The U.S. District Court for the Middle District of Florida entered a permanent injunction against Paul W. Franck, who has owned and operated numerous compounding pharmacies, to enjoin the distribution of certain sterile drugs products, the Department of Justice announced today.
“The American people must be protected from compounded sterile drugs that pose a risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division. “The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.”
The department filed a complaint in the District Court at the request of the Food and Drug Administration (FDA), alleging that Franck violated the federal Food, Drug and Cosmetic Act (FDCA) by causing drugs to become adulterated and misbranded while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
As alleged in the complaint, Franck has owned and operated numerous compounding pharmacies in the state of Florida over the past 20 years and he was responsible for providing final approval for all decisions concerning manufacturing and quality operations. The complaint alleged that the defendant and/or his employees manufactured, processed, packed, labeled, held and/or distributed drugs, including sterile drugs such as antibiotics, antivirals, cardiovascular drugs, drugs for pain management and total parental nutrition.
In conjunction with the filing of the complaint, Franck agreed to settle the case. The permanent injunction entered by the court requires that Franck cannot manufacture, hold or distribute any sterile drugs at or from his facility unless and until his facility, equipment, processes and procedures used to manufacture, hold, or distribute drugs are established, maintained, operated and administered in conformity with the permanent injunction and all applicable laws and regulations and are adequate to prevent such drugs from becoming adulterated or misbranded as defined in the order. Franck must also, among other things, establish and maintain a system to report to FDA all adverse drug experiences associated with his drugs.
The complaint alleged that a FDA inspection of Franck's Lab Inc., doing business as Trinity Care Solutions in May 2014, found conditions establishing that the drugs manufactured and distributed by the defendant were adulterated. For example, FDA observed dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the sterile manufacturing area, the area where non-sterile gowns were stored and donned, and the sink where employees prepared for sterile processing. In addition, as alleged in the complaint, FDA found other insanitary conditions, such as lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction; lack of positive air pressure in the clean room relative to surrounding rooms which compromises the cleanliness of the clean room's air; and materials around the laminar flow hood's vent that were not cleanable and were potential sources of viable and non-viable particles. The complaint alleged that the defendant violated the FDCA by causing articles of drug to become adulterated, in that they are prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health, while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
The complaint also alleged that FDA inspected the defendant's pharmacy, Franck's Lab Inc. dba Franck's Compounding Pharmacy, between March and May 2012. As alleged in the complaint, FDA initiated this inspection following reports of eye infections in patients who had been administered an injectable sterile eye solution, Brilliant Blue G (BBG) and/or injectable drug products containing triamcinolone (triamcinolone drugs) that had been compounded by Franck's Lab. As alleged in the complaint, FDA laboratory analysis of samples of the defendant's compounded BBG collected during this inspection revealed that the drug was contaminated with a fungus as well as other microorganisms, and these fungus-type organisms matched the clinical isolates from patients who developed eye infections after administration of this drug.
The complaint alleged, among other things, that the defendant violated the FDCA by causing drugs to become adulterated in that they consisted in whole or in part of a filthy, putrid, or decomposed substance, while such drugs were held for sale after shipment of one or more of their components in interstate commerce and that because the defendant's purportedly sterile drugs contained microbiological contamination, the defendant's labeling for such drugs was false or misleading. According to the complaint, as of March 2013, the U.S. Center for Disease Control had identified 47 cases of eye infections among 45 patients in nine states linked to exposure to the defendant's BBG and/or triamcinolone drugs.
In addition, as noted in the complaint, the defendant has conducted a number of recalls of drugs over the years manufactured and distributed from his pharmacies.
As part of the proposed consent decree submitted to the court, the defendant represented that as of the date of the entry of the decree, he is not engaged in the manufacture, holding, or distribution of any drugs, nor he is causing the manufacture, holding, or distribution of drugs. The permanent injunction provides that if the defendant intends to resume manufacturing, holding or distributing any drugs at or from his facility, he shall notify FDA in advance of doing so.
The permanent injunction includes limited, precise exceptions for drugs for animal use or any drug for which the defendant is the sponsor of a new drug application approved by FDA.
“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Director Janet Woodcock of the FDA's Center for Drug Evaluation and Research. “Today's action reflects the FDA's continued efforts to take appropriate and aggressive enforcement action against those who put patients' health at risk by choosing not to follow the law.”
The government is represented by Trial Attorney Roger Gural of the Civil Division's Consumer Protection Branch, with the assistance of Senior Counsel Michele Svonkin of the Department of Health and Human Services' Office of General Counsel – Food and Drug Division.
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