News & Analysis as of

Food and Drug Administration (FDA) Pharmaceutical Industry Trump Administration

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

Holland & Knight LLP on

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

Mintz - Health Care Viewpoints

FDA in Flux — June 2025 Newsletter

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Bradley Arant Boult Cummings LLP

Makary Says Psychedelics Are Maybe Okay, M’Kay?

Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more

McDermott Will & Schulte

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

DLA Piper

Make Our Children Healthy Again Assessment: Unpacking the Report

DLA Piper on

The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key...more

Knobbe Martens

Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

Knobbe Martens on

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans...more

McDermott Will & Schulte

Navigating Political Waves and Policy Shifts - European Health & Life Sciences Symposium 2025

In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available...more

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Goodwin

President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs

Goodwin on

In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs.  On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

DLA Piper

President Trump Signs Executive Order Aimed at Reducing Prescription Drug Prices

DLA Piper on

President Donald Trump signed an Executive Order (EO) titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at reducing prescription drug prices for Americans by ensuring they do not pay...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

Cooley LLP on

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

Goodwin

Most Favored Nation Drug Pricing Executive Order Resurrects Prior President Trump Policy

Goodwin on

On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more

King & Spalding

New Executive Order Promotes Domestic Production of Critical Medicines

King & Spalding on

On May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S....more

DLA Piper

DOJ Memo Identifies False Claims Act and Enforcement Risks Related to Gender Transition Medication and Procedures

DLA Piper on

Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

Carlton Fields on

President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...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

McGuireWoods Consulting

White House Issues Executive Order to Promote Domestic Prescription Drug Manufacturing

On May 5, 2025, President Trump signed an executive order designed to increase U.S. capacity to manufacture drugs domestically. The order instructs the Food and Drug Administration (FDA) to...more

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