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
Saturday, December 3, 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".
Thursday, December 1, 2022
Nov. 18, 2022
A doctor licensed in Virginia, Maryland, and elsewhere was sentenced today to 3 years for writing and referring compounded drug prescriptions in return for illegal kickback payments. The doctor previously entered into a civil settlement with the Government that requires him and the company he owned to pay $3.1 million.
Nov. 23, 2022
A licensed Orange County pharmacist has been found guilty by a jury of nearly two dozen federal criminal charges for her role in a health care fraud scheme in which more than 1,000 bogus prescriptions for compounded medications were filled, costing Tricare, the U.S. military's health care plan, more than $11 million in losses, the Justice Department announced today.
FOR IMMEDIATE RELEASE
Tuesday, November 29, 2022
Two Owners of New Jersey Pharmaceutical Marketing Company Admit Role in $38 Million Compounding Fraud Scheme
NEWARK, N.J. – Two owners of a New Jersey pharmaceutical marketing company admitted their roles in a $38 million compounded medication health care fraud scheme, U.S. Attorney Philip R. Sellinger announced.
Samantha Zaretzky, 42, of Wayne, New Jersey, and Lee Nichols, 43, of Fair Haven, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to separate informations charging each with one count of conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Through their company, Synergy Medical LLC, Zaretzky and Nichols exploited the manner in which health insurance plans processed, screened, and paid for customized drugs known as “compounded medications,” causing tens of millions of dollars of losses to several health insurance plans over two years. Zaretzky and Nichols pocketed millions of dollars through this compounding fraud scheme.
Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a medical professional determines that an FDA-approved medication does not meet the health needs of a particular patient.
From April 2014 to June 2016, Zaretzky and Nichols used Synergy as a platform through which they could market prescription-based compounded medications without regard to whether a health insurance beneficiary actually needed such a medication or whether an FDA-approved medication would have been appropriate and sufficient.
Zaretzky and Nichols and their conspirators determined which combination of compounded ingredients was most financially lucrative. Through their sales representatives, they recruited health insurance beneficiaries who were willing to obtain these expensive, but medically unnecessary, compounded medications before a medical professional had evaluated the beneficiaries’ unique and individualized need for the medications. After convincing the beneficiaries to obtain a pre-formulated compounded medication, in many cases, Zaretzky, Nichols, and their sales representatives steered beneficiaries to a medical professional with whom the beneficiaries had no prior doctor-patient relationship, such as a telemedicine company. Although the beneficiaries did not have a prior relationship with the telemedicine doctors, Zaretzky and Nichols paid that company for consulting with the beneficiaries. On at least one occasion, Zaretzky and Nichols paid an advanced practice nurse, whose license was inactive, to write prescriptions in exchange for cash. Once those medical professionals issued the prescriptions, Zaretzky and Nichols ensured that the prescriptions were steered to compounding pharmacies that paid them a kickback.
The health care fraud conspiracy charge carries a statutory maximum prison sentence of 10 years and a fine of $250,000 or twice the gross gain or loss from the scheme, whichever is greatest. Sentencing is scheduled for April 23, 2023.
U.S. Attorney Sellinger credited special agents and an analyst of the FBI, under the direction of Special Agent in Charge James E. Dennehy in Newark, and Defense Criminal Investigative Service, under the direction of Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s guilty pleas.
The government is represented by Assistant U.S. Attorney George L. Brandley of the Health Care Fraud Unit in Newark.
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
22-443
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Monday, November 21, 2022
FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD
November 21, 2022
Today, the U.S. Food and Drug Administration (FDA) posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).
Warning letters were sent to the following companies:
These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.
The use of CBD raises safety concerns, especially with long-term use. Risks include liver injury, harm to the male reproductive system, and side effects, such as changes in alertness and other symptoms. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.
FDA experts commented on the agency’s concerns with adding CBD to food and on information they want consumers to know. View the conversation on our website.
Today’s warning letters also outline additional violations of the FD&C Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.
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