News & Analysis as of

Inflation Reduction Act (IRA) Pharmaceutical Industry Department of Health and Human Services (HHS)

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

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Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Holland & Knight LLP

Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know

Holland & Knight LLP on

President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

Epstein Becker & Green

Medicare Drug Price Negotiation Program: The Inflation Reduction Act “Pill Penalty” and Other IRA Reforms on the Horizon for 2026

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When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

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On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more

Fish & Richardson

Trump’s Drug Price Executive Order: What Drugmakers Should Know

Fish & Richardson on

On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...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

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Goodwin

The Centers for Medicare & Medicaid Services Announces Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation

Goodwin on

As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2024

We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more

Axinn, Veltrop & Harkrider LLP

One Down, Eight to Go: Texas Judge Dismisses Medicare Drug Price Case – Will Others Follow?

A domino has fallen, but the question remains whether there are more to come. On February 12, 2024, the U.S. District Court for the Western District of Texas dismissed a challenge to the Department of Health and Human...more

Goodwin

Court Dismisses PhRMA Lawsuit Challenging IRA

Goodwin on

Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Axinn, Veltrop & Harkrider LLP

The Inflation Reduction Act’s First Potential Impact on Biosimilars

On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

ArentFox Schiff

There’s One for You, Nineteen for Me: IRS Issues Guidance on 1900% Pharmaceutical Excise Tax

ArentFox Schiff on

The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more

Goodwin

Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area...

Goodwin on

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other...more

Venable LLP

First List of Drugs for Medicare Price Negotiations Published Includes Three Biologics

Venable LLP on

The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

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While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more

Goodwin

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act

Goodwin on

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program has now officially kicked off. Earlier today (August 29, 2023), the White House announced the list of the first 10 selected drugs under the program, prior...more

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