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On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and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/ Draft Guidance ,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On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway.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
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
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
Despite strong private equity interest in drug and device targets, policy changes in the healthcare industry have made the M&A market tricky to navigate. Healthcare has been one of the most active policy focus areas in 2023...more
The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more
3/12/2024
/ Antitrust Provisions ,
Carbon Capture and Sequestration ,
CFIUS ,
China ,
Corporate Transparency Act ,
Divestiture ,
Domestic Dealmaking ,
Drug Pricing ,
Energy Sector ,
Foreign Direct Investment ,
Foreign Investment ,
Greenhouse Gas Emissions ,
Healthcare ,
Investment ,
Life Sciences ,
Liquidity ,
Mergers ,
Non-Compete Agreements ,
Prescription Drugs ,
Private Equity ,
Private Equity Firms ,
Renewable Energy ,
Reporting Requirements ,
UK ,
Unions ,
Venture Capital
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
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
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
8/16/2023
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Generic Drugs ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...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