Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
By Dana A. Elfin
Jan. 6 — Under a motion filed Jan. 4 in federal court, drug compounder Downing Labs LLC will hire an independent outside expert to inspect its facility and make sure that facility complies with current good manufacturing practice standards.
The filing is a joint motion to enter and approve of a consent decree. The government also filed a complaint for injunctive relief against the Dallas-based company in the U.S. District Court for the Northern District of Texas Jan. 4.
The government sued Downing Labs LLC, its owners and its chief pharmacist over multiple ongoing violations at the facility, including the compounding of drug products under unsterile conditions.
Compounding is a practice in which pharmacists specially prepare medicines for individuals unable to take mass-produced medicines due to allergies, swallowing difficulties and other special sensitivities.
After a deadly 2012 nationwide fungal meningitis outbreak caused by contaminated, compounded drugs from Framingham, Mass.-based New England Compounding Center, the FDA stepped up its enforcement of compounding pharmacies. The NECC-related outbreak affected 751 individuals and resulted in 64 deaths in nine states.
The Food and Drug Administration previously cited Downing over sterility problems in connection with its compounded drug products.
The consent decree with Downing provides that the company won't be able to continue to compound drugs until an independent expert determines that the facility has implemented corrective actions required by the FDA to bring the facility into compliance with cGMP standards.
The decree, attached as an exhibit to the joint motion, was signed by Downing co-owners, Ashley Michelle Downing and Christopher Van Downing, and Roger E. Mansfield, Downing's pharmacist-in-charge, in December 2015. It is awaiting final sign-off from a federal judge.
“The consent decree is the latest step in Downing Labs’ transformation into a gold standard facility,” Downing Labs said in statement provided to Bloomberg BNA Jan. 5.
“Under the consent decree, Downing Labs has voluntarily agreed to a regular program of testing, audit, and inspection to ensure that it is achieving and exceeding its quality goals,” the company said.
The consent agreement will allow the company to resume the production of compounded sterile medications, it said. Because the FDA hasn't raised any concerns about Downing's production of non-sterile medications, the company will continue to produce those, Melissa Gilmore, one of Downing's lawyers, told Bloomberg BNA in a Jan. 5 e-mail.
According to the government's complaint, “Downing Labs and its immediate predecessor company, NuVision Pharmacy, Inc., have a long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality,” the complaint said.
Downing Labs purchased a compounder called NuVision Pharmacy Inc. in 2014. The FDA has warned Downing and NuVision over poor conditions and unsterile practices (12 PLIR 1297, 9/12/14), (11 PLIR 664, 5/24/13).
The FDA's most recent inspection of Downing Labs in the fall of 2015 revealed that Downing Labs was manufacturing drug products in violation of current good manufacturing practice (cGMP) requirements, the complaint said. The complaint cited “insanitary conditions” at the facility that may have contaminated the drug products manufactured there “with filth” or “rendered [the products] injurious to health.”
“There is no evidence to demonstrate that the defendants’ cleaning and sanitation are adequately performed to reduce the risk of microbial contamination to sterile drug products during manufacturing,” the complaint also said.
In addition to the FDA's actions regarding the Texas-based compounding facility, the State of Texas also has voiced concerns about compounding facilities in the state.
In August 2015, Texas's independent auditor for state government called upon the Texas Board of Pharmacy to fully implement and document its processes for inspecting the state's compounding pharmacies (13 PLIR 1219, 8/21/15).
The complaint against Downing was filed on behalf of the government by Mary M. (Marti) Cherry, Assistant U.S. Attorney, U.S. Attorney's Office, Fort Worth, Texas.
Michael E. Lackey and Kelly B. Kramer of Mayer Brown LLP in Washington and Melissa Gilmore with FDA Regulatory Counsel in Bethesda, Md., represent the defendants.
To contact the reporter on this story: Dana A. Elfin in Washington at email@example.com
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