The U.S. District Court for Utah entered a permanent injunction against Isomeric Pharmacy Solutions LLC (Isomeric), William O. Richardson, its Chief Executive Officer (CEO), Rachael S. Cruz, its Chief Sales Officer, and Jeffery D. Brown, its Chief Operating Officer (COO). The consent order entered was an injunction prohibiting the defendants from distributing adulterated, misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.
A complaint was filed in July at the bequest of the U.S. Food and Drug Administration (FDA), alleging, the defendants failed to sufficiently remedy insanitary conditions that resulted in contamination.
Isomeric manufactures, labels, and distributes sterile drugs, including injectable hormones, injectable corticosteroids, and ophthalmic drops. The pharmacy/company is a direct to physician distributor. According to the complaint, there is a long history of the Defendants failing to maintain adequate sanitary conditions. According to Acting Assistant Attorney General Chad A. Readler “Compounding pharmacies must produce their drugs in a way that does not potentially endanger patient safety â€œThe Department of Justice will continue to work actively with FDA to ensure that compounding pharmacies comply with the law and provide safe products that doctors and patients can rely on.”
Isomeric was involved in four voluntary recalls in 2016 and 2017 after an FDA inspection. The 2016 recalls involved three types of injectable suspension drugs: triamcinolone diacetate 40 mg/mL, methylprednisolone acetate/lidocaine HCl 40/10 mg/mL, and betamethasone acetate/betamethasone sodium phosphate.
FDA Commissioner Scott Gottlieb, M.D. stated, “Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” “We will continue taking strong enforcement actions against compounders who violate the Drug Quality and Security Act and put patients at risk by failing to produce sterile drugs in compliance with the law.”
According to lawyer Jason T. Brown, who handles whistleblower actions, “This appears to all be government action and rightful responsive action. While the 9th Circuit has just opened the door for plaintiffs to potentially file certain claims that blow the whistle on things like fraud upon the FDA, this particular case would be challenging to bring as a qui tam, but the government alone did a commendable job.”