Wednesday, December 28, 2022

 

FDA Guidance on Drug Compounding for Veterinarians And ...

6 days ago — FDA guidance for veterinarians, state-licensed pharmacies and federal facilities regarding compounding animal pharmaceuticals will take effect April 2023.

 

 

Thursday, December 22, 2022

 

Qualgen and FDA Reach Mutual Agreement

2 days ago — ... compliance with the Federal Food, Drug and Cosmetic Act (FDCA). ... to the company continuing to compound its terminally sterilized compounded drug ..

District Court Orders Oklahoma Drug Compounder in Edmond Oklahoma to Comply with Federal Food, Drug, and Cosmetic Act

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Monday, December 19, 2022

District Court Orders Oklahoma Drug Compounder to Comply with Federal Food, Drug, and Cosmetic Act

A federal court today issued an order prohibiting Qualgen LLC, an Oklahoma company, Shaun P. Riney, Qualgen’s Chief Executive Officer, and Jasen Lavoie, Qualgen’s Director of Quality, from manufacturing and distributing drugs that are not in compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).

In a civil complaint filed on Dec. 6, the United States alleged that Qualgen, Riney, and Lavoie violated the FDCA at the company’s facilities in Edmond, Oklahoma, by manufacturing and distributing adulterated drugs. As an outsourcing facility registered with the U.S. Food and Drug Administration (FDA), Qualgen makes and distributes sterile drug products, including Bio-Identical Hormone Replacement Therapy pellets (testosterone, estradiol, and testosterone/anastrozole). The United States alleged that the defendants violated the FDCA by, among other things, failing to follow written procedures applicable to the quality control unit, failing to reject drug products that did not meet specifications, and failing to follow appropriate procedures in handling complaints about its drug products. The complaint also alleged that the FDA inspected the company’s facilities five times, in 2015, 2017, 2018, 2021, and 2022, and that many of the violations were repeat violations the FDA had identified in earlier inspections.

The FDCA’s current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which their drugs are manufactured, processed, packed, and held, to ensure that the drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are deemed adulterated under the FDCA. According to the United States’ complaint, the FDA issued Qualgen several warnings, including during meetings with the FDA and in a warning letter to the company in 2016, regarding alleged deficiencies at its facilities.

“Drugs compounded in outsourcing facilities must be manufactured in conformance with applicable regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against compounding drug manufacturers who fail to abide by laws designed to protect public health.”

“Failure to manufacture drugs in strict compliance with FDA requirements endangers the very people who need and rely on the quality of those medications,” said U.S. Attorney Robert J. Troester for the Western District of Oklahoma. “We gladly partner with the FDA to enforce their regulations in order to ensure public safety is maintained in the pharmaceutical manufacturing and compounding process.”

“While drugs compounded by outsourcing facilities are not subject to pre-market review and approval by the FDA for safety and effectiveness, they must comply with rigorous manufacturing quality assurance requirements,” said Acting Director Jill P. Furman, J.D. of the FDA’s Center for Drug Evaluation and Research Office of Compliance. “The FDA’s commitment to ensuring compliance with current good manufacturing practice requirements is a critical protection for patients. We will remain vigilant and hold all manufacturers accountable to best protect the public health.”

Without admitting or denying the allegations in the complaint, the defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and prohibits, among other things, the defendants from manufacturing, compounding, processing, labeling, holding, or distributing adulterated drugs.

Senior Trial Attorney Natalie N. Sanders of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Ronald R. Gallegos for the Western District of Oklahoma handled this matter, with the assistance of Senior Counsel Paige H. Taylor of the FDA’s Office of the Chief Counsel.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.

The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.

Topic(s): 
Consumer Protection
Component(s): 
Press Release Number: 
22-1387
Updated December 19, 2022

 

Wednesday, December 21, 2022

 DEA alleges startup Truepill illegally dispensed Adderall, prescription stimulants

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 PĂ©rez 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.

Topic(s): 
Opioids
Financial Fraud
Health Care Fraud
Component(s): 

 

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.

Read more on www.justice.gov

 

Pharmscript Of KS LLC Agrees To Pay $3 Million To Resolve Allegations That It Improperly Dispensed Controlled Substances At Long-Term Care Facilities

 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.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
22-462
Updated December 12, 2022

 

Leaders talk adverse events reporting with FDA - APC

3 days ago — Alliance for Pharmacy Compounding. ... than 50 percent of their compounded drugs out of state and implementing reporting of adverse events by all 503As,