Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more
Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more
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
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
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
Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
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
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
COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
Outlook for This Week in the Nation's Capital - Kavanaugh Vote. The Senate was previously planning to tee up the final vote on Kavanaugh over the weekend, but the vote on the floor has been delayed a week to accommodate a...more
Outlook for This Week in the Nation's Capital - Senate Appropriations. The Senate is planning to begin work today on its minibus package that contains the defense and labor, health, and education appropriations bills. ...more
Outlook for This Week in the Nation's Capital - Appropriations on Senate Floor. This week, the Senate plans to take up a three-bill appropriations package, commonly referred to as a “minibus”, including Military...more
Outlook for This Week in the Nation's Capital - Farm Bill Re-vote? Last week’s vote on the farm bill failed after the Freedom Caucus refused to support the measure. A roll call vote on the motion to reconsider was postponed...more
Short-term Continuing Resolution Likely Needed to Fund Government Past December Deadline: Republicans are focused on tax reform through Thanksgiving, and when lawmakers return from the upcoming holiday recess, they will have...more
Hurricane Supplemental Includes $29B for Disaster Aid and Flood Insurance: Of the $29B, the National Flood Insurance Program will receive $16B to pay flood claims. The House plans to pass the bill next week and the Senate the...more
This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more