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Biosimilars Drug Pricing Department of Health and Human Services (HHS)

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Goodwin

President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs

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In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs.  On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...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

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Venable LLP

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

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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

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

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

Mintz - Health Care Viewpoints

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Goodwin

Recent and Proposed Legislation Affecting Biosimilars

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​​​​​​​Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more

Akin Gump Strauss Hauer & Feld LLP

The Impact of the Inflation Reduction Act of 2022 on Pharmaceutical Innovation, Patent Litigation and Market Entry

Key Points - The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data. New price setting provisions built into the IRA...more

Hogan Lovells

Inflation Reduction Act’s Drug Price Negotiation Program explained

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In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Foley & Lardner LLP

USPTO Underscores Duty of Disclosure Pertaining To FDA Submissions

Foley & Lardner LLP on

The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

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Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Mintz - Health Care Viewpoints

Biden Administration Takes Aim at Rising Drug Prices through its Executive Order on Promoting Competition

On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more

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

Patent Thickets and Regulatory Challenges Cited as Major Factors Limiting Price Reductions in the Biologic Drug Space

The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more

McGuireWoods Consulting

Washington Healthcare Update - March 2020 #1

This week in Washington: Hearings scheduled on the U.S. response to the Coronavirus. ...more

McGuireWoods Consulting

Washington Healthcare Update - February 2020 #4

Upcoming Hearings/Markups - Wednesday, February 26, 2020 - House Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies: “Department of Health and Human Services...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: November 2019

Congressional Developments on Life Science and Consumer Product Issues - Legislation - Citizen Petitions: House Subcommittee Approves Bill to Prevent Overuse - To address the abuse of citizen petitions that delay...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - October 2019

In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. GRASSLEY CONFIRMS DELAY ON DRUG BILL WHILE ANOTHER COMMITTEE PLANS VOTES - Senate Finance Committee Chairman...more

Mintz - Health Care Viewpoints

Five Takeaways from the Senate Finance Committee’s Hearing on Drug Pricing

On February 26, 2019, the Senate Finance Committee heard testimony from top executives representing seven high-profile drug manufacturers. This hearing was the second to examine drug pricing in America. The Committee’s...more

Mintz - Health Care Viewpoints

Significant Drug Pricing Developments in July – Here’s What You Need To Know

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more

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