DEA alleges startup Truepill illegally dispensed Adderall, prescription stimulants
Wednesday, December 21, 2022
FDA approved Zycosan (pentosan polysulfate sodium injection) for the control of clinical signs associated with osteoarthritis in horses. Unapproved injectable formulations (including compounded formulations) of pentosan ....
- Today, the FDA approved Zycosan (pentosan polysulfate sodium injection) for the control of clinical signs associated with osteoarthritis in horses. Unapproved injectable formulations (including compounded formulations) of pentosan have a long history of use in horses, but Zycosan is the first injectable pentosan product to receive FDA’s approval. FDA-approved drugs, like Zycosan, have been demonstrated to be safe and effective for their intended use and have been consistently manufactured to preserve the drugs’ identity, strength, quality and purity. The FDA strongly encourages veterinarians to use Zycosan (pentosan polysulfate sodium injection) instead of unapproved drugs in their equine patients.
Monday, December 19, 2022
Department of Justice
U.S. Attorney’s Office
Middle District of Florida
FOR IMMEDIATE RELEASE
Wednesday, December 7, 2022
Former Sarasota Pain Doctor Sentenced In Health Care Fraud Kickback Conspiracy
Tampa, Florida – U.S. District Judge William H. Jung has sentenced Dr. Steven Chun (59, Sarasota) for conspiring to pay and receive kickbacks and bribes. Chun was sentenced to three years and six months in federal prison and ordered to forfeit $278,900, the proceeds of his offenses. On May 24, 2022, a federal jury found Chun and Daniel Tondre (52, Tampa) guilty of conspiring to pay and receive kickbacks and bribes, in the form of speaker fees, in return for prescribing the fentanyl spray, Subsys. Both were also convicted of five separate substantive counts of paying and receiving kickbacks. Tondre is scheduled for sentencing on December 15, 2022.
According to evidence presented during the 10-day trial, Chun was a doctor who owned and operated a pain management medical practice in Sarasota where he prescribed a large volume of Subsys, an expensive form of liquid fentanyl designed to be applied under the tongue (sublingual spray), allowing it to rapidly enter the bloodstream to help relieve break-through pain in certain cancer patients. Tondre was employed as a sales representative by Insys Therapeutics, Inc., the company that manufactured and sold Subsys. Insys, through its sales representative, Tondre, actively marketed Subsys to Chun by holding bogus and sham speaker events, and paid Chun $2,400 to $3,000 per speaker event in return for Chun writing more and higher dosages of Subsys prescriptions. The sham speaker programs were often only attended by Chun’s family and friends, or repeat attendees, and included many falsified or forged signatures of attendees. The sham speaker programs were designed to conceal and disguise kickbacks and bribes paid to Chun to induce him to prescribe Subsys.
According to the evidence, Insys paid Chun more than $278,900 in illegal kickbacks and bribes via the sham speaker programs over a period of less than three years. Tondre earned more than $737,000 in salary and sales commissions over a period of two and half years. Medicare Part D paid more than $4.5 million for Subsys prescriptions written by Chun.
During the sentencing hearing, two former patients of Chun testified regarding the devastating impact that Subsys had on their lives.
“This corrupt medical professional ignored patient care and instead inflicted financial pain,” said FBI Tampa Division Special Agent in Charge David Walker. “The FBI and its law enforcement partners work hard to ensure our nation’s federally funded healthcare system is protected from deception and greed.
“Contrary to proper patient care, the defendants repeatedly disregarded opportunities to promote legitimate, suitable pain management for beneficiaries to instead pursue personal gain,” said Special Agent in Charge Omar Pérez Aybar with the U.S. Department of Health and Human Services Office of Inspector General. “It is a top priority of our agency and law enforcement partners to bring to justice individuals who exploit their proximity to patients to defraud federal health care programs.”
“This sentence demonstrates the effectiveness of the Defense Criminal Investigative Service, our law enforcement partners, and the U.S. Attorney’s Office, in holding corrupt medical providers accountable when they fraudulently divert Defense Health Agency funds, putting their own greed before patient welfare,” said Special Agent in Charge Darrin Jones of the Defense Department's Inspector General, Defense Criminal Investigative Service, Southeast Field Office. “DCIS and our partners are committed to rooting out fraud and corruption and safeguarding the precious Taxpayer funding intended for the healthcare of our military members and their families.”
This case was investigated by the Federal Bureau of Investigation, the Department of Health and Human Services—Office of Inspector General, the Defense Criminal Investigative Service, and by the Opioid Fraud Abuse and Detection Unit at the United States Attorney’s Office, which focuses on opioid-related fraud and abuse by medical and health care professionals who have contributed to the prescription opioid epidemic. It is being prosecuted by Assistant United States Attorneys Kelley C. Howard-Allen and Jennifer L. Peresie.
Two Individuals Arrested For Pharmacy Health Care Fraud Kickback Schemes
Two New York women were arrested today on criminal charges related to their alleged participation in schemes to pay illegal kickbacks and bribes to Medicare beneficiaries and Medicaid recipients for medically unnecessary prescriptions filled by various pharmacies in New York that resulted in more than $10.5 million in total losses to Medicare and Medicaid.
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Monday, December 12, 2022
Atlantic County Man Sentenced to 37 Months in Prison for Health Care Fraud Conspiracy Targeting State Health Benefits Programs
CAMDEN, N.J. – An Atlantic County man was sentenced today to 37 months for his role in defrauding New Jersey state and local health benefits programs and other insurers by submitting fraudulent claims for medically unnecessary prescriptions, Attorney for the United State Vikas Khanna announced.
Brian Pugh, 45, of Absecon, New Jersey, previously pleaded guilty before U.S. District Judge Robert B. Kugler to a superseding information charging him with one count of conspiring to defraud a health care benefits program. Judge Kugler imposed the sentence today in Camden federal court.
According to documents in this matter and statements made in court:
Pugh was part of a criminal conspiracy in which state and local government employees were recruited and compensated to receive medically unnecessary compound prescription medications. Pugh and his conspirators defrauded New Jersey health benefits programs and other insurers of more than $50 million. Pugh directly caused the pharmacy benefits administrator to pay more than $1.4 million for medically unnecessary compound prescription medications for individuals he recruited into the scheme, and he received more than $430,000 in the conspiracy.
In addition to the prison term, Judge Kugler sentenced Pugh to three years of supervised release and ordered restitution of more than $1.4 million and forfeiture of $437,604.
Attorney for the United States Khanna credited special agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge James E. Dennehy in Newark; special agents of IRS - Criminal Investigation, under the direction of Acting Special Agent in Charge Tammy Tomlins in Newark; and the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Jonathan Mellone, with the investigation leading to today’s sentencing.
The government is represented by Assistant U.S. Attorneys Christina O. Hud, Acting Chief of the Health Care Fraud Unit; R. David Walk Jr., Chief of the Opioid Abuse Prevention & Enforcement Unit; and Desiree L. Grace, Deputy Chief of the Criminal Division.
Updated December 12, 2022
FDA, in cooperation with state departments of agriculture in CO, LA, NM, and TX, is investigating cases of illness and death in horses.
FDA Cautions Horse Owners Not to Feed Recalled Lots of Top of the Rockies Alfalfa Cubes due to Reports of Illness and Death
FDA, in cooperation with state departments of agriculture in CO, LA, NM, and TX, is investigating cases of illness and death in horses.
Fast Facts
- The U.S. Food and Drug Administration is cautioning horse owners not to feed Top of the Rockies alfalfa cubes with the date codes 111222, 111322, 111422, 111522, and 111622.
- These alfalfa cubes have been recalled by Manzanola Feeds of Manzanola, CO, which distributes products directly to feed stores and co-ops in 10 states. Further distribution is possible, so it’s important to check the date codes if you have these products.
- Top of the Rockies alfalfa cubes are sold in white and tan plastic 50-pound bags with green labeling. The date codes are on the front of the package.
- If you have Top of the Rockies alfalfa cubes with these date codes, or you can’t be sure of the date code of the products you have, throw them away in a secure container and follow the handling and cleaning instructions below.
- FDA is aware of at least 98 horses in Colorado, Louisiana, New Mexico, and Texas who showed neurologic symptoms. At least 45 of these horses have died or were euthanized due to declining health.
- The symptoms reported are consistent with botulism, and while further testing is underway to pinpoint the cause of the horse illnesses, horse owners and handlers should take precautions to protect human and animal health.
- Immediately consult a veterinarian if your horse ate this product and shows signs of neurologic illness, such as muscle tremors, difficulty eating or swallowing, difficulty standing, or collapse.
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| Centrient Pharmaceuticals India Private Limited | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| Cecilia Alvarez | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Gobwa Exotic Imports Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated Human Foods | ||||
| Euphoria Fancy Food Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
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