The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more
2/21/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Product Packaging ,
Proposed Rules ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements
UPDATE: As of 5:00 PM EST on January 28, a federal judge has temporarily blocked the Trump administration from enforcing the freeze detailed below. This situation is ongoing and clients should still prepare accordingly....more
1/29/2025
/ Compliance ,
Cooperative Agreements ,
Diversity and Inclusion Standards (D&I) ,
Executive Orders ,
Federal Funding ,
Government Agencies ,
Grants ,
Loans ,
OMB ,
Regulatory Requirements ,
Trump Administration
Congress returned to Washington this week with just five weeks left in this year’s legislative calendar. With a Continuing Resolution (CR) that expires December 20, 2024, either a year-end spending package or a new Continuing...more
11/18/2024
/ Audits ,
Consolidated Appropriations Act (CAA) ,
Continuing Resolution ,
Enforcement ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Investment ,
Jurisdiction ,
Lame Duck Session ,
Medicare ,
Mental Health ,
Pharmacy Benefit Manager (PBM) ,
Physician Fee Schedule ,
Telehealth ,
Transparency ,
Vouchers
Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.
The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more
9/11/2024
/ Biotechnology ,
China ,
Competition ,
Department of Defense (DOD) ,
Exceptions ,
Federal Acquisition Regulations (FAR) ,
Foreign Adversaries ,
Jurisdiction ,
Manufacturers ,
National Security ,
OMB ,
Presidential Veto ,
Proposed Legislation ,
Research and Development ,
Retaliation ,
Safe Harbors ,
Supply Chain ,
Waivers
On January 25, 2024, Representative Jan Schakowsky (D-IL-09), Ranking Member of the House Innovation, Data, and Commerce Subcommittee and former Chairwoman of the Consumer Protection Subcommittee of the House Energy and...more
On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used...more
11/8/2023
/ Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Governance Standards ,
Innovation ,
Personal Information ,
Privacy Laws ,
Risk Mitigation ,
Safety Standards ,
Technology Sector
President Biden has repeatedly discussed the need to onshore or re-shore U.S. manufacturing to improve national security and competitiveness. The war in Ukraine and worldwide supply chain issues created by the COVID-19...more
The dust from the 2022 Midterm Elections has settled and the 118th Congress has begun. Republicans were successfully able to flip control of the House and now have a 222-212 majority with one vacancy to be filled. Democratic...more
1/18/2023
/ Child Tax Credit ,
Climate Change ,
Communications Decency Act ,
Congressional Review Act ,
Consolidated Appropriations Act (CAA) ,
Department of Energy (DOE) ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
General Elections ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Infrastructure ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicare ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Rapanos v US ,
SALT ,
State Elections ,
Tax Cuts and Jobs Act ,
US Army Corps of Engineers ,
Waters of the United States
As a rule, a Member, officer, or employee may not accept any gift, except as the rule provides (relevant exceptions listed below). Members-elect are subject to the Gift Rule when their pay and allowances begin....more
As the final votes of the 2022 Midterm Elections are counted, Republicans have taken back control of the House of Representatives, while the Democrats will retain control of the Senate. Both chambers will be held by extremely...more
11/18/2022
/ Biden Administration ,
Clean Energy ,
Cybersecurity ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Election Results ,
EU ,
Healthcare Reform ,
Legislative Agendas ,
Medicare Part D ,
Popular ,
Regulatory Agenda ,
Tax Cuts and Jobs Act ,
Tax Reform ,
Trade Relations
Votes in the 2022 Midterm Elections are still being tallied. It will likely take several more days, if not weeks, to be able to confirm who will hold the majority in the House and Senate.Please note that House, Senate, and...more
11/11/2022
/ American Rescue Plan Act of 2021 ,
Budgets ,
Election Results ,
Food and Drug Administration (FDA) ,
Funding ,
General Elections ,
Inflation Reduction Act (IRA) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Lame Duck Session ,
Medicare ,
Mental Health ,
NDAA ,
Physician Fee Schedule ,
SECURE Act ,
State Elections ,
Tax Cuts and Jobs Act
The 2022 Midterm Elections are a little over one month away and the races are tightening up. Democrats have seen their fortunes improve with a string of legislative victories and improving poll numbers for President Joe...more
10/3/2022
/ Community Development ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Federal Elections ,
FEMA ,
Food and Drug Administration (FDA) ,
Political Candidates ,
Political Parties ,
State Elections ,
U.S. House ,
Ukraine ,
User Fees
Late Wednesday evening, Senator Manchin released the closely guarded text on his proposal to reform domestic energy permitting. This legislation was the subject of a handshake agreement between Manchin, Senator Schumer,...more
The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device applications, are set to expire on October 1, 2022. These include the Prescription Drug...more
As September gets underway and Washington returns from a busy recess, important deadlines loom. August saw the introduction and passage of the Inflation Reduction Act, the Biden Administration’s announcement of student debt...more
President Biden has now signed into law the $700 billion Inflation Reduction Act of 2022, a package comprised of health care, climate change, and taxation policy reforms. It is a scaled-back version of the Build Back Better...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more
7/8/2022
/ BsUFA ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
GDUFA ,
HELP ,
Infrastructure ,
Medicaid ,
Medical Device User Fee Program (MDUFA IV) ,
PDUFA ,
Proposed Legislation ,
Public Health Emergency ,
SCOTUS ,
Surprise Medical Bills ,
U.S. Treasury ,
User Fees
Unexpected events last month re-energized two key policy debates. In early May, a leaked draft opinion by Justice Samuel Alito showed that the Supreme Court is poised to overturn Roe v. Wade in its decision of Dobbs v....more
6/1/2022
/ America Competes Act ,
BsUFA ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Climate Change ,
Department of Health and Human Services (HHS) ,
Infrastructure Investment and Jobs Act (IIJA) ,
Medicaid ,
Medical Device User Fee Program (MDUFA IV) ,
National Institute of Health (NIH) ,
PDUFA ,
Primary Elections ,
Public Health Emergency ,
Regulatory Agenda ,
Roe v Wade ,
SAMHSA ,
SCOTUS ,
Semiconductors
Congress recently returned from its two-week recess with an extensive to-do list. Between now and the August recess, the House will be in session for a total of 32 legislative days, and the Senate will be in for 54...more
5/3/2022
/ America Competes Act ,
BsUFA ,
Centers for Disease Control and Prevention (CDC) ,
Climate Change ,
Coronavirus/COVID-19 ,
Corporate Taxes ,
FDA Reauthorization Act ,
GDUFA ,
Immigration Reform ,
Medical Device User Fee Program (MDUFA IV) ,
Mental Health ,
PDUFA ,
Price Inflation ,
SAMHSA ,
Tax Code
While Congress has a two-week recess in April, there are many priority items on the agenda this month. Less than two weeks after signing the Fiscal Year (FY) 2022 spending package, President Biden released his budget for FY...more
4/4/2022
/ America Competes Act ,
BsUFA ,
Budgets ,
Centers for Disease Control and Prevention (CDC) ,
Department of Energy (DOE) ,
Energy Sector ,
Food and Drug Administration (FDA) ,
GDUFA ,
Government Shutdown ,
Investment Tax Credits ,
Medical Device User Fee Program (MDUFA IV) ,
Mental Health ,
National Institute of Health (NIH) ,
NATO ,
Nominations ,
Oil & Gas ,
PDUFA ,
Public Health Emergency ,
Russia ,
SAMHSA ,
Semiconductors ,
SFC ,
Ukraine
On March 15, 2022, the Senate Health, Education, Labor and Pensions Committee (HELP) held a full committee markup to offer several amendments and vote on S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New...more
Tuesday night, President Joe Biden spoke to Congress in his first State of the Union address. In an hour long speech, President Biden covered a variety of topics and urged Congress to pass numerous pieces of legislation....more
3/3/2022
/ Affordable Care Act ,
American Rescue Plan Act of 2021 ,
Coronavirus/COVID-19 ,
Electric Vehicles ,
Healthcare ,
Infrastructure Investment and Jobs Act (IIJA) ,
Joe Biden ,
Manufacturers ,
Petroleum ,
State of the Union ,
Tax Cuts and Jobs Act ,
Tax Reform ,
Ukraine
The first day of spring is right around the corner and so are deadlines for congressional appropriations requests. This month, lawmakers are racing against the clock to fund the government and President Biden looks to...more
3/1/2022
/ Asset Freeze ,
Biden Administration ,
Coronavirus/COVID-19 ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Economic Sanctions ,
Environmental Protection Agency (EPA) ,
Federal Budget ,
Infrastructure ,
National Institute of Health (NIH) ,
Nominations ,
Russia ,
SCOTUS ,
SWIFT ,
Ukraine ,
USAID
The first year of the Biden Administration marked the passage of major spending packages, including the American Rescue Plan and the Infrastructure Investment and Jobs Act. Yet, with President Biden’s social spending package,...more
2/28/2022
/ American Rescue Plan Act of 2021 ,
Biden Administration ,
CTFC ,
Department of Justice (DOJ) ,
Environmental Protection Agency (EPA) ,
Federal Trade Commission (FTC) ,
FEMA ,
OSHA ,
Pharmacy Benefit Manager (PBM) ,
Securities and Exchange Commission (SEC) ,
USDA