For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
10/8/2021
/ Biden Administration ,
Biomedical Advanced Research and Development Authority (BARDA) ,
China ,
Competition ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
NDAA ,
Pharmaceutical Industry ,
Supply Chain
Key Points
- On December 27, 2020, the new stimulus package appropriating an additional $284.45 billion for the PPP was signed into law.
- The categories of eligible uses for loan proceeds and forgiveness are...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
- The Department of Justice (DOJ) will focus its civil enforcement activity on fraud and other illegal actions relating to COVID-19, including with respect to CARES Act stimulus programs and consumer products marketed for use...more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Private Equity Firms ,
Qui Tam
On Friday, April 24, 2020, the Small Business Administration (SBA) published an Interim Final Rule (IFR) governing the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief and Economic Security Act (CARES Act). In...more
- The government has pledged to prioritize investigations and prosecutions regarding alleged frauds related to coronavirus programs.
- The False Claims Act is the government’s primary enforcement tool to prosecute alleged...more
- The Paycheck Protection Program (PPP), contained within the stimulus package signed by President Trump on March 27, 2020, creates a $349 billion loan facility to help “small” businesses make payroll and pay certain other...more
Loans Under Paycheck Protection Program (Section 1102) -
Section 1102 provides $350 billion for expedited individual loans up to $10 million through approved lenders that are guaranteed 100 percent by the U.S. government....more
The Defense Production Act (DPA) of 1950 (50 U.S.C. §§ 4501 et seq.) grants the President broad authority to prioritize and allocate health resources. This includes two very separate and distinct authorities to (1) “require...more