News & Analysis as of

Biden Administration Pharmaceutical Industry Healthcare Reform

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

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

Troutman Pepper Locke on

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

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

Foley Hoag LLP on

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

Epstein Becker & Green

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

Epstein Becker & Green on

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

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

White & Case LLP

HHS Report Reiterates Biden Administration Support for Wide-Ranging Action to Address Drug Prices

White & Case LLP on

On September 9, 2021, the Department of Health and Human Services ("HHS") released its widely anticipated "Comprehensive Plan for Addressing High Drug Prices." The HHS report supports far-reaching legislative and...more

Akin Gump Strauss Hauer & Feld LLP

President Biden’s ‘Promoting Competition’ Executive Order: Key Health Care Actions to Follow

As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

Goodwin on

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

BakerHostetler

[Podcast] 32nd Annual Legislative Seminar Series: Senator Bill Cassidy, R-La.

BakerHostetler on

Former Congressman Mike Ferguson, leader of BakerHostetler’s Federal Policy team, and former Congressman Heath Shuler, a Senior Advisor on the Federal Policy team host bipartisan leaders from the House and Senate to discuss...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

Hogan Lovells on

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

ArentFox Schiff

What Should Pharma Companies Expect From the Biden Administration?

ArentFox Schiff on

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

Morgan Lewis

How a Biden Administration Will Affect FDA’s Regulation of Medical Devices

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Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

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