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Biden Administration Healthcare Pharmaceutical Industry

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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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

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Axinn, Veltrop & Harkrider LLP

The Fate of the “Last Gasp” of the Biden FTC: Will Its Legacy Survive the Trump Administration?

In the days leading up to President Trump’s inauguration, the Biden FTC rushed to initiate major lawsuits and to tie a bow on various antitrust policy efforts. In a series of dissenting statements, the minority Republican...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Troutman Pepper Locke

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

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The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...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

McDermott+

Regs During an Election Year: What’s on the Menu?

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Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

Fenwick & West LLP

Navigating Healthcare Antitrust in the Biden Era

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It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

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On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Foley Hoag LLP

President Biden Issues Executive Order on Use of Artificial Intelligence in Healthcare Settings

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On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...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

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

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Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

Epstein Becker & Green

The $2 Trillion Build Back Better Act Passes the House, Bringing the Potential for a Significant Health Care Expansion

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On November 19, 2021, the U.S. House of Representatives (“the House”) narrowly passed the Build Back Better Act (H.R. 5376, or “the Act”), a spending bill appropriating nearly $2 trillion for measures to expand the country’s...more

Nelson Mullins Riley & Scarborough LLP

Biden Executive Order Addresses Healthcare Industry Competition, Targets Pharmaceuticals, Pricing, and Hospital Mergers

In an ambitious, far-reaching Executive Order signed on July 9, 2021, President Biden announced a renewed focus by the federal government on the promotion of fair competition amongst American businesses. Specifically, Biden’s...more

Wilson Sonsini Goodrich & Rosati

President Biden Signs Executive Order on Promoting Competition

On July 9, 2021, President Biden signed the Executive Order on Promoting Competition in the American Economy (EO), which states that "excessive market concentration threatens basic economic liberties, democratic...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2021

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more

Brownstein Hyatt Farber Schreck

Analysis of Health Care Provisions Included in Biden Administration FY 2022 Budget Request

Today, Friday May 28, President Joe Biden unveiled his Fiscal Year (FY) 2022 budget request, the first of his presidency. The $6 trillion proposal calls for $1.7 trillion in discretionary spending and $4.0 trillion in...more

Foley Hoag LLP - White Collar Law &...

False Claims Act Enforcement in 2021: A Look Ahead

This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more

Epstein Becker & Green

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

Epstein Becker & Green on

On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

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