Novartis teams are working “around the clock” to resume production of the popular anti-parasitics Interceptor and Sentinel, as well as other animal health medications manufactured at the company’s Lincoln, Neb., plant.

That update comes via a March 16 letter to veterinarians. In it, Novartis officials acknowledge that the production shutdown in Lincoln — prompted by warnings from the U.S. Food and Drug Administration (FDA) — “has created a backorder situation … that has created significant challenges for practices and pet owners who rely on Novartis Animal Health products.”

The letter continued: “Given the large number of lines and products manufactured in Lincoln, however, the exact timelines remain uncertain. We hope to be able to give you a definitive date for a restart within the next few weeks.” 

Veterinarians have been dealing with Novartis backorders since Dec. 19, when the company ceased production of animal health products made at the Lincoln plant. In addition to Interceptor Flavor Tabs and Sentinel Flavor Tabs, several other veterinary-specific drugs including Clomicalm (clomipramine hydrochloride), Program tablets and suspension and Milbemite are manufactured at the Lincoln facility. 

Over-the-counter medications for humans, mostly pain relievers, also are manufactured there. 

Dr. Harold Beard, a practice owner near Little Rock, Ark., is among Novartis’ veterinary customers aggravated by perpetual backorders and what he considers a lack of correspondence from the company, apart from “vague” ‘Dear Doctor’ letters. 

“If they don’t get going pretty soon, I don’t see how we’ll go back to Novartis products,” he said in an interview with the VIN News Service. “I lack a little trust in what’s going on right now. 

“They’ve really not been very forthcoming and it’s been very frustrating,” he added. “I haven’t had any direct contact with the company.” 

The March 16 letter is one of at least three sent to veterinarians since December, when Novartis initially reported that its Lincoln plant was undergoing voluntary "process and compliance improvement activities.”

It soon became clear, however, that troubles at the Lincoln site were more significant, with the FDA playing a major role in the plant’s closure. Several scathing inspection reports released by the FDA revealed a slew of manufacturing mishaps, with warnings from the regulatory agency about quality control problems tied to plant operations.  

The FDA documented numerous repeat violations, indicating that consumers had complained about tablet mix-ups, foreign objects found in containers and the suspected tampering of bottles of Novartis’ human-health drugs manufactured at the Lincoln plant. According to regulators, Novartis failed to investigate consumer complaints and enforced poor quality-control standards that allowed some medicines produced there to become contaminated. 

In January, Novartis issued a consumer alert, warning that chipped or broken pills might be found in over-the-counter drugs such as Bufferin, Excedrin, Gas-X Prevention and NoDoz.  

Days later, Novartis also warned veterinarians of possible tablet mixups in bottles of the anti-anxiety medication Clomicalm (clomipramine hydrochloride), also manufactured at the Lincoln site. The company, characterizing the discovery of rogue tablets in Clomicalm bottles as a “rare possibility,” did not reveal exactly what might be mixed with the medication, if anything. 

Dr. Kenton Flaig, of Portville, N.Y., believes Novartis hurt its reputation by stressing that it closed its plant voluntarily. The production halt, he said, has had minimal impact on his hospital, which switched many of its patients to other medications.   

“Novartis calling their plant closing voluntary is like a man saying that he ‘volunteered’ to join the Army when his only other choice was to go to jail,” Flaig said. “Their plant was closed because the FDA caught them doing something bad.” 

So far, Novartis officials are tight-lipped about the series of events leading up to the FDA’s reports or exactly what must be done to ramp up compliance with regulators. 

The company's regulatory woes, however, extend beyond the Lincoln facility, into Canada.

In recent weeks, Canadian veterinarians have been grappling with the fact that a major generics manufacturer — Sandoz Canada Ltd. — discontinued some medications and downsized production of others in response to FDA citations noting product reliability concerns and safety issues tied to the Sandoz plant in Boucherville, Quebec. A fire that broke out March 4 in the plant's boiler room compounded the production challenges.

Sandoz is a division of Novartis. The company's products include cancer drugs, narcotic pain relievers, antibiotics and anesthetics.

According to a Canadian Veterinary Medical Association (CVMA) alert, the supplies of eight human-labeled medications from Sandoz that veterinarians frequently use are being impacted: midazolam, glycopyrrolate, fentanyl, hydromorphone, meperidine, morphine, diazepam and phenobarbital.

Although the FDA has no direct jurisdiction over a manufacturing plant outside the United States, foreign facilities that make drugs for the U.S. market are subject to agency inspections to ensure compliance with “current good manufacturing practices,” according to agency spokeswoman Karen Mahoney. In a November 2011 warning letter, the FDA revealed that investigators found “significant violations” of drug manufacturing rules at the Sandoz plant in Quebec, including a failure to implement written procedures designed to prevent microbiological contamination.

In light of the warning letter, Sandoz has “intensified its ongoing efforts” to improve quality control at the plant, said company spokeswoman Marija Mandic in an email to the VIN News Service. Asked when the production slowdown might end, Mandic responded that “a specific timeline cannot be given at this point of time, and will vary from product to product. Our objective is to restore normal levels of supply as soon as possible."

Sandoz stopped producing “some non-essential products, including ointments, ophthalmics, suppositories and certain injectable drugs, in order to focus local capacity on our core injectable portfolio," Mandic noted.

The shortage isn't expected to be fully resolved until the year's end, and the company's priority is to first supply human hospitals. To help veterinarians wait out supply shortages, the CVMA prepared a list of drug alternatives to be used as a guide.

Some members of the Veterinary Information Network (VIN), an online community for the profession, consider the situation to be untenable.

"How am I supposed to practice?" asked Dr. Susan Robertson of Yorkton, Saskatchewan, in a VIN message board discussion. "The head part of me is frustrated and angry. The heart part of me is breaking."

In terms of problems tied to Novartis' Lincoln, Neb., plant, company spokeswoman Julie Groce acknowledged the veterinary profession's frustrations.

“We understand that this is a serious inconvenience, and we deeply regret the significant challenges the situation has created for veterinary practices and pet owners who rely on our products,” she said by email. “As much as we would like to be able to provide a more specific (restart) date, there are still many production uncertainties to be managed."