Thursday, October 17, 2024
Wednesday, October 16, 2024
| Far East Summit LLC | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
| Mexicanrxpharm.com | Center for Drug Evaluation and Research (CDER) | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
Tuesday, October 15, 2024
Friday, October 11, 2024
Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility. The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.
The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.
Tuesday, October 8, 2024
Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage
Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage
Friday, October 4, 2024
The state of Texas is accusing major PBMs and drug companies of colluding to raise the cost of insulin. Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs, as Noah Tong reports.
Thursday, October 3, 2024
Friday, September 27, 2024
- On Wednesday, the FDA’s Office of Criminal Investigations, as co-lead on an investigation with the Department of Health and Human Services Office of Inspector General, was involved in an indictment in the District of Puerto Rico charging 27 individuals with conspiracy to introduce misbranded drugs and to defraud the United States, as well as unlicensed wholesale distribution and various violations of the Drug Supply Chain Security Act (DSCSA). The defendants included unlicensed wholesale distributors and pharmacy owners and employees who, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the DSCSA, conspired to sell misbranded and diverted prescription drugs from unauthorized trading partners to pharmacy customers, without the customers’ knowledge that the products were misbranded and diverted. The scheme was identified, investigated and dismantled through the efforts of FDA-OCI, HHS OIG and the U.S. Attorney’s Office, District of Puerto Rico. The co-conspirators and others engaged in this scheme unlawfully generated revenue in an amount exceeding $13,000,000 by selling and distributing misbranded and diverted prescription drugs and billing insurance, costing Medicare and Medicaid over $7.6 million.
Wednesday, September 25, 2024
Pharmacists Convicted of $13M Medicare, Medicaid, and Private Insurer Fraud Scheme
A federal jury convicted four pharmacy owners yesterday for conspiracy to commit health care fraud and wire fraud.
According to court documents and evidence presented at trial, Raef Hamaed, of Maricopa County, Arizona; Kindy Ghussin, of Greene County, Ohio; Ali Abdelrazzaq, of Macomb County, Michigan; and Tarek Fakhuri, of Windsor, Ontario, Canada, all licensed pharmacists, billed Medicare, Medicaid, and Blue Cross Blue Shield of Michigan for prescription medications that they did not dispense at pharmacies they owned in Michigan and Ohio. The defendants collectively caused over $13 million of loss to Medicare, Medicaid, and Blue Cross Blue Shield of Michigan.
Hamaed, Ghussin, Abdelrazzaq, and Fakhuri were convicted of conspiracy to commit health care and wire fraud. Abdelrazzaq was also convicted of two counts of health care fraud and Fakhuri was convicted of one count of health care fraud. Sentencing hearings will be set at a later date.
Hamaed, Ghussin, Abdelrazzaq, and Fakhuri face a maximum penalty of 20 years in prison on the conspiracy count, and Abdelrazzaq and Fakhuri face a maximum penalty of 10 years in prison on each health care fraud count. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division; Special Agent in Charge Cheyvoryea Gibson of the FBI Detroit Field Office; and Special Agent in Charge Mario Pinto of the Department of Health and Human Services Office of Inspector General (HHS-OIG) made the announcement.
The FBI Detroit Field Office and HHS-OIG investigated the case.
Trial Attorneys Claire Sobczak, Kelly M. Warner, and S. Babu Kaza of the Criminal Division’s Fraud Section are prosecuting the case.
The Fraud Section leads the Criminal Division’s efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, currently comprised of nine strike forces operating in 27 federal districts, has charged more than 5,400 defendants who collectively have billed federal health care programs and private insurers more than $27 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit.
27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico
Press Release
27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico
SAN JUAN, Puerto Rico – On September 19, 2024, a federal grand jury in the District of Puerto Rico returned an indictment charging 25 individuals with conspiracy to introduce misbranded drugs and to defraud the United States. In separate indictment, another individual was charged with unlicensed wholesale distribution of prescription drugs. In a separate charging instrument, another individual was charged with and pleaded guilty to unlicensed wholesale distribution of prescription drugs.
According to court documents, from 2018 to the present, the defendants engaged in the unlicensed wholesale distribution of misbranded and diverted prescription drugs for financial gain. This unlicensed wholesale distribution included the sale of misbranded and diverted prescription drugs to local pharmacy employees and owners for subsequent sale to pharmacy customers, without the customers’ knowledge that the products were misbranded and diverted.
Diversion refers to processes by which prescription drugs are removed from, and then reintroduced into, the legitimate chain of distribution. Once a prescription drug is diverted outside of the regulated distribution channels, it becomes difficult, if not impossible, for regulators such as the U.S. Food and Drug Administration (FDA), law enforcement, or end-users to know whether the prescription drug package actually contains the correct drug or the correct dose. A drug is misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA) if its labeling: (1) lacked “adequate directions for use;” or (2) failed to bear “adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner or form as are necessary for the protection of users.” 21 U.S.C. § 352(f). Additionally, a drug is misbranded if it was a prescription drug and was dispensed without a lawful written or oral order of a licensed practitioner. 21 U.S.C. § 353(b).
The defendants purchased and sold prescription drugs in resealable plastic bags without any labels, markings, lot numbers, expiration dates or adequate directions as required by law, creating a significant risk of harm. These prescription drugs were often stored in personal residences and/or transported via United States mail. The co-conspirators and others engaged in this scheme unlawfully generated revenue in an amount exceeding $13,000,000 by selling and distributing misbranded and diverted prescription drugs.
In addition to the unlicensed wholesale distribution of prescription drugs, eleven pharmacy owners and employees from five separate pharmacies were also charged with a health care fraud conspiracy. These defendants caused materially false and fraudulent claims to be submitted to healthcare benefit plans representing that the products sold to customers were authentic and obtained through licensed pharmaceutical distribution channels. By selling diverted prescription drugs and billing healthcare benefit plans for authentic drugs, these defendants financially enriched the pharmacy owners and defrauded both the healthcare benefit plans and the pharmacies’ unsuspecting retail customers.
The defendants and their roles in the conspiracy were:
A. Pharmacy Owners and Employees- Pharmacy owners or employees who purchased drugs from unlicensed wholesale distributors and were involved in the buying and selling of misbranded and diverted prescription drugs:
[1] Valerie M. Cintrón-Rivera: co-owner of Farmacia Monte Verde in Bayamón, PR
[2] María T. Rivera-Fuentes: co-owner of Farmacia Monte Verde in Bayamón, PR
[3] Jaime Figueroa-Ramos: owner of Farmacia Santa Olaya in Bayamón, PR
[4] Elisa Cruzado-Ramos: pharmacist of Farmacia Santa Olaya in Bayamón, PR
[5] Nivia Ríos-Matos: pharmacy technician of Farmacia Santa Olaya in Bayamón, PR
[6] Raul Morera-Llera: co-owner of Farmacia Unity in Aibonito, PR
[7] Enid M. Rivera-Rosario: co-owner of Farmacia Unity in Aibonito, PR
[8] Gerardo A. Romero-Marcano: co-owner of Farmacia San Antonio in Canóvanas, PR
[9] Sheila Rodríguez-Agosto: co-owner of Farmacia San Antonio in Canóvanas, PR
[10] Gabriel A. Rodríguez-Malavé: co-owner of Farmacia Brisas del Mar in Luquillo, PR
[11] Rosaida Torres: co-owner of Farmacia Brisas del Mar in Luquillo, PR
B. Unlicensed Wholesale Distributors- Individuals involved in the unlicensed wholesale distribution and selling of misbranded and diverted prescription drugs:
[12] Alberto Meléndez-Nieves, a.k.a. “Bertin”
[13] Ángel L. Santiago-Cruz, a.k.a. “Aguacate”
[14] Eddin Orlando Santiago-Cordero, a.k.a. “Guayacán”
[15] Eric J. Collazo-Rivera, a.k.a. “Eric Manía”
[16] Javier E. Ortiz-Rivera, a.k.a. “Tato”
[17] Holvin E. Avilés-Carmona, a.k.a. “Holvin”
[18] Marlon E. Marino-Leal, a.k.a. “Chamo”
[19] José M. Amalbert-Rohena, a.k.a. “Chema”
[20] Miguel A. Rojas-Reyes, a.k.a. “Dr. Hacienda”
[21] Rosa M. Méndez-González, a.k.a. “Puruca”
[22] Antonio F. Portilla-Arzola, a.k.a. “Portilla”
[23] Reynaldo Guzmán-Martínez, a.k.a. “Bebo Canales”
[24] Moisés O. Heredia-Tineo, a.k.a. “Billy”
[25] José A. González-Maldonado, a.k.a. “Potala”
According to the investigation, the FDA approved prescription drugs that the defendants illegally distributed were:
Advair, Albuterol, Alphagan, Anoro Ellipta, Arnuity Ellipta, Aspen Dexamfetamine, Atripla, Atrovent, Azopt, Bepreve, Biktarvy, Breo Ellipta, Brilinta, Budesonide, Bumetanide, Byrdureon Pen, Cialis, Chloramphenicol, Collagenase Santyl, Combigan, Combivent Respimat, Daliresp, Delstrigo, Descovy, Dovato, Edurant, Eliquis, Enbrel, Entresto, Famotidine, Farxiga, Flavfour HFA, Flovent, Fluticasone, Fluticatone, Genvoya, Glyxambi, Humalog, Humira, Humulin, Hydroxyzine Hydrochloride, Incruse Ellipta, Invokamet, Invokana, Isentress, Janumet, Januvia, Jardiance, Jentadueto, Juluca, Ketorolac, Kombliglyze, Lantus, Latuda, Levalbuterol, Linzess, Lumigan, Malarone, Methimazole, Modafinil, Mounjaro, Naltrexone, Nebivolol, Neurin, Novolog, Odefsey, Onglyza, Ozempic, Pifeltro, Premarin, Prezista, Pro Air, Qvar, Restasis, Rinvoq, Rocklatan, Rosuvastatine, Rukobia, Rybelsus, Segluromet, Selegline, Silver, Soliqua, Spiriva, Steglatro, Stiolto Respimat, Stribild, Symbicort, Symtuza, Synjardy, Synthroid, Tivicay, Toujeo Pen, Tradjenta, Trelegy Ellipta, Tresiba, Trijardy, Triumeq, Trulicity, Ventolin, Victoza, Wixela, Xarelto, Xigduo, Zeal, among others.
In a separate indictment, Jorge Rivera-Pérez, a.k.a. “Jorge Pastilla”, was charged in a six-count indictment with unlicensed wholesale distribution of prescription drugs, misbranding of prescription drugs with intent to mislead and defraud, and theft, trafficking, and sale of pre-retail medical products. Defendant Jorge Rivera-Pérez was a purchasing and procurement department employee for Company A, a medical facility located in Manatí, Puerto Rico, and an entity that purchased prescription drugs from legitimate licensed wholesale distributors of prescription drugs kept as a pre-retail medical product to be used in the operations of the medical facility. Rivera-Pérez was not a licensed wholesale distributor for prescription drugs. The defendant used his position to obtain pre-retail medical products unlawfully and intentionally, to wit, prescribed medications, from the Company A storage warehouse access-controlled area located at the basement of the building and to subsequently sell them to individual pharmacy owners at a steep price discount when compared to legitimate wholesalers.
On September 23, 2024, Eric Aquino-García was charged via information and pleaded guilty before United States District Judge Gina M. Méndez to misbranding prescription drugs and unlicensed wholesale distribution of prescription drug. Aquino-García admitted that from 2018 through 2024, he was a member of this network of individuals and pharmacy owners who knowingly conspired to buy and sell wholesale quantities of misbranded and diverted prescription drugs for financial gain.
On November 14, 2023, a federal search warrant was executed at Aquino-García’s residence where misbranded and diverted prescription drugs were seized having a value in excess of $3.4 million. These drugs were destined to be purchased and resold via retail pharmacies in Puerto Rico.
“The defendants enriched themselves through a fraudulent scheme that cost Medicare and Medicaid over $7.6 million,” said W. Stephen Muldrow, United States Attorney for the District of Puerto Rico. “Moreover, the defendants, in clear disregard of the patients’ needs and medical conditions, distributed medications without the proper procedure and instructions on how to administer such medications. The U.S. Attorney’s Office is committed to protecting the community from people who abuse their positions to enrich themselves illegally through health care fraud.”
“Individuals who exploit federal health care programs to seek personal financial gain put the health and safety of communities at risk. Prescription drugs are intended to be distributed from the manufacturer to licensed wholesale distributors, to pharmacies, and then to patients,” stated Special Agent in Charge Naomi Gruchacz with U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Today’s indictment illustrates HHS-OIG’s staunch commitment to combating health care fraud with our law enforcement partners.”
“The FDA oversees the prescription drug supply chain so that patients and consumers can expect their prescribed medications to be safe and effective. The defendants in this case undermined the FDA safeguards designed to protect the public, introduced diverted prescription drugs into the supply chain, and compromised patient safety for personal gain,” said Special Agent in Charge Justin Fielder of the Food and Drug Administration (FDA)’s Office of Criminal Investigations Miami Field Office. “Thanks to the efforts of our FDA-OCI agents, and our HHS OIG and USAO partners, this scheme was identified, investigated and dismantled. These indictments are a clear demonstration that FDA will not stop pursuing and bringing to justice those who would put the public health at risk through their criminal actions.”
The defendants are scheduled for their initial court appearances today before U.S. Magistrate Judge Marcos E. López of the U.S. District Court for the District of Puerto Rico. If convicted, the defendants face the following sentences: up to five years in prison for the conspiracy to introduce misbranded drugs and to defraud the United States; up to 10 years in prison for the conspiracy to commit healthcare fraud and unlicensed wholesale distribution of prescription drugs; up to three years in prison for unauthorized trading partner and misbranding of prescription drugs with intent to mislead and defraud; and up to 20 in prison for theft, trafficking, and sale of pre-retail medical products. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The U.S. Department of Health and Human Services, Office of Inspector General (HHS OIG) and the U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI) are investigating the case. The collaboration and assistance of the U.S. Marshal Service and the Puerto Rico Police Bureau in executing the corresponding arrests is appreciated.
U.S. Department of Health and Human Services, Office of Inspector General Special Assistant U.S. Attorney Wallace A. Bustelo is prosecuting these cases.
Patients are encouraged to speak to their health care provider or report an adverse event to the FDA. Health care providers can report adverse events to the FDA through FDA’s online reporting portal on the FDA website. If someone is having a medical emergency, please call 911.
To report adverse events and quality control issues, please contact:
FDA’s Adverse Event Reporting Line:1-888-INFO-FDA (1-888-463-6332) and Press 2 to report to MedWatch or for instructions.
FDA MedWatch Online: https://www.accessdata.fda.gov/scripts/medwatch
To report illegal conduct, please contact:
HHS-OIG Hotline: 1-800-HHS-TIPS (1-800-447-8477) or https://tips.oig.hhs.gov
To file a voluntary self-disclosure, please access the link below:
https://oig.hhs.gov/compliance/self-disclosure-info/self-disclosure-protocol/
An indictment is merely an allegation and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
