Tuesday, March 23, 2021

PCCA responds to FDA Warning Letter - Pennsylvania Pharmacists Association

PCCA responds to FDA Warning Letter - Pennsylvania Pharmacists Association

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Wednesday, March 17, 2021

Pharmacist Charged in $4 Million Health Care Fraud and Kickback Scheme

A New York man was arrested today for his role in a conspiracy to commit health care fraud and to pay kickbacks and bribes to customers for expensive prescription orders in connection with more than $4 million in Medicare and Medicaid reimbursements.

According to an indictment returned by a federal grand jury in the Eastern District of New York, Robert John Sabet, 44, of Brooklyn, was the owner of Brooklyn Chemists in Gravesend, Brooklyn, and Lucky Care Pharmacy in Flushing, Queens. Since September 2016, Sabet allegedly conspired to bill Medicare and Medicaid for expensive prescription drugs that were not eligible for reimbursement because, among other reasons, they were not needed or not dispensed. Sabet also allegedly conspired to pay kickbacks and bribes to customers to convince them to fill prescriptions at his pharmacies, and to pay customers cash in exchange for the ability to bill Medicare and Medicaid for over-the-counter health care-related products on their behalf.  

In December 2020, Sabet allegedly wired nearly $100,000 from Lucky Care’s bank accounts to an automobile dealership to pay for a luxury car. Investigators conducted a search warrant at Sabet’s home at the time of his arrest and seized a 2020 Porsche Taycan worth over $250,000, as well as cash and luxury goods.

Sabet is charged with conspiracy to commit health care fraud, conspiracy to defraud the United States by paying kickbacks and bribes in connection with the provision of health care services, and unlawfully spending the proceeds of his fraud. The defendant is scheduled for his initial court appearance today before U.S. Magistrate Judge Ramon E. Reyes, Jr. of the U.S. District Court for the Eastern District of New York. If convicted, he faces a maximum penalty of 10 years in prison for conspiracy to commit health care fraud, five years in prison for conspiracy to pay kickbacks and bribes, and 10 years in prison for unlawful spending. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division; Acting U.S. Attorney Seth D. DuCharme of the Eastern District of New York; Special Agent in Charge Scott J. Lampert of the Health and Human Services Office of Inspector General (HHS-OIG), New York Regional Office; Special Agent in Charge Jonathan D. Larsen of IRS-Criminal Investigation (IRS-CI), New York; and Acting Medicaid Inspector General Frank T. Walsh Jr. of the New York State Office of the Medicaid Inspector General (OMIG) made the announcement.

HHS-OIG, IRS-CI, and OMIG are investigating the case.

Trial Attorney Miriam L. Glaser Dauermann of the Justice Department’s Fraud Section is prosecuting the case.

An indictment is merely an allegation and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Whistleblower came forward to report fraud and then was indicted Walter Simmons filed a whistleblower lawsuit, alleging that North Texas pharmacies and marketers paid kickbacks to doctors to prescribe unneeded pain cream to soldiers. Prosecutors say he was one of those doctors who were paid.

https://www.dallasnews.com/news/crime/2021/03/22/whistleblower-came-forward-to-report-fraud-and-then-was-indicted/?outputType=amp 

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  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to PYRLess Group, LLC dba Dr. Fitt for selling unapproved products with fraudulent COVID-19 claims. The FDA requested that the company take immediate action to cease the sale of any unapproved and misbranded products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care providers.

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations


The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”  

The FDA issued warning letters to:

The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.

The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these 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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