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FDA, Drug Compounder Trade Barbs in Shutdown Effort
The FDA’s bid to shut down an Arkansas drug compounder over allegations of “serious deficiencies” is drawing a heated response from the company owner, who says he’s fighting “a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts.”
The FDA alerted health care professionals and patients not to use products made by Cantrell Drug Company of Little Rock, including drugs intended for sterile injection. The agency said it is “concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk.”
FDA Commissioner Scott Gottlieb, MD, weighed in on the issue March 1, stating: “Despite the FDA’s concerns about egregious conditions observed at Cantrell’s facility, during several inspections, with the most recent in [June] 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.”
In a preliminary injunction filed March 1, the Department of Justice and the FDA asked the U.S. District Court in the Eastern District of Arkansas to order Cantrell to stop manufacturing, processing, packing, labeling, holding and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related regulations. The proposed order also will require Cantrell to recall all nonexpired drug products on the market; drugs that Cantrell has compounded include opioids (some of which are in shortage) and common antibiotics.
FDA inspectors have “observed insanitary conditions and violations of current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health,” the agency said. In response to the FDA’s recommendation, in July 2017, Cantrell recalled all drug products marketed as sterile and ceased sterile compounding. “However, against FDA advice, the company resumed production and distribution without demonstrating that it had adequately addressed the problems identified,” the agency said.
But Dr. James L. McCarley, Jr., Cantrell’s Founder and CEO, said the company has in turn filed for a temporary restraining order to prevent the FDA from shutting the company down. The motion was filed in the U.S. Bankruptcy Court Eastern District of Arkansas Little Rock Division, where Cantrell sought Chapter 11 bankruptcy reorganization on November 7, 2017.
“My back is really against the wall,” said Dr. McCarley, who argued that the FDA’s concerns relate to “quality deficiencies that are strictly regulatory in nature and not in response to any product problem or patient illness. … My honest desire is to do things right and fully comply with all the FDA’s regulations.”
Dr. McCarley said he has outsourced oversight of quality assurance and quality control (QA/QC) to an expert third-party consulting firm, hired a new QA/QC director, and had the facility and quality systems inspected and reinspected by several QA/QC consulting firms. “Those independent experts concluded that we were operating under a state of sufficient quality control for release of safe product,” he argued. “We have also implemented their suggestions for improvements.”
And yet, he said, the FDA “declined an invitation to reinspect our facility. They also declined to have a conference call with us to discuss our progress and what else they might need, leaving us guessing and trying to cover all bases.”
“They want to shut us down for a third time in spite of everything we’ve done, and this time it will be the end of the company. We are a family-owned business, and we simply don’t have the resources to continue to fight a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts. All this is at a snail’s pace that would choke any small business.”
Cantrell is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act passed by Congress in 2013. The company specializes in sterile product compounding of intravenous medications and drug shortage injections for hospitals, and to a lesser extent for surgery centers and physician groups.