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Department of Defense (DOD) Pharmaceutical Industry

Hogan Lovells

Life Sciences Procurement Update: FY2025 NDAA Would Changes to Rules of Origin for Drugs

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In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more

BakerHostetler

Updated BIOSECURE Act Scheduled For Committee Vote

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A House committee will vote May 15 on an updated version of the BIOSECURE Act, legislation that would block federal contracts to five Chinese biotechnology companies and other drugmakers with certain China-based companies in...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

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The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

Venable LLP

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

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Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

American Conference Institute (ACI)

[Event] 17th Annual “BIG FOUR” Pharmaceutical Pricing Boot Camp - May 1st - 2nd, New York, NY

Establish firm footing in the world of government contracting with this advanced course of study in Big Four pharmaceutical purchasing. ACI’s Big Four Pharmaceutical Pricing Boot Camp will introduce and reinforce core...more

Morrison & Foerster LLP

DOJ Releases False Claims Act Statistics for Fiscal Year 2022

On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter

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

McDonnell Boehnen Hulbert & Berghoff LLP

President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more

King & Spalding

Biden Administration Releases Industrial Base Reports

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Reports identify weaknesses and introduce plans to strengthen certain critical supply chains - On February 24, 2022, the Biden Administration released a Plan to Revitalize American Manufacturing and Secure Critical Supply...more

PilieroMazza PLLC

Weekly Update for Government Contractors and Commercial Businesses – February 2022

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DOJ Recovers Over $5.6 Billion From Fraud and False Claims Act Matters in FY 2021: 6 Key Takeaways - On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it had recovered more than $5.6 billion in Fiscal...more

Morrison & Foerster LLP

Theranos: The Limits of the “Fake It Till You Make It” Strategy

In the case that tested the limits of the “fake it till you make it” approach to a startup business, on January 3, 2022, a jury in the U.S. District Court for the Northern District of California convicted Elizabeth Holmes,...more

Akin Gump Strauss Hauer & Feld LLP

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

Holland & Knight LLP

Biden Administration Report Outlines Strategy to Invigorate Domestic Supply Chains

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The Biden Administration on June 8, 20201, released findings from a 100-day interagency domestic supply chain assessment of critical products and outlined a series of steps it will take in order to strengthen U.S. critical...more

Fox Rothschild LLP

$8 Million Pharmacy Fraud Case Lands 6 Behind Bars

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A recent health care fraud conspiracy case resulted in federal prison sentences for six participants, serving as a warning to pharmacy owners and their employees. The Case- Mohamed Abdalla is a licensed pharmacist who...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 8

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In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Manatt, Phelps & Phillips, LLP

COVID-19 Vaccine Distribution: Key Challenges and Outstanding Questions

On September 16, 2020, the Trump Administration issued, for the first time, a planning framework for allocation and distribution of an eventual COVID-19 vaccine (the Federal Distribution Strategy). After briefly summarizing...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

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On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

McDermott Will & Emery

August 13, 2020, Deadline for Healthcare Providers and Life Sciences Federal Contractors: Ban on Use of Certain Chinese...

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Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

WilmerHale

False Claims Act: 2019 Year-in-Review

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The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more

Orrick, Herrington & Sutcliffe LLP

New Syria, North Korea and Other Sanctions Provisions Enacted as Parts of the National Defense Authorization Act for Fiscal Year...

On December 20, 2019, President Trump signed into law the National Defense Authorization Act for Fiscal Year 2020 (“NDAA 2020”), which includes numerous sanctions-related provisions. The law includes the previously introduced...more

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