After nearly three years of sparring with a recalcitrant compounder, the Food and Drug Administration has filed a lawsuit asking a federal court to prevent Downing Labs from continuing operations. And the compounder agreed to a consent decree, which requires the company to take various steps before operations can resume.
In the lawsuit, the agency cited numerous violations of so-called good manufacturing practices and several issued warnings to the company — which had previously been known as NuVision Pharmacy — about its failure to comply with regulations. Most recently, the Dallas-based compounder, which in 2014 refused to an FDA request to recall some products, failed yet another FDA inspection.
During that inspection, which occurred last fall, the FDA inspectors found unsanitary conditions, according to the lawsuit. And tests of both finished and unfinished products found traces of at least five different bacteria which, “if introduced into the body, can cause septic shock, pneumonia, and urinary tract infections,” the lawsuit stated.
The compounder has “a long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality,” the FDA wrote in its lawsuit, which was filed in federal court in Dallas earlier this week.
“Downing Labs continues to demonstrate that it is unwilling or unable to implement sustainable corrective actions to assure the sterility of its drug products and comply with [federal law]. The history of serious violations … and the likelihood that violations will continue in the absence of court action demonstrate that a permanent injunction is necessary,” the agency continued.
We asked an attorney for Downing to comment and will update you accordingly. [UPDATE: A spokeswoman for Downing sent us this statement: “Under the consent decree, Downing Labs has voluntarily agreed to a regular program of testing, audit, and inspection to ensure that it is achieving and exceeding its quality goals.”]
The move is the latest effort by the agency to crack down on wayward compounders in the wake of a 2012 outbreak of fungal meningitis that was traced to the New England Compounding Center. That episode led to 64 deaths around the country and was described by federal health officials as the worst public health crisis in the United States in decades. Compounding, you may recall, involves personalizing a medicine for a patient.
In response, the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. In fact, the FDA cited the defiant posture taken by Downing as an example of why a new law was needed to allow the agency to bolster its oversight and pursue legal options when compounders refused to upgrade operations.
The law, by the way, created two classes of compounders. One class — known as an outsourcing facility — can voluntarily register with the FDA, but then must follow good manufacturing practices. The idea is to give these compounders an incentive to appeal to their customers — which may include many hospital systems. In turn, these customers would, presumably, then have more confidence in the products.
Compounders that do not elect to take this step are still subject to FDA oversight, but the agency has struggled to get Downing to improve its operations. In June 2014, the FDA took the unusual step of issuing a public alert about Downing medicines and included a link to a 15-page inspection report showing numerous instances in which the company failed to investigate batches of medicines after finding sterility problems. The alert noted the products were marketed to the public as sterile.
Last June, Downing registered with the FDA, but as the lawsuit noted, the subsequent inspection that uncovered numerous ongoing problems prompted the agency to pursue an injunction.
This story was updated to note that a consent decree was entered into by the FDA and the company.