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

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

Biden Administration invites comments on new march-in rights framework

On Friday, December 8, the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) opened for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-in...more

Federal Grants & Buy America: OMB issues final guidance for federally funded infrastructure projects

On August 23, 2023, the White House Office of Management and Budget (OMB) issued its final guidance (“Guidance”) implementing the Build America, Buy America (BABA) provisions of the Infrastructure Investment and Jobs Act...more

CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more

U.S. government bans the use of TikTok under government contracts

On June 2, 2023, the U.S. Government issued an interim rule that bans the use of the popular social media application, TikTok, from government contracting. The Department of Defense (DoD), General Services Administration...more

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

Buy American final rule: March 7 amendment

On 7 March 2022, the Federal Acquisition Regulation (FAR) Council published a final rule amending the FAR to implement a January 2021 Executive Order (EO), EO 14005, aimed to strengthen domestic preferences in Government...more

Task Force provides some flexibility for federal contractors regarding vaccine mandate requirements

On November 1, 2021, the Biden Administration issued several new frequently asked questions (FAQs) for federal contractors subject to the President’s executive order mandating COVID-19 vaccinations for covered contractor...more

Task Force announces details of federal contractor vaccine mandate

The Safer Federal Workforce Task Force (Task Force) has issued its guidance (Guidance) regarding the COVID-19 safety protocols that federal contractors must implement under President Biden’s recent Executive Order 14042. The...more

New COVID-19 Executive Order Expands Requirements for U.S. Government Contractors

Late last week, in the latest step to curb the COVID-19 pandemic, President Joseph R. Biden announced new Federal contractor employee vaccination requirements that are set to go into effect as of 15 October. The...more

White House announces COVID-19 safety measures for onsite federal contractors

On 29 July 2021, the Biden Administration announced a wave of White House programs to boost vaccination rates in the United States, including programs aimed directly at federal contractors. These initiatives, summarized in a...more

Proposed rule seeks to significantly strengthen U.S. Government “Buy American” requirements

On 30 July 2021, the FAR Council published a proposed rule to significantly strengthen “Buy American” requirements applicable to goods sold to the U.S. Government. The proposed rule promotes the procurement of goods,...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is meant to implement the “Made in America” plan...more

FDA issues list of essential medicines and countermeasures required under Buy American Executive Order

Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more

Executive Order on Combating Race and Sex Stereotyping affects government contractors and grantees

On September 22, 2020, the Trump administration issued an Executive Order (EO) on Combating Race and Sex Stereotyping, which prohibits or limits “any form of race or sex stereotyping” or “race or sex scapegoating” in...more

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more

HHS guidance confers PREP Act immunity to pharmacists for certain COVID-19 tests

On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more

To fight COVID-19, emergency Federal contracting tools streamline medical device, drug acquisition

Government needs are expanding rapidly and we expect they will continue to do so throughout this pandemic. Solicitations for products, services, and research and development efforts can be found at beta.SAM.gov using the...more

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more

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