Sandoz Canada has suspended manufacturing at a sterile injectables plant and instituted what it calls a “proactive allocation system” for its injectable drugs, after a work interruption on Tuesday. More than 250 Teamsters went on a 24-hour strike over wage and benefits issues that they say tie back to stricter regulations imposed by the FDA and Canadian regulators.
Sandoz, the generics division of Swiss drugmaker Novartis ($NVS), says that the allocations will be based on “customers’ historical demand” and are intended to meet patients’ needs while also keeping all customers stocked. The company said Wednesday that it has decided not to resume production until an agreement is reached on a new collective agreement. "This is because any further impromptu work disruptions could pose unacceptable quality, security and compliance risks regarding the complex injectable medicines being produced at the facility," Annick Lambert, executive director of communications for Sandoz Canada, said in an email.
But the company said it did not expect the temporary suspension to have any impact on our customers, insisting its current inventory is sufficient to keep them supplied, Sandoz Canada said in a posting to its website. "We would also point out that more than 80% of Sandoz Canada injectable products are allocated at more than 100% of their current historical average."
The steps were taken after 267 Teamsters Canada workers at the Sandoz plant in Boucherville, Quebec, went on a 24-hour strike. A collective agreement expired on Dec. 31, 2015, and the union members voted in May to authorize a strike when deemed necessary. The workers were slated to return to the job when the strike ended at 7 a.m. Wednesday but a union official said Wednesday that Teamsters were turned away by security when they showed up to work.
The union and Sandoz are in negotiations over wages and pensions, but the union said in a statement that workers are “mainly unhappy about the many extra duties imposed on them due to increasingly complex and stringent standards issued by Canadian and U.S. regulators.” It said the added duties have led to worker sanctions imposed by Sandoz, and that has created a “climate of fear” at the facility. The Teamsters make up roughly 30% of the 900 employees at the plant.
As for Sandoz, Lambert said the company is “making every effort to reach a solution that is right for our employees, is sustainable for our business, and ensures that patients have continued access to important medicines.”
She said the company hopes to resume discussions shortly and expects that an agreement will be reached. “Over the past 30 years, we have built a strong industrial peace and it’s our objective to continue to do so,” she said.
The FDA began adding pressure to the plant back in 2012 after inspections at three Sandoz plants turned up issues, including what the FDA deemed repeat violations. The FDA took officials at Sandoz and Novartis to task in a warning letter for repeated crystallization problems in the sterile injectables manufacturing at the Boucherville facility, as well as plants in North Carolina and Colorado. The company responded with a remediation plan, suspending some manufacturing at the Quebec plant so fixes could be made. That, in turn, led to shortages of some drugs. The warning letter was closed out in 2014.