This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
8/14/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Due Process ,
Fair Price ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part D ,
Negotiations ,
Pharmacy Benefit Manager (PBM) ,
PHRMA
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
1/2/2024
/ Appropriation ,
Artificial Intelligence ,
Clinical Laboratories ,
Congressional Oversight ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Drug Pricing ,
Fiscal Year ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicare ,
Mental Health ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Supply Shortages
Introduction -
Congress returns from the August recess with a robust agenda and limited time to pursue it. The calendar is further constrained by the September 30 deadline to pass appropriations packages or a continuing...more
9/5/2023
/ Agricultural Sector ,
Climate Change ,
Continuing Resolution ,
EBITDA ,
Energy Sector ,
Environmental Social & Governance (ESG) ,
Fair Credit Reporting Act (FCRA) ,
Federal Aviation Administration (FAA) ,
Financial Services Industry ,
Government Shutdown ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
NDAA ,
Pharmacy Benefit Manager (PBM) ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Tax Cuts and Jobs Act
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
The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more
The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more
The House and Senate convened this week to kick off the 118th Congress. Republicans control the House after four years of a Democratic majority. House Republicans have a very slim majority, with only 222 seats to the...more
1/12/2023
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Budget Resolution ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Regulatory Agenda
On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....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
On September 30, 2022, Congress enacted legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices, generic drugs and biosimilars (PDUFA,...more
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
Today, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law. The final IRA bill came together after more than 18 months of intra-party negotiations among Democrats about what legislative priorities to...more
Update on UFA Reauthorization Legislation -
As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more
The following alert provides a high level update to the August 4 Akin Gump comprehensive section-by-section report, which was published before the Senate vote-a-rama and final Senate passage. This update is being published...more
Sens. Joe Manchin (D-WV) and Chuck Schumer (D-NY) shocked Washington, D.C. when they announced an agreement around a budget reconciliation package that includes clean energy and health care provisions and tax reform. The...more
There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
In October of 2018, Congress passed the SUPPORT for Patients and Communities Act (P.L. 115-271). The comprehensive opioid treatment law passed both chambers of Congress with large bipartisan support and tackled many aspects...more
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 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