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
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
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
Through ADG Insights, we share with you the top legal and political issues affecting the aerospace, defense, and government services (ADG) industry. Our ADG industry team monitors the latest developments to help our clients...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
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
Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate...more
5/12/2017
/ Billing ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Veterans Affairs ,
Federal Supply Schedule (FSS) ,
Healthcare Facilities ,
Indian Health Service (IHS) ,
Medicaid ,
Medicaid Reimbursements ,
Native American Issues ,
Prescription Drugs ,
Regulatory Standards
While contractors (and their HR departments) dodged a serious bullet with Trump’s recent invalidation of the 2016 FAR blacklisting rule, they need to be alert to a new HR-related compliance requirement as a result of a rule...more
Earlier this week, President Trump put the final nail in the coffin for the former administration’s “blacklisting” rule, officially known as the Fair Pay and Safe Workplaces Final Rule. The move means federal contractors will...more
Earlier this week, on March 6, 2017, the Senate passed a joint resolution disapproving the Fair Pay and Safe Workplaces Final Rule (the “Rule”), which mandated contractor reporting of labor law violations, and had earned the...more