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FDA Fraud

This archive displays posts tagged as relevant to fraud on the FDA. You may also be interested in our pages:

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FDA’s Approval of Alzheimer’s Drug Highlights Need for Whistleblowers

Posted  07/9/21
By Edward Baker
stamping saying fda approved
The Food and Drug Administration (FDA) is supposed to protect American consumers from unscrupulous private actors—charlatans, snake-oil salesmen, and the like—seeking to profit by selling unproven medical “cures,” treatments, and devices to the public.  Emerging during the era of the robber barons as part of Theodore Roosevelt’s efforts to “civilize capitalism,” the FDA has prevented untold harm to...

March Madness: AstraZeneca Fudges the Clinical Trial Results for Its COVID-19 Vaccine

Posted  03/26/21
By Edward Baker
basketball hoop in basketball court
In case you haven’t been following the NCAA Men’s Basketball Tournament (or even if you have), you might be surprised to learn that the University of Hartford is poised to win it all this year—except for the fact that it lost in the first round of the tournament to Baylor University, 79-55, and has been eliminated from the competition. Likewise, in case you haven’t been following the results of COVID-19...

February 9, 2021

India-based cancer drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to pay $50 million in fines and forfeiture for failing to provide certain records to FDA investigators.  In violation of the Federal Food, Drug and Cosmetic Act, which helps ensure the purity and potency of drugs sold in the United States, FKOL actively obstructed a 2013 FDA inspection of one of its plants by removing and deleting manufacturing records.  As part of the settlement, FKOL has also agreed to implement a compliance and ethics program to prevent, detect, and correct any further violations of U.S. laws.  DOJ; USAO NV

How Whistleblowers Can Report Fraud Related to Clinical Trials

Posted  09/4/20
Microscope
The COVID-19 pandemic has highlighted the importance of government-funded scientific and medical research, including clinical trials of vaccines, treatments, and more.  We are all potentially at risk if there is fraud and abuse in clinical trials and other research. Individuals with knowledge of fraud and misconduct in federal grants and clinical trials may be able to bring a whistleblower action for that research...

Question of the Week — Is DOJ’s Blockbuster $1.4 Billion Opioid Settlement Just the Tip of the Iceberg?

Posted  07/12/19
Pill container spilled over with pills fallen out.
On July 11, DOJ announced a record-breaking $1.4 billion settlement with Reckitt Benckiser Group plc (RB Group) over allegations that its former subsidiary Indivior Inc. inflated prescriptions of its opioid-withdrawal drug Suboxone through numerous unestablished representations about the drug’s safety and addictiveness. The settlement resolves RB Group’s potential civil and criminal liability, but Indivior still...

Catch of the Week — Wound Care Device Manufacturer ACell Inc.

Posted  06/14/19
By Edward Baker
Nurse Wrapping a Wound on Mans Wrist
Our Catch of the Week goes to ACell Inc., a Maryland-based medical device manufacturer that pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to report that it had partially removed its wound-care product, MicroMatrix, from the market because it was contaminated with endotoxins, placing treated patients in danger of serious infection, even death, without informing the FDA that it...

February 22, 2019

Pharmaceutical manufacturer Lehigh Valley Technologies, Inc. will pay $4 million to resolve claims that it caused the submission of false claims through a scheme to avoid the payment of FDA new drug application (NDA) fees.  The FDA will waive such fees for a small business applicant submitting its first NDA, and had waived fees for Lehigh on an NDA in 2010.  Subsequently, in an effort to avoid $2 million in fees for a later NDA, Lehigh entered into agreements with two other companies to submit the NDAs and claim the fee exemptions, while Lehigh retained undisclosed control. USAO ED PA

October 1, 2018

Pharmaceutical distributor AmerisourceBergen Corporation will pay $625 million to the federal government and 43 states to settle claims that between 2001 and 2014 a pre-filled syringe program at one of its subsidiaries, Medical Initiatives, Inc., violated federal law.  Despite lacking the proper licensing and registration, MII opened FDA-approved sterile vials of oncology drugs, and in a non-sterile environment, pooled the medicine and transfered it into non-FDA approved pre-filled syringes which were then sold to oncology practices and physicians.  This practice allowed Amerisource to capture the "overfill" in the original FDA-approved sterile vials and produce a larger number of pre-filled syringes.  AmerisourceBergen also resolved claims that it provided unlawful kickbacks to physicians to induce them to purchase pre-filled syringes rather than vials.  The settlement resolved three qui tam actions initiated by whistleblowers Michael Mullen, Daniel Sypula, Kelly Hodge, and Omni Healthcare, Inc.; a payment of over $93 million will be made to relators. Previously, in September, 2017, AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs and agreed to pay $260 million in criminal fines and forfeitures. USAO E.D.N.Y.NY

What Would You Do? Disgrace and Conflicts in Medical Clinical Studies

Posted  09/18/18
By Jessica T. Moore
The fall and resignation of the renowned Chief Medical Officer and physician-in-chief of Memorial Sloan Kettering Cancer Center, researcher Dr. Jose Baselga, once again sound the alarm of questionable ethics, conflicts of interest, and integrity in clinical studies. Dr. Baselga is known as one of the world’s top cancer doctors, credited with new, life-saving therapies. Drug companies sponsor interested...

AstraZeneca Settles Seroquel False Claims Action -- Again

Posted  08/9/18
AstraZeneca
On August 8, 2018, AstraZeneca agreed to pay $110 million to the state of Texas to settle allegations that it promoted two of its drugs without FDA approval resulting in health risks to children, adolescents, and other state hospital patients. This case was brought by two whistleblowers under the qui tam provisions of Texas’s Medicaid Fraud Prevention Act. The whistleblowers, two former AstraZeneca employees, among...
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