District Court Enters Permanent Injunction Against Mississippi Compounding Pharmacy and Two of its Officers to Prevent Distribution of Adulterated Drugs
WASHINGTON – The U.S. District Court for the Northern District of Mississippi entered a consent decree of permanent injunction against defendants Delta Pharma, Inc. (Delta Pharma), its President, Dr. Tommy T. Simpson, and its Vice President and Pharmacist in Charge, Charles Michael Harrison, to prevent the distribution of adulterated drugs in violation of federal law, the Department of Justice announced today.
The entered permanent injunction stems from a complaint the Department filed in the U.S. District Court for the Northern District of Mississippi on June 4, 2018, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged, among other things, that the defendants distributed adulterated drugs in interstate commerce.
As part of the permanent injunction, defendants are enjoined from manufacturing, holding, or distributing any drugs manufactured from their facility unless they comply with specific remedial measures. Those measures include submitting a plan to FDA, which will provide for an independent expert to conduct inspection(s) of defendants’ facility and ensuring that defendants implement all recommended corrective actions. In addition, the defendants must report to FDA the actions they have taken to correct all insanitary conditions and deviations from current good manufacturing practice brought to their attention by the FDA or defendants’ expert. The permanent injunction provides that defendants cannot resume manufacturing, holding, and distributing such drugs until FDA notifies them in writing that they appear to be in compliance with the ordered remedial measures.
“Compounding pharmacies have a responsibility to ensure that they process and label drugs in a manner that ensures the safety and quality of such drugs,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to ensure that doctors and patients can rely on the drug safety protections in federal law.”
“The Food, Drug, and Cosmetic Act is designed to protect the American people,” said U.S. Attorney William C. Lamar for the Northern District of Mississippi. “This civil action demonstrates our commitment to enforce laws designed to protect the health and safety of the American public.”
According to the complaint filed by the Department, defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. The complaint also alleged that defendants’ drugs were adulterated because defendants failed to comply with current good manufacturing practice requirements.
FDA conducted an inspection of Delta Pharma in February 2017. According to the complaint, FDA investigators observed and documented numerous insanitary conditions, including the use of fifty-foot-long tubing to process purportedly sterile drugs, without determining whether the procedures for sterilizing the tubing are effective or assessing the tubing’s compatibility with the drug products to ensure that chemicals or particulates from the tubing do not leach, interact, or otherwise contaminate such drug products.
In addition, the complaint alleges that during the 2017 inspection, FDA documented numerous deviations from current good manufacturing practice requirements for drugs, including defendants’ failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. According to the complaint, the FDA also documented that defendants failed to thoroughly review and investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications; and failed to establish an adequate quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and has the authority to investigate any errors that may have occurred.
The consent decree of permanent injunction also resolved allegations in the complaint filed by the Department that the defendants distributed misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.
The government is represented by Trial Attorney Joshua D. Rothman of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney John Gough of the U.S. Attorney’s Office for the Northern District of Mississippi, with the assistance of Associate Chief Counsel Laura Akowuah of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Northern District of Mississippi, visit its website at https://www.justice.gov/usao-ndms.