08-19-2025

Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve

Executive OrderView the Original .pdf
View the Original .pdf

The 1-Minute Brief

What: Executive Order 14336 directs the federal government to create a stockpile of the raw ingredients for the nation's most essential medicines. It mandates the creation of a list of approximately 26 "critical drugs" and requires the government to acquire a 6-month supply of their core components, known as Active Pharmaceutical Ingredients (APIs), with a preference for those made in America.

Money: The order does not allocate new funds. Instead, it directs the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) to identify and repurpose existing, available funds to pay for acquiring and storing the APIs. A future cost estimate for a second storage facility is required.

Your Impact: For the average American, there is no immediate, direct effect. The long-term goal is to prevent shortages of critical medicines during a future public health emergency or geopolitical crisis, ensuring drugs remain available when needed most.

Status: Signed and issued by the President on August 13, 2025; currently in the implementation phase by federal agencies.

What's Actually in the Bill

This Executive Order directs the Assistant Secretary for Preparedness and Response (ASPR), a division of HHS, to revitalize and fill the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). The order frames this as a national security imperative, designed to reduce America's dependency on foreign nations for the key ingredients needed to produce essential medicines. It aims to build a domestic buffer stock that can be used to manufacture finished drugs in the United States during a supply chain crisis.

Core Provisions:

  • Within 30 days of the order (by September 12, 2025), the ASPR must identify approximately 26 drugs most critical to the nation's health and security and locate existing funds to pay for the initiative.
  • Within 120 days (by December 11, 2025), the ASPR must prepare the existing SAPIR facility to begin receiving and storing APIs.
  • The ASPR is required to purchase a 6-month supply of the APIs for the critical drugs, prioritizing domestic manufacturers, and stock them in the reserve.
  • Within 90 days (by November 11, 2025), the ASPR must also update a broader list of 86 essential medicines and develop a plan to secure a 6-month supply of their APIs as well.
  • The plan must include a proposal and cost estimate for opening a second SAPIR repository within 1 year.

Stated Purpose (from the Sponsors):

The stated purpose is to protect the health and security of Americans by rebuilding the domestic capacity to produce essential medicines. The order aims to:

  1. Insulate the United States from supply chain disruptions caused by the concentration of API manufacturing in foreign countries, including those considered adversaries.
  2. Encourage and stimulate more domestic production of APIs by creating a reliable government market for them.
  3. Correct the alleged failure of the previous administration to secure the pharmaceutical supply chain, noting that the existing SAPIR is "nearly empty."

Key Facts:

Affected Sectors: Healthcare, Pharmaceuticals, National Security, and Domestic Manufacturing.
Timeline: The order establishes several deadlines for 2025: a 30-day deadline for identifying drugs and funds, a 90-day deadline for a broader supply plan, and a 120-day deadline for preparing the storage site.
Scope: This is a national program focused on the U.S. domestic supply of critical medicines.

The Backstory: How We Got Here

Timeline of Events:

The Rise of Foreign Dependency (1990s-2010s):

For decades, pharmaceutical manufacturing, particularly for the core components (APIs), steadily moved overseas due to lower labor costs and less stringent environmental regulations. This led to a situation where the U.S. became heavily reliant on a few countries, primarily China and India, for the ingredients needed to make many common and critical drugs. The Executive Order notes that only about 10 percent of APIs for drugs used in the U.S. are manufactured domestically.

The First Push for Reshoring (2020):

The COVID-19 pandemic exposed the extreme vulnerability of this global supply chain. In response, Executive Order 13944 was issued on August 6, 2020, to encourage the domestic production of essential medicines and their components. The concept of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) was established during this period to create a national stockpile.

The Post-Pandemic Pause (2021-2024):

According to the text of the new Executive Order, the effort to build this domestic reserve stalled. The order explicitly criticizes the subsequent administration for failing to advance the goal of domestic sourcing, stating that billions were spent on supply chain efforts without increasing domestic production, leaving the SAPIR "nearly empty."

Why Now? The Political Calculus:

  • National Security: There is a growing bipartisan consensus that over-reliance on foreign, and potentially adversarial, nations for critical medical supplies is an unacceptable national security risk.
  • Corrective Action: The order is framed as a direct and immediate response to the perceived inaction of the previous administration, making it a clear policy priority for the current White House.
  • Economic Nationalism: The policy aligns with a broader political sentiment favoring the reshoring of critical industries to create domestic jobs and strengthen U.S. economic independence.

Your Real-World Impact

The Direct Answer: This order primarily affects the pharmaceutical industry and government agencies, with the intended indirect benefit of preventing future drug shortages for all Americans.

What Could Change for You:

Potential Benefits:

  • Fewer Drug Shortages: A domestic API stockpile could prevent or mitigate shortages of essential medicines (e.g., antibiotics, anesthetics, heart medications) during a pandemic, natural disaster, or geopolitical conflict.
  • Stronger Public Health Response: It ensures that the U.S. can manufacture its own critical drugs in an emergency, rather than competing for limited global supplies.
  • Potential Job Growth: Government contracts prioritizing U.S.-made APIs could incentivize companies to build or expand manufacturing plants in the country.

Possible Disruptions or Costs:

Short-term (1-2 Years):

  • Fund Diversion: Because the order uses repurposed funds, money could be shifted away from other public health programs within HHS to pay for the stockpile. The specific impact depends on which programs lose funding.

Long-term:

  • Potential for Higher Drug Costs: If domestically produced APIs are more expensive than foreign ones, and this becomes a long-term sourcing strategy, it could eventually contribute to higher manufacturing costs for certain drugs.

Who's Most Affected:

Primary Groups: U.S.-based pharmaceutical companies (especially API manufacturers), the Department of Health and Human Services, and national security agencies.
Secondary Groups: Hospitals, pharmacies, and patients who depend on the availability of the medicines identified as "critical."
Regional Impact: States or regions that successfully attract new API manufacturing facilities could see economic benefits.

Bottom Line: This order is a government insurance policy; it creates a national stockpile of drug ingredients to ensure the country can make its own essential medicines during a major crisis.

Where the Parties Stand

Republican Position: "America First Healthcare"

Core Stance: The federal government must aggressively pursue policies that end our dangerous reliance on foreign adversaries for essential medicines.

Their Arguments:

  • ✓ Securing the pharmaceutical supply chain is a critical national security issue.
  • ✓ Prioritizing domestic manufacturing will create high-quality American jobs.
  • ✓ A government-held stockpile is a necessary safeguard against future pandemics and global instability.
  • ✗ They would reject arguments that this constitutes undue government interference in the free market, framing it instead as a national security necessity.

Legislative Strategy: As this is an Executive Order from a friendly administration, the strategy will be to support its implementation, defend it against criticism, and work to secure dedicated congressional funding in future budgets to ensure its longevity.

Democratic Position: "Smarter Supply Chain Solutions"

Core Stance: While supply chain resilience is a shared goal, this specific approach may not be the most effective or efficient solution.

Their Arguments:

  • ✓ The goal of reducing dependence on foreign suppliers and preventing drug shortages is important and necessary.
  • ⚠️ Concerns about which HHS programs will lose funding to pay for this initiative and whether there will be sufficient oversight.
  • ⚠️ Questions about whether a government-run stockpile is superior to public-private partnerships or other market-based incentives to encourage domestic production.
  • ✗ They would strongly oppose the partisan claim that the Biden administration "failed" on this issue, likely pointing to their own multi-billion dollar investments in supply chain security and pandemic preparedness.

Legislative Strategy: To use congressional oversight to scrutinize the implementation of the order, particularly the source of the repurposed funds. They may propose alternative legislation focused on different mechanisms, such as tax incentives or direct grants for manufacturers.

Constitutional Check

The Verdict: ✓ Constitutional

Basis of Authority:

The President is acting under their executive authority to direct the operations of federal agencies as granted by the Constitution and federal law. Congress has already granted the Department of Health and Human Services the legal authority to manage public health emergencies and strategic stockpiles (such as the Strategic National Stockpile). This order directs how the executive branch will use that existing authority.

Article II, Section 3 of the U.S. Constitution: "[The President] shall take Care that the Laws be faithfully executed..."

Constitutional Implications:

Executive Power: This is a standard use of an Executive Order to implement a policy goal by directing the actions of an executive branch department (HHS) within the scope of its congressionally delegated powers.
Precedent: The federal government has a long-standing precedent of maintaining strategic stockpiles for national security, including medical supplies, oil, and other critical materials.
Federalism: The order directs federal agencies and does not impose any mandates on state governments, thus presenting no federalism concerns.

Potential Legal Challenges:

Significant legal challenges are unlikely. Any challenges would likely be statutory rather than constitutional, focusing on whether the administration is improperly "repurposing" funds that Congress appropriated for a different, specific purpose. This would likely be a political and oversight battle rather than a court case.

Your Action Options

TO SUPPORT THIS EXECUTIVE ORDER

5-Minute Actions:

  • Contact the White House: Use the White House comment line or website to express your support for Executive Order 14336.
  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121. "I'm a constituent from [Your City/Town], and I support the President's executive order to create a strategic reserve of pharmaceutical ingredients. I urge [Rep./Sen. Name] to support funding for this initiative in the future."

30-Minute Deep Dive:

  • Write a Detailed Email: Contact the House Energy and Commerce Committee and the Senate HELP Committee, which have oversight of HHS, to encourage their support and robust funding for the SAPIR.
  • Join an Organization: Look for advocacy groups focused on domestic manufacturing, national security, or "Made in America" initiatives.

TO OPPOSE THIS EXECUTIVE ORDER

5-Minute Actions:

  • Contact the White House: Use the White House comment line or website to express your concerns about the order, particularly the use of repurposed funds.
  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121. "I'm a constituent from [Your City/Town], and I am concerned about Executive Order 14336. I urge [Rep./Sen. Name] to conduct oversight to see which public health programs are being defunded to pay for it."

30-Minute Deep Dive:

  • Write a Letter to the Editor: Submit a letter to your local newspaper outlining your concerns about the potential costs or the specific approach taken in the order.
  • Join an Organization: Find public health advocacy groups or free-market organizations that may be concerned about the diversion of funds from existing health programs or the level of government intervention in the market.