BURLINGTON, Vt. (AP) — A Vermont compounding pharmacy has agreed to stop producing adulterated and misbranded drugs, the U.S. Justice Department said Monday.
Edge Pharma of Colchester and its owners and operators signed a consent decree with the Justice Department on Friday that requires Edge Pharma Inc. of Colchester to take specific remedial measures to ensure its products are safe and demonstrate to the Food and Drug Administration that they will comply with federal law.
In a complaint filed last month, the United States alleged that U.S. Food and Drug Administration inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do," Donald Ashley the director of the FDA's Center for Drug Evaluation and Research Office of Compliance, said in a statement distributed by the Justice Department. “This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”
In a Monday statement, David Lazarus, one of the attorneys for Edge, said that on April 27, a few weeks before the planned re-opening of the company, Edge Pharma voluntarily agreed to the consent decree, but neither admitted nor denied any of the allegations made by the Justice Department or the FDA.
“The allegations in the complaint are unproven and not admitted, including the allegations about patient safety, which Edge Pharma denies,” the statement said. “Edge Pharma agreed to enter into the Consent Decree in the hopes of moving forward and being able to service its customers and the patients who need Edge Pharma products.”
To achieve that goal, the statement said Edge Pharma has been cooperative with the FDA and the Justice Department.
The May complaint says that between July 2020 and September 2021, Edge received several reports of adverse events such as a painful burning or lack of effectiveness of an injectable pain killer, but it did not complete a thorough investigation to determine whether product quality had been compromised and contributed to the adverse events.