News & Analysis as of

Government Agencies Drug Pricing Pharmaceutical Industry

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Smart & Biggar

Updated PMPRB Guidelines expected in summer 2025 and NPDUIS releases ninth edition of the Meds Entry Watch Report

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In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more

McDermott Will & Schulte

This Week in 340B: June 10 – 16, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Cozen O'Connor

New Mexico Joins Growing List of States to Secure Insulin Price Cap Settlements

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New Mexico AG Raúl Torrez announced settlementswith Sanofi-Aventis U.S. LLC and Novo Nordisk Inc. to resolve allegations that the pharmaceutical companies’ pricing policies resulted in underinsured and uninsured patients...more

Brownstein Hyatt Farber Schreck

Most-Favored-Nation Drug Pricing in the U.S.

On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

Sheppard Mullin Richter & Hampton LLP

Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more

Goodwin

State Drug Transparency Laws - 2025 Update

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We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book

In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more

McDermott Will & Schulte

Navigating Political Waves and Policy Shifts - European Health & Life Sciences Symposium 2025

In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available...more

McDermott Will & Schulte

This Week in 340B: May 13 – 19, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Ropes & Gray LLP

Executive Order Calls for Most-Favored-Nation Pharmaceutical Pricing for American Patients

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On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Continues Focus on Drug Pricing with “Most-Favored-Nation Prescription Drug Pricing” Executive Order

On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more

McDermott Will & Schulte

This Week in 340B: May 6 – 12, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more

ArentFox Schiff

District Court Dismisses Manufacturer Lawsuit Challenging Colorado Price Setting for Prescription Drug

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There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Goodwin

Health Headlines: April 2025

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Welcome to the fifth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

McDermott Will & Schulte

This Week in 340B: April 15 – 21, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Latham & Watkins LLP

Healthcare & Life Sciences Drug Pricing Digest - April 2025

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The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Stikeman Elliott LLP

British Columbia and Prince Edward Island Sign Pharmacare Agreement with Canada Under New Pharmacare Act

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On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

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As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2019

Congress returns to D.C. this week for a short three-week sprint to a series of important deadlines on September 30. Chief among them is funding the federal government for Fiscal Year (FY) 2020 which begins on October 1,...more

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