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
Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more
On 28 March, the U.S. Commerce Department, Bureau of Industry and Security (BIS) published a list of entities that have been identified as having made a boycott-related request in order to help U.S. companies, including...more
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
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
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
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
In February, the Office of Management and Budget (OMB) proposed new Buy America regulations for Federal grants, to implement the Build America, Buy America (BABA) Act signed into law on November 15, 2021. BABA required that...more
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
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
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
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
9/27/2021
/ Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Employees ,
Infectious Diseases ,
OSHA ,
Popular ,
Vaccinations ,
Workplace Safety
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
9/14/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Employees ,
Infectious Diseases ,
Minimum Wage ,
Vaccinations ,
Wage and Hour ,
Workplace Safety
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
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
8/4/2021
/ Biden Administration ,
Buy America ,
Buy American Act ,
Buy American and Hire American ,
Department of Defense (DOD) ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Made in the USA ,
Manufacturers ,
Proposed Rules ,
Public Meetings ,
Supply Chain
Through Aerospace & Defense Insights, we share with you the top legal and political issues affecting the aerospace and defense (A&D) industry. Our A&D industry team monitors the latest developments to help our clients stay in...more
Last week, the White House Office of Management and Budget issued guidance to federal agencies implementing a January executive order that aimed to strengthen American industry through changes to federal contract law that...more
Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for semiconductor manufacturing and advanced packaging,...more
6/11/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Executive Orders ,
Goods or Services ,
Manufacturers ,
Minerals ,
Pharmaceutical Industry ,
Semiconductors ,
Supply Chain ,
Unfair or Deceptive Trade Practices ,
USTR
On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights...more
5/12/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Infectious Diseases ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Pharmaceutical Industry ,
Popular ,
TRIPS Agreement ,
Vaccinations ,
WTO
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
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
1/27/2021
/ Biden Administration ,
Buy America ,
Country of Origin ,
Critical Infrastructure Sectors ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Procurement Systems ,
Information Technology ,
Manufacturers ,
Regulatory Reform ,
Suppliers ,
Supply Chain
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
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
Tuesday, 20 October 2020 -
President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more
10/20/2020
/ CDRH ,
Coronavirus/COVID-19 ,
Dr. Anthony Fauci ,
Emergency Use Authorization (EUA) ,
Executive Orders ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Government Lockdown ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Relief Measures ,
Supply Chain ,
Trump Administration
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
9/28/2020
/ Bias ,
Civil Rights Act ,
Deregulation ,
Diversity ,
Diversity and Inclusion Standards (D&I) ,
Employee Training ,
Executive Orders ,
Federal Contractors ,
OFCCP ,
Race Relations ,
Regulatory Reform ,
Sexual Stereotyping ,
Title VII ,
Trump Administration