Tuesday, November 24, 2020
Department of Justice
Former Pharmacy and Marketing Company Sales Representative Admits Role in Compounded Prescription Drug Scheme
NEWARK, N.J. – A former pharmaceutical and marketing company sales representative today admitted his role in a conspiracy to defraud a New Jersey state health benefits program, U.S. Attorney Craig Carpenito announced.
Joshua Darstek, 38, of Freehold, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to a superseding information charging him with conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Compounding is a practice in which a pharmacist or physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The Food and Drug Administration does not approve compounded drugs and thus does not verify the safety, potency, effectiveness, or manufacturing quality of compounded drugs. Generally, a physician may prescribe compounded drugs when an FDA-approved drug does not meet the health needs of a particular patient.
Between May 2014 and January 2016, Darstek worked as a sales representative on behalf of two compounding pharmacies and a marketing company – referred to in the superseding information as the “Compounding Companies.” He marketed and sold compounded drugs to physicians, including pain, scar, and wound creams and certain supplements and vitamins. The Compounding Companies paid Darstek based on a percentage of the reimbursement payments they received from health care benefit programs for each prescription that he referred to the compounding pharmacies. Darstek participated in a conspiracy that recruited patients, many of whom had prescription drug coverage under the New Jersey School Employee’s Health Benefits Program, to submit medically unnecessary prescriptions for compounded drugs to the pharmacies. Darstek caused physicians to write prescriptions for individuals with whom they did not have any interaction for purposes of determining that a prescription for a compounded drug was medically necessary.
The conspiracy to commit health care fraud count carries a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense. As part of his plea agreement, Darstek must forfeit $148,500 in criminal proceeds and pay restitution of at least $594,639. Sentencing is scheduled for March 23.
U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark, and the Defense Criminal Investigative Service, under the direction of Acting Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s plea.
The government is represented by Assistant U.S. Attorney Bernard J. Cooney, Acting Chief of the Opioid Abuse Prevention & Enforcement Unit.
OIG to conduct risk assessment of CMS's oversight of pharmacies compounding drugs--expected completion date 2022
Medicare Part D Compounded Drugs
In 2016, OIG called attention to significant growth in spending for compounded drugs. Specifically, OIG found that Medicare Part D spending for compounded topical drugs grew by 625 percent during 2006—2015. OIG has been involved in an increasing number of fraud investigations related to compounded drugs. We will conduct a risk assessment of CMS's oversight of pharmacies compounding drugs for beneficiaries to determine whether systemic vulnerabilities affecting the integrity of Medicare Part D; specifically, we will assess the risk that pharmacies did not meet Federal and State requirements.
Medicare Part D Compounded Drugs
| 11/24/2020 | 10/16/2020 | Aurolife Pharma, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | ||
| 11/24/2020 | 11/16/2020 | Harmonic Nature S. de R.L. MI. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| 11/24/2020 | 11/19/2020 | Liq-E S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| 11/20/2020 | 11/18/2020 | Vibrant Health Care, Inc. | Center for Biologics Evaluation and Research (CBER) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 11/19/2020 | 11/18/2020 | Pro Breath MD, LLC dba Dentist Select and OraCare | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Wednesday, November 18, 2020
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by...
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Tuesday, November 17, 2020
Key facts in how compounding pain scheme evolved: Wade Walters testifies against doctor in MS compounded pain cream fraud case