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
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
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
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 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
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
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
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
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
8/10/2020
/ Buy American Act ,
Counterfeit Goods Regulation ,
Countermeasures ,
Department of Defense (DOD) ,
Environmental Protection Agency (EPA) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Supply Chain ,
Trump Administration ,
USTR
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
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
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
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
3/20/2020
/ Coronavirus/COVID-19 ,
Country of Origin ,
Defense Production Act ,
Emergency Management Plans ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Medical Devices ,
Medical Supplies ,
Relief Measures ,
State of Emergency ,
Trump Administration
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
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
2/12/2020
/ Administrative Proceedings ,
Appeals ,
Bid Protests ,
Bid Solicitation ,
Country of Origin ,
Court of International Trade ,
Department of Veterans Affairs ,
Federal Acquisition Regulations (FAR) ,
Federal Procurement Systems ,
Generic Drugs ,
India ,
Made in the USA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Statutory Interpretation ,
Supply Contracts ,
Trade Agreements Act
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
8/14/2019
/ Chain of Distribution ,
China ,
Defense Sector ,
Department of Justice (DOJ) ,
Department of Veterans Affairs ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Malaysia ,
Medical Devices ,
Regulatory Requirements ,
Regulatory Violations ,
Supply Chain ,
Trade Agreements Act ,
Unlawful Distribution