The U.S. Department of Justice filed suit in federal court Thursday seeking to enjoin Cantrell Drug from manufacturing and distributing its injectable drugs that are principally used by hospitals.
The lawsuit came the same day the company asked a bankruptcy judge to prevent the department and the U.S. Food and Drug Administration from shutting down the 66-year-old company.
The company sought bankruptcy protection in November to allow it to re-organize after FDA inspections forced the company to temporarily suspend product manufacturing and shipping.
The Justice Department complaint said Cantrell Drug has been distributing what the FDA calls adulterated drugs across state lines. The FDA defines adulterated drugs as those that fail tests for generic pharmaceutical raw materials and finished products regarding quality, strength or purity.
The complaint, which also named the company's co-founder and chief executive officer, James McCarley Jr., also alleges that Cantrell's products "are adulterated because defendants fail to comply with current good manufacturing practice regulations," according to a Justice Department news release.
The agency noted Cantrell initiated voluntary recalls of drugs in 2016 and 2017, that the FDA inspected the company's facility in 2013, 2016 and 2017 and issued a warning letter to the company in 2015.
In the 2017 inspection, according to the complaint, the FDA "documented evidence of insanitary conditions and significant deviations from current good manufacturing practice regulations," the Justice Department said in the release.
The department cited as an example FDA observations of the company's own documents, which "revealed that Cantrell repeatedly recovered several types of microorganisms in the air and on surfaces used for sterile processing, demonstrating that products manufactured in those areas were prepared, packed, or held under insanitary conditions."
Further, according to the complaint, Cantrell's environmental monitoring in one of its clean-room areas detected microbes at levels that would warrant an investigation and corrective action at least a dozen times between January and May 2017.
The contamination consisted of four types of bacteria, including Micrococcus luteus, which is a common bacteria found on human skin but is associated with a variety of illnesses, including meningitis and catheter infections. When found in a sterile setting, it can point to the need for better clean-room management.
The complaint alleges violations under the federal Food, Drug and Cosmetic Act.
"The Food, Drug and Cosmetic Act is designed to protect patients from potentially unsafe drugs," said U.S. Attorney Cody Hiland. "This action demonstrates our commitment to enforcing these laws."
Cantrell Drug's troubles come as it and other compounding pharmacies have come under stricter FDA oversight after a deadly outbreak of fungal meningitis from compounded drugs provided by a Massachusetts pharmacy in 2012.
For his part, McCarley reiterated his claim in a statement issued Thursday that the FDA's concerns over the company's quality deficiencies are "strictly regulatory in nature and not in response to any product problem or patient illness."
McCarley said he has spent the past year and his life's savings "trying to satisfy" the FDA, including outsourcing oversight of quality assurance and quality control to an independent company and hiring a veteran director for quality assurance and quality control. He said the company's facilities have been repeatedly inspected by outside experts, which found the company to be "operating under a state of sufficient quality control for release of safe product."
The action by the Justice Department, if successful, "will be the end of the company," McCarley said in his statement. "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."
Cantrell Drug has a production facility in Little Rock and corporate offices in North Little Rock and was leasing the former Southwest Airlines reservation center at Bill and Hillary Clinton Airport/Adams Field. Airport officials said last month that they were told the company was giving up the lease.
The Justice Department's complaint was assigned to U.S. District Judge Kristine Baker. It was initially assigned to U.S. District Judge Billy Roy Wilson, who recused because he didn't have time to hold a hearing in the next few weeks. It then went to U.S. District Judge James Moody Jr., who recused for the same reason.
Information for this article was contributed by Linda Satter of the Arkansas Democrat-Gazette.
Business on 03/02/2018