For years now, Teva has had difficulty with the laser drilling of a schizophrenia drug so that patients get the right dose. The FDA, having finally tired of the company being unable to resolve the issues, has now slapped the plant in Florida with a warning letter.
The letter, posted Tuesday, acknowledges the company has already taken the agency’s advice to use an outside consultant, but faults it for repeat violations of problems pointed out during inspections of the Davie, Florida plant in 2013, 2016, 2017 and then again last year.
“These repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the FDA said.
A Teva spokeswoman in an email today said, “We are working closely with FDA to address its inspection-related concerns as quickly as possible.”
According to the warning letter, the problems at the Actavis plant in Davie predate, Teva’s $40.5 billion purchase of Allergan’s generics business in 2016. But the issues have continued for several years since, resulting in a recall of the paliperidone extended-release tablets in 2017, which started at the retail level but was then extended to the consumer level.
The company at the time acknowledged the dissolution issues tied to faulty laser drilling could reduce the drug’s effectiveness at treating a patient’s symptoms, “including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”
During a visit in August 2018, the FDA found issues with the visual inspection system and faulted the plant for not thoroughly investigating problems to find their cause, or of instituting fixes quickly enough. It raised questions about whether a single quality assurance inspector per shift would be able validate the “presence of a laser drilled hole that can be as small as 0.3mm" coming off the production line. The letter did not specify how many tablets that would be but when Actavis invested $40 million into the plant in 2013, it reported the facility produced about 2.2 billion immediate and extended-release units annually.
The buyout of Actavis in which Teva got the plant continues to be a drag on the Israel-based company. Last month Teva reported that 2019 would be more challenging than expected as generics eat away sales of its blockbuster multiple sclerosis drug Copaxone. The company forecast 2019 revenues between $17 billion and $17.4 billion, missing consensus forecasts of more than $18 billion. And it’s expecting non-GAAP earnings per share of $2.20 to $2.50 versus the consensus estimate of $2.77.