On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
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
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 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
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 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
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
With reports of widespread shortages of personal protective equipment (PPE) and ventilators and the COVID-19 pandemic continuing to expand nationwide, the Trump Administration has turned to the Defense Production Act (DPA) –...more
4/9/2020
/ Coronavirus/COVID-19 ,
Defense Production Act ,
Exports ,
Federal Contractors ,
FEMA ,
Imports ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Supply Chain
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