Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
9/8/2022
/ Biden Administration ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Mental Health ,
New Legislation ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Public Safety ,
State and Local Government ,
Substance Abuse ,
Telehealth
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
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
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
[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