Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more
9/1/2023
/ Animal Drugs ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Opioid ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Supply Shortages ,
Telehealth ,
Transparency
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
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
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...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 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
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• 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