The United States filed a civil complaint and a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley Jr., to stop the manufacturing and distribution of adulterated drugs, the Department of Justice announced today.
The complaint, filed in the U.S. District Court for the Eastern District of Arkansas at the request of the U.S. Food and Drug Administration (FDA), alleges, among other things, that defendants distribute adulterated drugs in interstate commerce. According to the complaint, defendants’ drugs are adulterated because they are prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. The complaint also alleges that defendants’ drugs are adulterated because defendants fail to comply with current good manufacturing practice regulations.
“The Department of Justice is committed to ensuring that patients receiving compounded drugs are protected by the safeguards established in federal law,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work actively with FDA to ensure that the law’s protections are fully enforced.”
Cantrell initiated voluntary recalls of drug products in 2016 and 2017. The 2016 recall, initiated due to lack of sterility assurance, involved 29 lots of unexpired sterile drug products. The 2017 recall, also due to a lack of sterility assurance, encompassed all lots of unexpired sterile drug products that Cantrell had compounded and distributed between Feb. 16, 2017, and July 19, 2017.
FDA inspected Cantrell’s facility in 2013, 2016, and 2017, and the agency issued a Warning Letter to Cantrell in 2015. As alleged in the complaint, during the 2017 inspection, FDA documented evidence of insanitary conditions and significant deviations from current good manufacturing practice regulations. For example, as alleged in the complaint, FDA observed that the pharmacy’s own documentation 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. As alleged in the complaint, on at least 12 occasions between January and May 2017, defendants’ environmental monitoring in one of its clean-room areas detected microbes in excess of their “action limit” (i.e., a level of contamination high enough to trigger a response such as an investigation and corrective action). As noted in the complaint, the contamination consisted of bacteria, including Bacillus oleivorans, Staphylococcus epidermidis, Micrococcus luteus, and Bipolaris spicifera. The presence of any of those organisms in an injectable product administered to a patient could cause serious adverse effects to the patient.
In addition, as alleged in the complaint, FDA found deviations from current good manufacturing practice regulations in the pharmacy’s sterile drug manufacturing operations. For example, the complaint alleges that the pharmacy failed to conduct adequate investigations of microbial contamination found in aseptic processing areas (on surfaces, in the air, and on personnel), as well as spore-forming bacteria detected in areas of the pharmacy used for drug compounding and on operator gloves.
“The Food, Drug, and Cosmetic Act is designed to protect patients from potentially unsafe drugs,” said U.S. Attorney Cody Hiland for the Eastern District of Arkansas. “This action demonstrates our commitment to enforcing these laws. We remain steadfast in our dedication to keeping the citizens of our communities safe by whatever means available under federal law.”
If entered by the Court, the Proposed Order of Preliminary Injunction sought in conjunction with the filed complaint would require defendants temporarily to cease their current operations and to recall and destroy all non-expired drugs manufactured, held, and/or distributed by them. The Proposed Order also provides defendants with a pathway to resume manufacturing and distribution by establishing specific actions defendants must take to remedy their operations.
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Shannon Smith of the U.S. Attorney’s Office for the Eastern District of Arkansas, with the assistance of Associate Chief Counsel, Litigation, Jennifer Kang of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.