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
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
9/10/2021
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Competition ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare Reform ,
Hospitals ,
Life Sciences ,
Pharmaceutical Industry
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 February 17, 2021, it was reported that President Biden would nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare & Medicaid Services (CMS), the largest operating division of the U.S. Department of...more
On January 28, 2021, President Biden issued an Executive Order on Strengthening Medicaid and the Affordable Care Act, responsive to Democrats’ longstanding commitment to “roll back Trump’s health care sabotage [of the...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
Senate Elevates Bipartisan Calls for Revisions to Paycheck Protection Program -
This week Senate Republicans and Democrats have underscored the need for a number of changes to the Paycheck Protection Program (PPP)...more
5/8/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Financial Stimulus ,
Health and Safety ,
Infectious Diseases ,
Legislative Agendas ,
Loan Forgiveness ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Small Business ,
U.S. Treasury
Federal Reserve Board Announces Expanded Scope and Eligibility for the Main Street Lending Program -
The Federal Reserve Board unveiled plans yesterday to expand the scope and eligibility for the Main Street Lending...more
5/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Federal Reserve ,
Financial Stimulus ,
Health and Safety ,
Legislative Agendas ,
Main Street Lending Programs ,
New Guidance ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Trump Administration ,
Unemployment Benefits
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
House Passes $484 Billion Relief Package -
Today, the House of Representatives passed a $484 billion economic relief package in response to the Coronavirus pandemic, the Paycheck Protection Program and Health Care...more
4/24/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FDIC ,
Financial Stimulus ,
Health and Safety ,
New Legislation ,
Paycheck Protection Program (PPP) ,
Public Health ,
Relief Measures ,
State and Local Government ,
Trump Administration ,
U.S. Treasury
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
Congress Fails to Reach Agreement on Additional Dollars for Small Business and Hospitals; Agencies Act to Provide CARES Act Funding to Key Sectors -
Congressional negotiators failed to reach agreement yesterday on adding...more
4/14/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Loans ,
Federal Reserve ,
Hospitals ,
Main Street Lending Programs ,
Relief Measures ,
Small Business ,
State and Local Government ,
U.S. Treasury
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
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
Senate Negotiates Phase 3, Aims for Passage by Monday -
Senate bipartisan working groups met well into the night on Friday and throughout the day on Saturday to negotiate Phase 3 of the Coronavirus response following Senate...more
3/21/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FEMA ,
Minority-Owned Businesses ,
Relief Measures ,
SBA ,
Secretary of the Treasury ,
Small Business ,
U.S. Treasury
[co-authors: Sean Feely, Senior Public Policy Specialist and Julie E. Nolan, Senior Policy Advisor]
• On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price...more
10/1/2019
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Legislative Agendas ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Legislation ,
Rebates
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