On April 15, 2025, President Donald Trump signed an Executive Order (EO) titled, “Lowering Drug Prices by Once Again Putting Americans First,” building on drug pricing related actions from his first term, President Biden era...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
3/25/2025
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Transparency
On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of Health and Human Services and the White House shortly thereafter issued an Executive Order establishing the Make America Healthy...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
2/13/2025
/ Artificial Intelligence ,
Chevron Deference ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Investment ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Machine Learning ,
Medical Devices ,
Medicare Advantage ,
Popular ,
Prescription Drugs ,
Private Equity ,
Regulatory Agenda ,
Regulatory Reform ,
SCOTUS ,
Technology Sector ,
Trump Administration
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
1/14/2025
/ Draft Guidance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Requirements
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more
1/6/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Over The Counter Drugs (OTC) ,
Pharmacy Benefit Manager (PBM) ,
Policies and Procedures ,
Trump Administration
On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment. As previously discussed here, FDA...more
On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point to promote more efficient and...more
On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat...more
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
In recent days, President-elect Trump has made progress in announcing the names of various individuals he intends to nominate to serve in some of the most senior and influential leadership positions at the Department of...more
Most presidents spend the first days of their administration reversing the policies of their opposite party predecessor and laying the groundwork for their own policies with a series of executive orders. President Trump is...more
11/15/2024
/ Artificial Intelligence ,
China ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Diversity and Inclusion Standards (D&I) ,
Environmental Policies ,
EU ,
Immigration ,
International Emergency Economic Powers Act (IEEPA) ,
Liquid Natural Gas ,
National Security ,
NGOs ,
Policies and Procedures ,
Tariffs ,
Tax Cuts and Jobs Act ,
Trade Act of 1974 ,
US Trade Policies
With a historic election now behind us, the 118th Congress will return to work for a Lame Duck session to address must-pass items and for Senate Democrats to pass as many final judicial appointments as time and political will...more
Congress may be in recess, but that has not slowed down drug pricing policy developments. In recent days, the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO) have rolled out a series...more
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
Key Points - Congress is increasing oversight and legislative activity related to the role of private equity in health care. Sen. Markey and Rep. Jayapal jointly introduced the Health Over Wealth Act on July 25, which aims to...more
8/9/2024
/ Health Care Providers ,
Healthcare ,
Investment ,
Lease Back Transactions ,
No Surprises Act (NSA) ,
Private Equity ,
Proposed Legislation ,
Regulatory Oversight ,
REIT ,
Reporting Requirements ,
Transparency
Senators Ed Markey (D-MA.) and Elizabeth Warren (D-MA.) unveiled “The Corporate Crimes Against Health Care Act of 2024” on June 11, 2024, which seeks to create new civil and criminal penalties for health care investors who...more
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Modernization Act ,
Medicare Part D ,
National Institute of Health (NIH) ,
Orange Book ,
Patents ,
Pharmaceutical Industry
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process