Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, December 7, 2022
| Glenmark Pharmaceuticals Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Saffron USA LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded | |||
| Cryos International USA LLC | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||
| Zuland Distributor Corp | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||
| Manzela USA, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||
| Maliba African Market Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||
| Kari Gran Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||
| AG Hair Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
Tuesday, December 6, 2022
FDA issued a final guidance, Homeopathic Drug Products,
- Today, the FDA issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. The FDA has developed a risk-based approach under which the Agency intends to prioritize specific categories of homeopathic drug products that potentially pose a higher risk to public health, such as those intended for populations at greater risk for adverse reactions, including those with weakened immune systems, infants and children, the elderly, and pregnant women, as well as ophthalmic and injectable products, because the routes of administration for these products bypass some of the body’s natural defenses. The agency anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for enforcement and regulatory action. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality. Previously, the FDA warned the public about certain homeopathic products, including those containing a toxic substance and ones recalled due to contamination.
Saturday, December 3, 2022
Former Vice President and General Manager of New England Compounding Center Sentenced to Prison Thursday, December 1, 2022
BOSTON – A former co-owner of the now-defunct New England Compounding Center (NECC) was sentenced today in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA).
Gregory Conigliaro, 57, of Southborough, Mass. was sentenced by U.S. District Court Judge Richard G. Stearns to one year in prison and one year of supervised release. In December 2018, Conigliaro was convicted following a 41-day jury trial of one count of conspiracy to defraud the United States.
Conigliaro was the Vice President and General Manager of NECC and served as NECC’s primary point of contact with federal and state regulators. Conigliaro conspired with the former co-owner of NECC and head pharmacist, Barry Cadden, and others at NECC to misrepresent to the FDA and the Massachusetts Board of Registration in Pharmacy that NECC was operating as a pharmacy dispensing drugs only pursuant to patient-specific prescriptions, when, in reality, NECC was shipping drugs in bulk across the nation for over a decade, evading regulatory oversight through fraud and misrepresentation.
Though he was well aware that NECC was routinely shipping drugs to customers throughout the country without patient-specific prescriptions, from 2002 through 2012, Conigliaro (and his co-conspirators) always represented to the FDA and the Massachusetts Board of Registration in Pharmacy that NECC was only dispensing drugs pursuant to valid, patient-specific prescriptions—even going so far as to create fraudulent prescriptions and present them to regulators to conceal NECC’s true activities.
Through this deceit, Conigliaro and NECC were able to avoid the FDA’s oversight authority—and the FDA’s requirement that drug-manufacturers follow cGMPs—and operate in a slipshod, unsafe manner, ultimately leading to a tragic outbreak of fungal meningitis that killed more than one hundred individuals and injured many hundreds more.
“Mr. Conigliaro and his co-conspirators repeatedly made the choice to put their greed over patient safety,” said United States Attorney Rachael S. Rollins. “In turn, nearly 800 patients suffered terribly and over 100 died. Today's sentence sends a clear message to healthcare executives – if you lie to regulators, the outcomes can be deadly and we will hold you accountable.”
The criminal case in this matter arose from the nationwide outbreak of fungal meningitis that was traced back to contaminated vials of preservative-free methylprednisolone acetate (MPA) manufactured by NECC. In 2012, nearly 800 patients in 20 states were diagnosed with a fungal infection after receiving injections of MPA manufactured by NECC, and more than 100 patients died as a result. The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug.
In December 2014, following a two-year investigation, Conigliaro and 13 other owners, employees and associates of NECC were charged in a 131-count indictment. The indictment did not charge Conigliaro with having any role in the drug manufacturing operations of NECC.
On July 7, 2021, Cadden was resentenced, following the government’s successful appeal of his original sentence, to 174 months in prison and ordered to pay forfeiture of $1.4 million and restitution of $82 million. On July 21, 2021, Glenn Chin was resentenced, following the government’s successful appeal of his original sentence, to 126 months in prison and three years of supervised release. Chin was also ordered to pay forfeiture of approximately $473,584 and restitution in the amount of $82 million.
U.S. Attorney Rollins; FDA Commissioner Robert M. Califf, M.D.; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; Christopher Algieri, Special Agent in Charge of the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office; Patrick Hegarty, Special Agent in Charge of the Defense Criminal Investigative Service, Northeast Field Office; and Ketty Larco-Ward, Inspector in Charge of the U.S. Postal Inspection Service’s Boston Division, made the announcement today. Assistant U.S. Attorney Amanda P.M. Strachan, Chief of Rollins’ Criminal Division and Assistant U.S. Attorney Christopher R. Looney of Rollins’ Health Care Fraud Unit prosecuted the case.
Updated December 2, 2022
Compounding Pharmacies: "Novo Nordisk A/S, the maker of Ozempic, said it doesn’t supply ingredients to compounders and issued a warning earlier this year about compounded semaglutide. The Danish pharmaceutical giant holds the patent on semaglutide, making it difficult for others to precisely replicate the drug, and it is suing several companies for patent infringement. Some compounders are mixing the drug with supplements, according to providers prescribing them to patients. Already, several recalls have been reported to the FDA".
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