News & Analysis as of

Manufacturers Executive Orders Pharmaceutical Industry

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Mintz - Health Care Viewpoints

Trump Sends Letters to Manufacturers Regarding Most-Favored-Nation Executive Order Requirements

In follow-up to the May 12th “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” Executive Order, President Trump issued letters to seventeen manufacturers (Letters), reiterating the mandate for...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

Latham & Watkins LLP on

Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Continues Focus on Drug Pricing with “Most-Favored-Nation Prescription Drug Pricing” Executive Order

On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more

Mintz

Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain

Mintz on

After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...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

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

Morgan Lewis on

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...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

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

McDermott Will & Schulte

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

Foley & Lardner LLP on

Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

King & Spalding

Biden Administration Releases Industrial Base Reports

King & Spalding on

Reports identify weaknesses and introduce plans to strengthen certain critical supply chains - On February 24, 2022, the Biden Administration released a Plan to Revitalize American Manufacturing and Secure Critical Supply...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

Alston & Bird on

In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Womble Bond Dickinson

Opportunity Economy: Risks in Antitrust Enforcement

Womble Bond Dickinson on

Takeaways - ..The Biden administration’s recent executive order takes a hard line on limits to employment mobility, such as non-compete agreements. ..No-poach agreements—companies agreeing not to recruit each other’s...more

Foley & Lardner LLP

President Biden’s Executive Order on Competition Could Mean Broad Changes Across a Range of Industries

Foley & Lardner LLP on

On Friday, July 9, 2021, President Biden issued a sweeping Executive Order that could have far-reaching implications for businesses across a broad spectrum of industries. The Executive Order takes a government-wide approach...more

Husch Blackwell LLP

White House Issues Final Report On Supply Chain Risks And Considers Section 232 Investigation Into Imports Of Neodymium Magnets

Husch Blackwell LLP on

President Biden issued Executive Order (“EO”) 14017 titled “America’s Supply Chains” on February 24, 2021, ordering 100-day and 1-year reviews of certain critical supply chains. On June 8, 2021, a final report was published,...more

Holland & Knight LLP

Biden Administration Report Outlines Strategy to Invigorate Domestic Supply Chains

Holland & Knight LLP on

The Biden Administration on June 8, 20201, released findings from a 100-day interagency domestic supply chain assessment of critical products and outlined a series of steps it will take in order to strengthen U.S. critical...more

Hogan Lovells

Biden Administration Releases First 100-Day Review, Spurring Immediate Actions for US Supply Chains

Hogan Lovells on

Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for semiconductor manufacturing and advanced packaging,...more

WilmerHale

Biden Administration Announces Steps to Strengthen Critical Supply Chains

WilmerHale on

On June 8, the Biden Administration released reports on the supply chain reviews directed under Executive Order (E.O.) 14017, “America’s Supply Chains,” detailing key findings and next steps to strengthen the resilience of...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

32 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide