This week, the government shutdown entered its fifth week and, on Nov. 4, 2025, became the longest in history, beating a 34-day-plus record set during President Donald Trump's first term. Meanwhile, the Open Enrollment Period...more
11/5/2025
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Public Service Loan Forgiveness program (PSLF program) ,
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State Elections ,
Tariffs ,
Transgender
The federal government shutdown has now entered its fourth week, making it the third longest in U.S. history. Despite mounting pressure from both parties, no agreement has been reached to reopen the government. Lawmakers...more
10/29/2025
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Artificial Intelligence ,
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Generic Drugs ,
Government Shutdown ,
Pharmaceutical Industry ,
Section 301 ,
Senate Committees ,
Supply Chain
The federal government is in the midst of a shutdown that is centrally focused on a dispute regarding the level of financial assistance that should be provided to individuals and families purchasing health insurance plans on...more
10/28/2025
/ Affordable Care Act ,
American Rescue Plan Act of 2021 ,
Department of Health and Human Services (HHS) ,
Federal Health Insurance Exchanges ,
Government Shutdown ,
Health Insurance ,
Inflation Reduction Act (IRA) ,
Insurance Industry ,
Open Enrollment ,
Public Health Insurance Marketplace ,
Tax Credits
As the government shutdown enters its fourth week, there is no clear end in sight. Democrats continue to insist that any bill to reopen and fund the government include an extension of the advanced premium tax credits (APTCs)...more
10/22/2025
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Centers for Medicare & Medicaid Services (CMS) ,
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Department of Health and Human Services (HHS) ,
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Executive Orders ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Layoffs ,
Medicaid ,
Open Enrollment ,
Pregnancy ,
Premium Subsidies ,
Regulatory Agenda ,
Section 340B ,
Subsidies ,
Tax Credits ,
Vaccinations ,
Voluntary Reduction in Force
The U.S. Food and Drug Administration (FDA) announced in June 2025 the establishment of a new Commissioner's National Priority Voucher (CNPV) program and began accepting applications, promising those selected an accelerated...more
10/22/2025
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Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements
The government is a week into the first federal shutdown in seven years. Congressional negotiations remain at an impasse, and lawmakers have repeatedly failed to pass a stopgap spending bill despite the U.S. Senate holding...more
10/8/2025
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Affordable Care Act ,
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Centers for Medicare & Medicaid Services (CMS) ,
Continuing Resolution ,
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Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
Medicare Advantage ,
Prescription Drugs ,
Senate Committees
In accordance with President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212 to create a commission to Make America Healthy Again (MAHA), the Commission released its inaugural report, "The MAHA Report: Making Our...more
9/18/2025
/ Agribusiness ,
Chemicals ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Information Reports ,
Pesticides ,
Public Health ,
Public Policy ,
Regulatory Reform ,
USDA
Extending funding for the federal government beyond Sept. 30, 2025, will be at the top of the U.S. Congress' agenda this week. Republicans in the U.S. House of Representatives are expected to release the text for a continuing...more
9/17/2025
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Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
MACPAC ,
Medicare ,
New Guidance ,
New Legislation ,
No Surprises Act (NSA) ,
Prescription Drugs ,
SAMHSA ,
Telehealth ,
USDA
The Make America Healthy Again (MAHA) Commission was established by President Donald Trump's Feb. 13, 2025, executive order (EO) 14212 titled "Establishing the President's Make America Healthy Again Commission." As Holland &...more
9/15/2025
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Healthcare ,
Information Reports ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Research and Development
Both chambers of the U.S. Congress are in session this week, with the U.S. House of Representatives and U.S. Senate set to resume a packed schedule of hearings and legislative markups. While much of the attention in the House...more
9/10/2025
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Appropriations Bill ,
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Centers for Medicare & Medicaid Services (CMS) ,
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Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare ,
Medicare ,
NDAA ,
New Legislation ,
Prior Authorization ,
Senate Committees
The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The...more
U.S. Congress returns from the August 2025 recess for a short session. Both chambers will be forced to address a looming to-do list, namely potentially extending government funding beyond Sept. 30, 2025....more
9/4/2025
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Artificial Intelligence ,
Centers for Disease Control and Prevention (CDC) ,
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Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
National Institute of Health (NIH) ,
Proposed Rules ,
Public Health ,
Tariffs ,
USAID ,
Vaccinations
This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...more
7/30/2025
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Health Care Providers ,
Health Insurance ,
Medicaid ,
New Legislation ,
Proposed Legislation ,
Senate Confirmation Hearings ,
Trade Agreements
With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more
7/22/2025
/ Affordable Care Act ,
Appropriation ,
CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Investigations & Hearings ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medicare ,
National Institute of Health (NIH) ,
New Legislation ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
7/16/2025
/ Biologics ,
Consumer Protection Laws ,
Drug Pricing ,
Enforcement Actions ,
Expedited Approval Process ,
Expedited FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Recalls ,
Proposed Regulation ,
Public Policy ,
Regulatory Agenda ,
Regulatory Reform
The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more
7/15/2025
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Congressional Investigations & Hearings ,
Consumer Financial Protection Bureau (CFPB) ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Fair Credit Reporting Act (FCRA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Legislative Agendas ,
Medical Debt ,
Pharmacy Benefit Manager (PBM) ,
Proposed Legislation ,
Public Health ,
Public Policy ,
Senate Committees ,
Trump Administration ,
Vaccinations
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
7/10/2025
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Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
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Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
HRSA ,
Medicaid ,
Medicare ,
New Legislation ,
SCOTUS ,
Section 340B ,
Transgender ,
Trump Administration
The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more
7/1/2025
/ Chemicals ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
GRAS ,
Proposed Rules ,
Public Health ,
REACH ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Assessment ,
Rulemaking Process ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
Staff from U.S. Senate committees held meetings with the Senate parliamentarian over the weekend of June 20-22, 2025, to complete the "Byrd bath," a process by which committee staff make their case to the Senate...more
6/25/2025
/ Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Proposed Legislation ,
Senate Committees
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more
The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more
6/19/2025
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Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Risk Assessment ,
Supply Chain ,
Trump Administration
The U.S. Senate is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more
6/18/2025
/ Budget Reconciliation ,
Congressional Committees ,
Congressional Investigations & Hearings ,
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Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medical Research ,
Medicare ,
MedPAC ,
National Institute of Health (NIH) ,
Proposed Legislation
The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more
6/11/2025
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Biden Administration ,
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DEA ,
Department of Health and Human Services (HHS) ,
EMTALA ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
Proposed Legislation ,
Senate Committees ,
Trump Administration
The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more
5/27/2025
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Chemicals ,
Clinical Trials ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Information Reports ,
Pesticides ,
Prescription Drugs ,
Public Health ,
Regulatory Reform ,
Toxic Chemicals ,
Trump Administration
The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more
5/23/2025
/ Chemicals ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
FIFRA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Proposed Rules ,
Proposition 65 ,
Public Comment ,
Regulatory Oversight ,
Regulatory Reform ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)