The misdemeanor criminal charges are among the first levied against compounding pharmacies following a 2013 boost to FDA's regulatory authority over them.
The U.S. Food and Drug Administration, acting through the U.S. Department of Justice appears to have relied on the Park Doctrine to hold a corporate officer of a compounding pharmacy criminally responsible for the pharmacy's violations of the Federal Food, Drug, and Cosmetic Act (FDCA). As discussed in an earlier Duane Morris Alert, the Park Doctrine, also called the Responsible Corporate Officer Doctrine, allows the federal government to prosecute officers of an organization for the organization's violations of the FDCA, provided that those officers had sufficient authority to prevent the violation. Under the doctrine, such officers can be held personally liable even if they were unaware of the circumstances that led to the violations.
The Park Doctrine seems to have been at play in FDA's December 4, 2014, announcement that Main Street Pharmacy (Main Street) and its co-owner, David A. Newbaker, pleaded guilty in the United States District Court for the Western District of Tennessee to a criminal misdemeanor violation of the FDCA. In addition to Main Street's $25,000 fine, Newbaker received a separate $25,000 fine, as well as 12 months of probation. According to a press release from the U.S. Attorney's Office for the Western District of Tennessee, Newbaker "was responsible for, and actively directed" the pharmacy, with responsibilities including "oversight of employee training and the quality control of sterile drugs." It is unknown, however, whether Newbaker was directly involved in the circumstances that led to the FDCA violations.
The misdemeanor criminal charges are among the first levied against compounding pharmacies following a 2013 boost to FDA's regulatory authority over them. The increased oversight arose in the wake of a 2012 meningitis outbreak caused by contaminated products compounded by the New England Compounding Center. As discussed in the previous Duane Morris Alert, enforcement strategies similar to those used against Main Street Pharmacy were also used when Gary Osborn, the owner and head of compounding pharmacy ApothéCure, Inc., pleaded guilty to two misdemeanor criminal violations of the FDCA in late 2012.
Main Street's alleged FDCA violations arose when the Tennessee-based compounding pharmacy shipped contaminated doses of methylprednisolone acetate, leading to 26 adverse event reports from patients who had been injected with the contaminated product in four states. In May 2013, following these reports, Main Street recalled all of its drugs compounded for sterile use. Subsequent FDA inspections of Main Street found violations of Current Good Manufacturing Practice requirements, including microbial contamination of injectable drug products; improperly cleaned and disinfected equipment and rooms; an absence of written pest control plans; and insufficient laboratory testing procedures for identity, strength, quality and purity of compounded products.
In addition to the fines and probation sentence, a civil consent decree was issued, enjoining Main Street, Newbaker and co-owner Christy R. Newbaker from manufacturing, holding or distributing drugs until Main Street is compliant with the FDCA.
Given the renewed interest in the use of the Park Doctrine in prosecuting violations of the FDCA, compounding pharmacy executives should review their pharmacies? compliance procedures in order to ensure that their pharmacies are fully in line with FDCA requirements.