers for some key products,” he explained. Neither Epstein nor any other participant in the conference call specified the order in which Excedrin and other products manufactured at that plant would reappear. Nor was there any indication as to which products would be farmed out to third-party manufacturers.

Novartis suspended production at its Lincoln facility on January 8, 2012 and recalled more than 125 million bottles of Excedrin and other OTC medications after a FDA inspection revealed flagrant and long-standing deficiencies in the company’s quality assurance and consumer complaint procedures. The shutdown of the Lincoln plant also has affected availability of a number of veterinary products, including Interceptor, a popular medication for preventing heartworm in dogs and cats.

I asked FDA for a description of the steps usually undertaken in a situation such as this one. After making the usual disclaimer that “FDA does not comment on an ongoing investigation,” Shelly Burgess of FDA’s Office of Public Affairs offered the following explanation:

“FDA investigators conduct routine inspections at drug manufacturing facilities to determine, among other things, compliance with the current good manufacturing practice regulations. When the investigator finds significant deviations from those minimum standards, he or she lists the deviations on a document called a form FDA 483, or the “483,” and issues that to the manufacturer at the conclusion of the inspection. By providing this notice, the Agency gives a manufacturer the opportunity to take voluntary and prompt corrective action. The manufacturer may submit a written response to the Agency explaining how it has corrected the violations or plans to do so, or explain why it disagrees with any of the listed observations. In most cases, manufacturers comply voluntarily but in some instances FDA sends the manufacturer a warning letter or an untitled letter. In addition, where appropriate, FDA may pursue enforcement action such as seizure and injunction.”

“The timeline can vary considerably depending on the extent of the corrective actions that are required for the firm to achieve compliance and demonstrate sufficient controls over manufacturing to produce acceptable quality drugs. Some deficiencies can be corrected within hours or days of notification such as when re-training an employee or fixing a piece of equipment. Other corrective actions may take days or months, such as qualifying a complicated manufacturing operation or validating a new test method.”

It’s not surprising that the restart in Lincoln will be slower than Novartis had originally hoped, or that the company is being vague regarding which products will receive priority when production at the facility resumes. No one wants a repeat of the problems that led to the recalls and shutdown.

Nevertheless, the delay will result in additional headaches for consumers, pharmacists, doctors, and veterinarians as the product shortages continue.

Advertisements