News & Analysis as of

Chevron Deference Life Sciences

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Epstein Becker & Green

2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care

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It is critical for health care and life sciences businesses to understand what might and might not change during this transitionary period. How can you advocate for your needs and priorities in a time of such uncertainty? ...more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Ropes & Gray LLP

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

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On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more

Cozen O'Connor

[Event] Health Care & Life Sciences 2025 - December 5th, Philadelphia, PA

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Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses. Join attorneys and professionals from our Health Care &...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark...

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This week, Heather and Matthew welcome their colleagues Mark Moore and Michael Parente, attorneys in Maynard Nexsen’s Government Investigations and White Collar Defense practice. We sit down to discuss their insights on the...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

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FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Ballard Spahr LLP

Life Sciences Industry Update: 2024 Mid-Year Report

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ARTIFICIAL INTELLIGENCE IN LIFE SCIENCES - Life sciences companies are forming AI-driven strategic collaborations with tech giants, creating synergy that promises to revolutionize the industry. Companies like NVIDIA,...more

Fenwick & West LLP

Securities Law Update - August 2024

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Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Foley Hoag LLP

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

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Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Hogan Lovells

Chevron’s demise brings promises & perils for life sciences companies

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The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more

Schwabe, Williamson & Wyatt PC

Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry

“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more

Akin Gump Strauss Hauer & Feld LLP

Chevron Runs Out of Gas: The Bumpy Road Ahead for Health Regulations After Loper Bright

On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more

Morgan Lewis

Life Sciences Post-Chevron: Navigating the Range of Legal and Regulatory Challenges Raised by Loper Bright

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The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more

Foley Hoag LLP

Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies

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Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

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The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...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

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2021

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Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

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For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

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