Pharmaceutical outsourcing company Cantrell Drug Company has filed for a temporary restraining order to prevent the US Food and Drugs Administration (FDA) from shutting it down.
The restraining order came on the same day as the US Department of Justice (DOJ), at the request of the FDA, filed a preliminary injunction seeking to prevent Cantrell from further manufacturing and distributing adulterated drugs.
Cantrell filed the restraining order to the United States Bankruptcy Court in the Eastern District of Arkansas to protect the interests of its creditors for at least 45 days during which it hopes to negotiate a resolution with the FDA while continuing normal business operations.
According to a statement made by the DOJ, the preliminary injunction was filed due to drugs manufactured by Cantrell being ‘prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health’.
The company manufactures sterile injectable pharmaceuticals that are primarily used in hospitals, including morphine sulphate injections that are currently on the FDA’s drug shortage list. The FDA has advised healthcare professionals and patients not to use compounded drugs from the company after concerns over serious deficiencies in Cantrell’s compounding operations.
In a statement, the FDA said: “Despite the FDA’s concerns about egregious conditions observed at Cantrell’s facility, during several inspections, with the most recent in 2017, the company continued to compound and distribute drugs without adequately addressing their potentially dangerous conditions. This reckless activity threatens patient safety and will not be tolerated.”
FDA investigators inspected Cantrell’s facility in 2013, 2016, and 2017 and issued a Warning Letter to the company in 2015. During the 2017 inspection, the FDA documented insanitary conditions and significant deviations from current good manufacturing practice regulations. The injunction offers Cantrell the option to resume manufacturing and distribution if specific actions are taken to improve their operations.
Cantrell voluntarily recalled drugs in 2016 and 2017 due to a lack of sterility assurance. However, according to the FDA, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified. The FDA is not yet aware of reports of illness associated with the use of Cantrell’s products.
Cantrell has disputed the FDA’s decision, arguing that the thousands of patients may not receive the pain medication they need if it shuts down.
“The FDA has inspected us twice in the last year and voiced concerns about quality deficiencies that are strictly regulatory in nature and not in response to any product problem or patient illness. I couldn’t be a stronger advocate for the safety of patients receiving our product. Over the years, we’ve manufactured millions of drug doses delivered to hundreds of hospitals and helped save thousands of patients’ lives “said founder and CEO of Cantrell Dr James McCarley.
“My honest desire is to do things right and fully comply with all the FDA’s regulations. I’ve dedicated the last twelve months and most of my life’s savings trying to satisfy the Agency.”
Cantrell previously filed for Chapter 11 Bankruptcy reorganisation, a form of bankruptcy that involves a reorganisation of a company’s business affairs, in November 2017. Cantrell attributed this to a temporary suspension of product manufacturing caused by FDA inspections.