The maker of ready-to-use IV bags and preloaded syringes has been repeatedly cited for safety concerns at its four manufacturing plants over the past dozen years.
A federal judge in Illinois has slapped a permanent injunction against PharMEDium Services LLC in the wake of the Lake Forest-based drug maker's repeated safety lapses at compounding pharmacies in four states.
"PharMEDium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable," Acting Food and Drug Administration Commissioner Ned Sharpless, MD, said in a media release.
"We will continue to take appropriate enforcement actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients," Sharpless said.
Under a consent decree that came with Wednesday's injunction, PharMEDium cannot make or distribute its drugs from its Memphis, Tennessee plant until the FDA approves a corrective action.
PharMEDium President Scott Aladeen and Warren Horton, the company's vice president for Quality and Research and Development, were named in the permanent injunction as the people responsible for compliance with the consent decree.
PharMEDium had already shuttered its Cleveland, Mississippi plant in the wake of publicity surrounding the safety lapses.
Under the injunction, the company's Sugar Land, Texas, and Dayton, New Jersey plants must also hire independent compliance inspectors, FDA said.
PharMEDium is a major national supplier of ready-to-use IV bags and prefilled syringes. The safety concerns raised by the FDA and the ensuing plant closures greatly disrupted the supply of critically needed drugs to the nation's hospitals.
In a complaint filed this week by the Department of Justice at the request of the FDA, federal officials accused PharMEDium of violating the Federal Food, Drug, and Cosmetic Act "by distributing adulterated, misbranded, and unapproved new drugs in interstate commerce."
The FDA said in its complaint that "PharMEDium's drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health and because PharMEDium failed to comply with current good manufacturing practices."
The allegedly adulterated drugs included oxytocin and morphine sulfate.
The FDA said that PharMEDium also "distributed unapproved new drugs and misbranded drugs because PharMEDium failed to comply with all of the requirements for drugs compounded in a registered outsourcing facility."
Since 2013, the FDA said it has inspected PharMEDium's compounding pharmacies and found numerous infraction that resulting in a 2018 warning letter. The company had been previously warned of similar concerns about unsanitary conditions in 2007, FDA said.
Gabe Weissman, a spokeman for PharMEDium, said in an emailed response to HealthLeaders that the injunction is the end result of discussions that the drugmaker held with federal regulators.
"Those discussions have concluded and the now filed Consent Decree, which permits commercial operations to continue at PharMEDium’s Dayton, New Jersey and Sugar Land, Texas compounding facilities and allows administrative operations to continue at the Lake Forest, Illinois headquarters, represents an important step forward in our journey to sustainable compliance," Weissman said. "We look forward to satisfying all aspects of the Consent Decree, including requirements pertaining to the Memphis facility."
"During a period of rapid regulatory changes for 503B Outsourcing Facilities, PharMEDium has spent the last several months implementing substantial improvements centered on demonstrating our commitment to patient safety and applicable current Good Manufacturing Practice (cGMP) requirements," Weissman said.
"PharMEDium is committed to the highest standards of safety and quality. We will always evaluate and invest in efforts to achieve full regulatory compliance and best meet the needs of our customers and patients they serve."
“PharMEDium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable.”
Acting Food and Drug Administration Commissioner Ned Sharpless MD
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
Photo credit: Jarretera / Shutterstock
Top executives at PharMEDium will be held accountable for complying with a consent decree reached with the FDA.
The FDA has inspected PharMEDium's compounding pharmacies for the past six years and found numerous infractions that resulted in a 2018 warning letter.
PharMEDium had been previously warned of similar concerns about unsanitary conditions in 2007.