Thursday, February 26, 2015

Press Release: 37-count indictment was unsealed in Brooklyn federal court charging Med Prep Consulting,Inc. (“Med Prep”), a Tinton Falls, New Jersey, medical drug re-packager and processer, together with its president and owner Gerald Tighe and pharmacist-in- charge Stephen Kalinoski, with wire fraud and violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) for introducing adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration (“FDA”) and Med Prep’s customers

February 19, 2015: Medical Drug Re-Packager and Company's Senior Executives Indicted on Fraud Charges and Criminal Violations of the Food, Drug and Cosmetic Act


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Food and Drug Administration 
Office of Criminal Investigations


             U.S. Department of Justice Press Release

For Immediate Release
February 19, 2015

United States Department of Justice

Eastern District of New York


Earlier today, a 37-count indictment was unsealed in Brooklyn federal court charging Med Prep Consulting,Inc. (Med Prep), a Tinton Falls, NeJersey, medical drug re-packageand processer, togethewith its president and owner Gerald Tighe and pharmacist-in- charge Stephen Kalinoski, with wire fraud and violations of the Federal Food, Drug and Cosmetic Act (“FDCA) for introducing adulterateand misbranded druginto interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration (FDA”) and Med Prep’s customers, who consisted of hospitals and other healthcare providersThe charges in the indictment are merely allegations, and the defendants are presumed innocent unless and until proven guilty.
The charges were announceby Loretta E. Lynch, United States Attorney for the Eastern District of NewYorkand Margaret A. Hamburg, M.D., Commissioner of the FDA.
According to the indictment, Med Prep processed numerous drugs, including oncology and dialysis drugs, pain medications, anesthesia drugs, and operating room drugs, in purportedly sterile conditionsIan effort to gain market share, Med Prep repeatedly misrepresented to its healthcare providecustomers that itadhered to, and in some areaexceeded, industry standards and laws applicable to sterile drug preparation.In fact, the defendants producedrugs in a facility that fell far short of basic industry standards ofcleanliness, creating a risk to the health of already ill patientsand lied to healthcare providers about theirfailures to comply with basic sterility practices.
As detailed in the indictment, MePreand its two most senior executiveengaged in a disturbingpattern of dangerous practices in order to save money and line their pockets,” said U.S. Attorney Lynch.Instead of working to extend and enhance human lives, the defendants illegally pursuecorporate profits while putting at risk the healtand safety of vulnerable patients suffering from disease. Thisindictment 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.” In announcing the indictment today, Ms. Lynch gratefullyacknowledged the assistance and cooperation of the FDAs Office of Criminal Investigations; the United States Department of Healtand HumaServices, Office of the Inspector General, Office ofInvestigations; the UniteStates Office of Personnel Management, Office of the Inspector General; theDepartment of Justice, Civil Division, Consumer Protection Brancand Commercial Litigation Branch;the FDA’s Office of the Chief Counsel; the Office of the Attorney General of New Jersey; and the NewJersey Board of Pharmacy.
The production of unsafe and contaminated drug products poses a serious threat to the health of theAmerican public and cannot be tolerated,” said FDA Commissioner HamburgWe continue to use all ourauthorities and to work with the Department of Justicand the states to ensure such practices are quicklyidentifieand stopped. Americans deserve nothing less.”
According to the indictment, Med Prep halted its production of drug products in the summer of 2013following an incident in which it had distributed intravenous drugcontaining visible mold to a Connecticut hospital. Soon after mold was discovered, the FDA inspected MePrep’s facility and documented numerous incidents of microbiologicacontamination in the companys finished drug products. Notably, the investigators found that the same species of mold present in drugs sent to the Connecticut hospital was also present in MePreps warehouse, where an unsterilizecart was regularly wheeled into a purportedly sterile“cleanroom” in which drugwere prepared by MePreemployeesFDA investigators also found that MedPrep shipped drug products to healthcare providers in some instances that were mislabeled with incorrect drug strengths and in other instances were labeled as the wrong drugaltogether.
Prior to 2013, the FDA haconducted severainspections of MePrepfacilities and repeatedly warned thedefendants thatheir practices and the conditions in their facility were unacceptable.  Tighe and Kalinoskiboth allegedly misrepresented to FDA investigators that Med Prep complied with industry standards designed to prevent harto patients that could result from non-sterility, yet they continued to handle steriledrugs in conditions far below anacceptable industry standards. As early as May 2007, Kalinoski learned that a MePreemployee responsible for repackinand processing drugs in MePrep“cleanroom” failed to treat an eczema skin condition for approximately five to six months while working in tharoom. Thedefendants never disclosed the employee’s skin condition to the FDA, nor did they take steps to prevent thedelivery to, or issue a recall from, healthcare providers of any of the drug products with which the employeehad come into contact.
If convicted, the individual defendants face maximum prison sentences of 20 years on each wire fraudcharge, five years on the charge oconspiracy to violate the FDCA, and three years on eaccharge of violations of the FDCA.
The government’s case is being prosecuted by Assistant U.S. Attorneys Justin D. Lerer, Ameet B. Kabrawalaand Erin E. Argo.
quoted from here

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