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Medical Research Department of Justice (DOJ)

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Benesch

The “China Initiative” Just Won’t Die - Recent DOJ Settlement Highlights the Lasting Effect of Trump-Era Policy on Health Care...

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In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more

Vicente LLP

4 Major Implications of Cannabis Moving to Schedule III

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After 50 years of being on the most restrictive schedule alongside drugs like heroin and PCP, the DEA will move to reschedule marijuana in Schedule III, where the plant’s medical benefits will finally be recognized by the...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

Husch Blackwell LLP

All the Outcomes of a Marijuana Reschedule

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Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more

Health Care Compliance Association (HCCA)

DOJ: Stanford FCA Case Involved Failures to Disclose Foreign Support From Seven Countries

Report on Research Compliance 20, no. 11 (November, 2023) It wasn't just China. China is among the countries whose support for Stanford University investigators wasn’t reported to five federal research funding agencies,...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

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On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

McGlinchey Stafford

From Schedule I to Schedule III: Potential Shift in Marijuana’s Legal Status

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Major news broke on August 30, 2023, as the U.S. Department of Health and Human Services (HHS) announced that it would recommend moving marijuana from Schedule I to Schedule III, as first reported by Riley Griffin for...more

Husch Blackwell LLP

DOJ Continues to Eye Clinical Researchers (and the Universities and Hospitals Employing Them)

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Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.” The article is the latest in a sequence of alarms...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 2. In This Month's E-News: February 2022

Report on Research Compliance 19, no. 2 (January 27, 2022) - While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 10. In This Month’s E-News: October 2021

Report on Research Compliance 18, no. 10 (October, 2021) - An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

WilmerHale

DOJ’s “China Initiative” Falters

WilmerHale on

When Anming Hu, an engineering professor at the University of Tennessee, Knoxville (“UTK”) was indicted in February 2020 on charges related to his alleged failure to disclose ties to a state-run Chinese university, the case...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 5. In This Month’s E-News: May 2021

Report on Research Compliance 18, no. 5 (May 2021) - Rep. Kathy Castor, D-Florida, has relaunched the bipartisan Congressional Academic Medicine Caucus with new co-chair Rep. David McKinley, R-West Virginia, who replaced...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 11. In This Month's E-News: November 2020

Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 6. In This Month's E-News: June 2020

Report on Research Compliance 17, no. 6 (June 2020) - A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more

Morgan Lewis

Higher Education Community Faces Federal Scrutiny of Financial Ties to China

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Both individuals and higher education institutions could face criminal and civil liability if they are not in compliance with federal law in the administration of federal grants and expenditure of federal research dollars, as...more

White & Case LLP

For COVID-19 Competitor Collaborations, DOJ Antitrust Division’s “Business Review Letter” Offers Easy and Likely Effective...

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On April 4, 2020, the Antitrust Division of the Department of Justice issued its first Business Review Letter under the DOJ-FTC joint expedited COVID-19 competitor collaboration review procedures, blessing several medical...more

Bradley Arant Boult Cummings LLP

Decoding DOJ’s Crackdown on Genetic Testing: High-Profile Indictments and Practical Takeaways for the Cancer and Pharma Genomics...

In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been...more

King & Spalding

DOJ Announces FCA Settlement with NIH-Funded Institute Related to Disclosure of Foreign Influence in Research

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The Department of Justice (DOJ) recently announced that it reached a $5,500,000 settlement with a biomedical research institute that received NIH grant funding–the Van Andel Research Institute (VARI)–to resolve allegations...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 3. In This Month's E-News: March 2020

Report on Research Compliance 17, no. 3 (February 20, 2020) - Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more

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