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Government Agencies Regulatory Reform Pharmaceutical Industry

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

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On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Perkins Coie

SAFE Sunscreen Standards Act: Bipartisan Push to Modernize U.S. Sunscreen Regulation

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On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

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On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Smart & Biggar

Updated PMPRB Guidelines expected in summer 2025 and NPDUIS releases ninth edition of the Meds Entry Watch Report

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In the Patented Medicine Prices Review Board (PMPRB)’s June 2025 NEWSletter, Acting Chairperson Anie Perrault confirms that the PMPRB plans on publishing its final Guidelines in summer 2025. This will mark the completion of...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

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The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

Ropes & Gray LLP

Executive Order Calls for Most-Favored-Nation Pharmaceutical Pricing for American Patients

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On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Seeks to Spur Domestic Drug Manufacturing with Regulatory Relief EO

On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

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On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

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As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

Hogan Lovells

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

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Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more

ArentFox Schiff

Mass Layoffs Begin At the FDA

ArentFox Schiff on

As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1....more

A&O Shearman

A new approach to regulation by the MHRA and NICE

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On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

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On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Hogan Lovells

New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 21.02.2025

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Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...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

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