By Karla L. Palmer –
On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act (FDCA). Under the terms of the plea deal, David Newbaker was sentenced to 12 months probation, and the pharmacy and Newbaker were ordered to pay a fine of $25,000. The Court also entered a civil Consent Decree of Permanent Injunction under 21 U.S.C. 332(a) against both Newbaker and the company’s co-owner, Christy Newbaker. The decree prohibits the co-owners and the pharmacy from “manufacturing, holding, and distributing drug products until the company comes into compliance with the FDCA” and its implementing regulations, among other requirements. Paragraph 29 of the Consent Decree sets forth additional penalties for any failure to comply with the Decree’s terms.
The Complaint stems from adverse event reports that FDA received in May 2013 resulting from injections of methylprednisolone acetate (“MPA”) compounded preparations dispensed by the pharmacy. In total, the Complaint alleged 26 adverse events relating to use of the pharmacy’s MPA. In response to the adverse events, FDA inspected the pharmacy in May and June of 2013, and analyzed samples of the product in which FDA allegedly confirmed the presence of microbiological contamination.
The case is interesting because it involves an incident and inspection that occurred on the heels of the 2012 New England Compounding Center incident and FDA’s April 2013 testimony to Congress that FDA’s authority to inspect pharmacies was hampered by “gaps and ambiguities” in the law, and that legislative action was needed. As has been well-documented (here and here), Congress passed the Drug Quality and Security Act (Public Law No. 113-54), which reinvigorated Section 5O3A and implemented Section 503B (creating outsourcing facilities, which are statutorily permitted to compound for office use but must comply with FDA’s current good manufacturing practices (cGMP)).
Although the Main Street Pharmacy Complaint for Permanent Injunction is based on conduct prior to Congress’ reaffirmation of FDCA 503A (21U SC § 353a), the government relied on violations of Section 503A (among other FDCA violations) in its Complaint. The government alleged that the pharmacy did not obtain patient-specific prescriptions for its compounded preparations, and thus the pharmacy was not entitled to Section 503A’s exemptions from the FDCA’s cGMP, new drug, and adequate directions for use provisions. The Complaint further alleged: (I) the conditions at the pharmacy established that all drugs “manufactured and distributed” were “adulterated” due to insanitary conditions (enumerated in the Complaint); (2) the drug preparations fell below United States Pharmacopeia quality and/or purity standards in violation of 2l U.S.C. § 35 1(b) (Strength, quality. or purity differing from official compendium); (3) the drugs were misbranded because they purported to be sterile but were not, in violation of 21 L.S.C. § 352(a) (False or misleading label); (4) the drugs contained inadequate directions for use and were not entitled to an exemption from this provision because the pharmacy did not comply with Section 503A (it lacked patient specific prescriptions for its compounded preparations); and, (5) the drugs were allegedly misbranded in violation of 21 U.S.C. § 352U) because of the noted microbiological contamination.
The Consent Decree entered by the Court permanently enjoins the co-owners and the pharmacy from directly or indirectly “manufacturing, holding or distributing” drugs unless and until they meet the strident terms of the Decree, including but not limited to retaining an independent expert to comprehensively inspect the premises and certify compliance with the terms set forth in the Decree. and an FDA re-inspection of the premises. The Decree sets forth comprehensive requirements for coming into compliance (Paragraph 14) so that the pharmacy may compound for individually identified patients under Section 503A. In addition, it also sets forth even more stringent requirements should the pharmacy ever choose to register as an outsourcing facility under Section 503B. Though the Main Street Pharmacy incident involves conduct that occurred prior the passage of the DQSA, it bears noting that we are still waiting on the outcome of the September 2014 federal grand jury indictment related to the NECC matter (which also occurred prior to passage of the DQSA). where the allegedly tainted medications caused far more significant injuries (including deaths) than the 26 adverse events reported in the Main Street Pharmacy case.