News & Analysis as of

Food and Drug Administration (FDA) Executive Orders Prescription Drugs

Blank Rome LLP

Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?

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The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more

Carlton Fields

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

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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

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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

Goodwin

Move Fast: FDA is Accepting Submissions for the Pilot Program Class for FDA Commissioner’s National Priority Voucher Program

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FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

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With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

Latham & Watkins LLP

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

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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

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Knobbe Martens

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...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

Carlton Fields

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

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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

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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

McDermott+

President Trump Issues Most Favored Nations Drug Pricing Executive Order

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While much of Washington, DC’s attention this week has been focused on congressional action around budget reconciliation, including proposed changes to the Medicaid program, the White House also made news with release of a...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

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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

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

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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

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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

Akin Gump Strauss Hauer & Feld LLP

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients (Trump EO Tracker)

This order makes it the policy of the United States to have the most-favored-nation price for prescription drugs and biologics. The order directs the Secretary of Commerce and the United States Trade Representative to take...more

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

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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

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

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

Faegre Drinker Biddle & Reath LLP

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Fish & Richardson

Trump’s Drug Price Executive Order: What Drugmakers Should Know

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On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more

Skadden, Arps, Slate, Meagher & Flom LLP

President Trump Issues Executive Order Intended To Lower Drug Prices

On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more

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