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 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
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
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
Recently, 24 June 2019, the U.S. Supreme Court issued a landmark decision, Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 915 (2019), that overturns a half-century of precedent and significantly expands the ability of...more
6/26/2019
/ Appeals ,
Confidential Information ,
Congressional Intent ,
Corporate Counsel ,
Exemptions ,
FOIA ,
Food Marketing Institute v Argus Leader Media ,
Motion to Compel ,
Private Commercial or Financial Information ,
Protected Disclosures ,
Reversal ,
SCOTUS ,
SNAP Program ,
Statutory Interpretation ,
Substantial-Competitive-Harm Test ,
Trade Secrets ,
USDA
On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more
8/28/2017
/ Buy America ,
Buy American Act ,
Comment Period ,
Executive Orders ,
Free Trade Agreements ,
Information Technology ,
Manufacturers ,
Material Suppliers ,
Military Goods ,
Pharmaceutical Industry ,
Procurement Guidelines ,
Regulatory Oversight ,
Software ,
Suppliers ,
Supply Chain ,
Trump Administration ,
USTR
In a case involving medical methods invented by two Nobel laureates, the U.S. Court of Appeals for the Federal Circuit has ruled that sovereign immunity prevents a third researcher from pursuing his claim of co-inventorship...more
4/27/2017
/ Bayh-Dole Act ,
Educational Institutions ,
Genetic Materials ,
Inventions ,
Inventors ,
Joint Inventors ,
Jurisdiction ,
Patents ,
Research Funding ,
Royalties ,
Scientific Research ,
Sovereign Immunity ,
Universities
On April 18, 2016, President Donald Trump signed the executive order “Buy American and Hire American” aimed at maximizing the federal government’s use of goods, products, and materials produced in the United States. The E.O....more