With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more
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
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...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
Leaders of Small Business Committee Reach Consensus on Bill to Extend PPP Loan Deadline, Senate Fails to Clear Measure by Unanimous Consent as Phase 4 Negotiations Likely to Dominate June -
Bipartisan leaders of the Senate...more
5/26/2020
/ Agricultural Sector ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Agriculture ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Farm Workers ,
Farms ,
Federal Funding ,
Federal Reserve ,
Filing Deadlines ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Infectious Diseases ,
Legislative Agendas ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Small Business ,
Small Business Loans ,
Supply Chain ,
Trump Administration ,
USDA
White House Unveils Testing Blueprint, Senate Slated to Return Monday, House Return Uncertain -
President Trump unveiled the Administration’s blueprint for state testing plans and rapid response programs on Monday,...more
4/29/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Legislative Agendas ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
State of Emergency ,
Trump Administration
Congress, Administration Reach $484 Billion Deal for Phase 3.5 -
Yesterday, congressional Democrats and Republicans reached a $484 billion deal with the Trump Administration for “Phase 3.5” of the coronavirus response to,...more
4/22/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Legislative Agendas ,
Medical Testing ,
Paycheck Protection Program (PPP) ,
Public Health ,
Relief Measures ,
State and Local Government ,
Trump Administration ,
U.S. Treasury
President Trump Unveils Framework for “Opening Up America Again” -
President Trump yesterday provided recommendations to governors for reopening parts of the U.S. economy. The guidance, dubbed “Opening Up America Again,”...more
4/17/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Public Health ,
Relief Measures ,
Trump Administration ,
U.S. Treasury
Senate Considers Phase 3, Aims for Passage As Soon As Possible -
With more states issuing orders for residents to stay at home and businesses to close, the Senate failed to agree to a procedural motion on Phase 3 of the...more
3/22/2020
/ Business Closures ,
CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Department of Transportation (DOT) ,
Department of Veterans Affairs ,
Donald Trump ,
FEMA ,
Food and Drug Administration (FDA) ,
Medicare ,
Personal Protective Equipment ,
SBA ,
Shelter-In-Place ,
SNAP Program ,
U.S. Commerce Department ,
US Department of State
Recent months have seen a flurry of activity in Congress on prescription drug pricing and surprise medical bills as lawmakers seek to address rising consumer health care costs. Several House and Senate committees have...more
8/8/2019
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
HELP ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Sovereign Immunity ,
Surprise Medical Bills ,
Tribal Governments ,
Trump Administration
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO