News & Analysis as of

Federal Funding Drug Pricing

Holland & Knight LLP

Holland & Knight Health Dose: July 29, 2025

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This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...more

Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

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With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more

Sheppard Mullin Richter & Hampton LLP

HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA...more

Jones Day

Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025

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Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

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In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Akin Gump Strauss Hauer & Feld LLP

A New Year, Congress and Trump Administration: 10 Health Issues to Watch in 2025

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

Holland & Knight LLP

Holland & Knight Health Dose: March 12, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Holland & Knight LLP

Holland & Knight Health Dose: December 12, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 39

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Outlook for This Week in the Nation’s Capital - Congress.  Congress is in recess to campaign for the upcoming midterms. Senate Majority Whip Dick Durbin (D-IL) on Wednesday said the Senate will focus on judicial nominations...more

BakerHostetler

Inflation Reduction Act Expected to Become Law

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Key Takeaways: ..The Senate voted 51-50 on August 7 to pass the Inflation Reduction Act. ..The legislation is expected to pass the House this week without changes and to be signed by President Biden. ..The...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

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​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

McCarter & English Blog: Government Contracts...

NIST On Track To Clarify Bayh-Dole To Ensure High Prices Cannot Be Used As Grounds For Exercising March-in Rights – Or Is It?

On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and...more

Baker Donelson

Key Health Care Provisions in New COVID-19 Stimulus Legislation

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On December 21, 2020, the House and Senate passed fiscal year (FY) 2021 federal omnibus appropriations legislation that included the fifth measure passed by Congress to address the COVID-19 pandemic. In addition to providing...more

McDermott Will & Schulte

Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - Health Policy

In this session, health law policy authorities discussed changes likely in 2021 in a Biden Administration and how these changes will impact business objectives and strategies for health industry stakeholders...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

McDermott Will & Schulte

[Webinar] Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - November 5th, 12:00 pm - 2:15 pm EST

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Are you prepared for the critical impacts of the US election outcome to you and your business in 2021 and beyond? Join McDermott’s lawyers and our policy and lobbying team for perspective on the effects of administration...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Baker Donelson

May Deadline for Extending Health Care Programs Looms

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As part of a government spending package enacted in late December, Congress approved government funding through the end of FY20 (September 30, 2020)....more

King & Spalding

Federal Government Funded for Fiscal Year 2020; Surprise Billing and Comprehensive Drug Pricing Legislation Postponed Until 2020

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Last Friday, President Trump signed into law two bipartisan legislative packages that included all twelve Fiscal Year 2020 funding bills. Comprehensive surprise billing and drug pricing legislation were not included in the...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

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – January 2019 #2

It’s now the 24th day of the partial government shutdown and we have yet to see signs of a breakthrough. There doesn’t seem to be much of any negotiating happening at the moment either. Will this be the week where stories of...more

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