The accusations were detailed in an indictment late last month. The DoJ said pharmacy owner – Gerald Tighe – and chief pharmacist – Stephen Kalinoski – told customers Med Prep’s facility met standards for sterile drug production when in reality it “fell far short of basic industry standards of cleanliness.”
Loretta Lynch, United States Attorney for the Eastern District of New York, said: “Med Prep and its two most senior executives engaged in a disturbing pattern of dangerous practices in order to save money and line their pockets.
“This indictment should send a strong message to those who would seek to put their bottom line before the health and safety of the public – those we entrust with preparing the medications that save lives must clean up their acts or face prosecution.”
Compound interest
The US FDA has been casting a closer eye over manufacturing at compounding pharmacies for the past few years following a number of contamination and quality-related problems.
Oversight of such organisations has a complex history. In the 1990s, the FDA was given right to identify drugs for which compounding posed a threat to efficacy or safety. However, in 2001 the agency was stripped of these powers after the US Supreme Court ruled them unconstitutional.
After that ruling – which prompted the dissolution of the FDA's Pharmacy Compounding Advisory Committee – regulatory monitoring of compounders was sketchy at best with the FDA becoming involved in various legal battles with firms it tried to regulate.
But the situation changed dramatically in 2012 when an outbreak of fungal meningitis was linked to a compounding pharmacy. In 2013, the FDA was granted powers to inspect both pharmacies and facilities that register as outsourcing sites.
Consent decree
Med Prep had already attracted the FDA’s attention. In 2010 the agency told the compounder it was concerned about the sterility of repackaging operations at its facility in Tinton Falls, New Jersey.
The scrutiny increased in 2013 after Med Prep temporarily halted production when mould was found in magnesium sulphate products made at the facility. Months later, after further inspections, the agency sought a permanent injunction against the compounder.
The indictment, which could earn the Med Prep defendants prison terms, follows just a few months after the arrest of executives from New England Compounding Center (NECC), the compounder linked to the 2012 fungal meningitis outbreak.