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FDA Fraud

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Beware of Salty Snacks and Candy Containing THC

Posted  07/7/23
Stack of Multicolored Gummy Bears with One Standing
On Wednesday (July 5), the FTC and FDA jointly issued cease and desist letters to several companies selling various food products containing THC, the key psychoactive ingredient in marijuana.  In announcing the enforcement action, the government made it clear the problem is not the sale of these products.  It is how they are selling them, which according to the agencies is in almost identical packaging to many...

December 20, 2022

Cochlear implant manufacturer Advanced Bionics LLC paid $11.4 million to resolve claims brought in a whistleblower action that the company falsely stated that the radio-frequency (RF) emissions generated by some of its cochlear implant processors met international standards when it submitted pre-market approval applications to the FDA.  The company allegedly knew that the devices did not meet standards, and manipulated testing conditions to obtain passing test results.  Whistleblower David Nyberg, a former engineer at Advanced Bionics, will receive a qui tam award of $1.9 million from the federal amount of the settlement.  DOJ; USAO ED PA

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

Posted  07/9/21
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...

July 8, 2021

Medical supply company Avanos Medical Inc. entered into a deferred prosecution agreement and will pay $22.2 million to resolve charges that it sold misbranded surgical gowns, labeling the MicroCool gowns as providing the highest level of fluid and virus protection under ANSI/AAMI standards, when the company knew the gowns had never met that standard.  The government also alleged that Avanos obstructed FDA inspection efforts.  ND Tex

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

Posted  03/26/21
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
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
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
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