05-15-2025

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients

Executive OrderView the Original .pdf

The 1-Minute Brief

What: Executive Order 14297, titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," directs federal agencies to take steps to ensure that the U.S. government and its citizens do not pay more for prescription drugs than the lowest price paid by any other comparable developed nation. It aims to end the practice of American consumers subsidizing lower drug costs in other countries.

Money: The executive order does not appropriate specific funds. However, it is intended to generate significant savings for American consumers and federal healthcare programs. For context, the Congressional Budget Office has previously estimated that a similar international reference pricing policy could reduce U.S. drug prices by more than 5 percent. The Inflation Reduction Act's negotiation provisions, a different approach to the same issue, are projected to save taxpayers and enrollees a collective $1.5 billion on just 10 drugs when the first negotiated prices take effect in 2026.

Your Impact: If fully implemented, you could pay significantly less for certain brand-name prescription drugs. The order seeks to align U.S. prices with the lowest prices in other developed countries, potentially reducing costs for some medications by a large margin.

Status: This is an Executive Order, signed on May 12, 2025. It directs various executive branch departments to take action.


What's Actually in the Bill

Executive Order 14297 establishes a new policy for the pricing of pharmaceuticals purchased by or subsidized by the U.S. government. The core principle is to implement a "Most-Favored-Nation" (MFN) model, which would tie what Americans pay for certain drugs to the lowest price paid for the same product in other comparable developed countries. The order argues that Americans should not subsidize global pharmaceutical innovation by paying prices that are often three times higher than in other wealthy nations.

Core Provisions:

  • Most-Favored-Nation Price: The central policy is that Americans should have access to the "most-favored-nation price" for prescription drugs and biologics.
  • Agency Directives: The Secretary of Health and Human Services (HHS), in coordination with other agencies, must communicate MFN price targets to drug manufacturers within 30 days.
  • Enforcement Actions: If manufacturers do not make significant progress towards these targets, the order outlines several potential actions:
    • HHS shall propose a rulemaking plan to impose MFN pricing.
    • HHS shall consider certifying to Congress that allowing drug importation from lower-cost developed nations is safe and will reduce costs.
    • The Attorney General and the Federal Trade Commission shall take enforcement action against anti-competitive practices by drug companies.
    • The Secretary of Commerce will review drug exports that may contribute to price discrimination.
    • The FDA will review and potentially revoke approvals for drugs that are deemed unsafe, ineffective, or improperly marketed.
  • Direct-to-Consumer Sales: The order instructs the HHS Secretary to facilitate programs allowing manufacturers to sell drugs directly to American patients at the MFN price.
  • Trade Policy: The Secretary of Commerce and the U.S. Trade Representative are instructed to take action against foreign countries whose policies suppress drug prices below fair market value, forcing Americans to pay a disproportionate share of R&D costs.

Stated Purpose (from the Sponsors):

The executive order explicitly states its purpose is to end what it calls an "egregious imbalance" where the U.S. population, representing less than 5% of the world, funds about three-quarters of global pharmaceutical profits.

  1. To stop Americans from being forced to subsidize low-cost prescription drugs in other developed countries.
  2. To eliminate the "purposeful scheme" where drug manufacturers offer deep discounts abroad while charging "enormously high prices" in the United States.
  3. To ensure Americans, as the largest purchasers of pharmaceuticals, get the best possible deal and are no longer forced to pay almost three times more for the same medicines.

Key Facts:

Affected Sectors: Healthcare, Pharmaceuticals, Biotechnology, International Trade.
Timeline: The initial directive for HHS to communicate price targets to manufacturers is set for 30 days from the order's issuance on May 12, 2025. Further actions are contingent on the industry's response.
Scope: The order is national in scope but has significant international implications, affecting trade relationships and global pharmaceutical pricing strategies. It aims to impact prices across Medicare, Medicaid, and commercial markets.


The Backstory: How We Got Here

Timeline of Events:

The Era of Unregulated Prices (Pre-2003):

For decades, the U.S. operated with a unique system among developed nations, lacking government regulation for new drug prices. This allowed manufacturers to set their own prices, leading to spending growth that accelerated dramatically in the 1990s with the introduction of "blockbuster drugs" for common conditions.

The Medicare Part D Era (2003-2022):

The Medicare Modernization Act of 2003 created the Part D prescription drug benefit but included a crucial clause: it explicitly prohibited Medicare from negotiating drug prices directly with manufacturers. This was intended to encourage R&D investment but cemented the U.S. as the world's most profitable drug market, with prices far exceeding those in other countries. During this period, brand-name drug prices more than doubled after adjusting for inflation. The high cost of drugs became a persistent, bipartisan public concern.

The Inflation Reduction Act (2022):

After years of debate, the political landscape shifted. The Inflation Reduction Act of 2022 gave Medicare the power to negotiate prices for a limited number of high-cost drugs for the first time in history. The law also required manufacturers to pay rebates to Medicare for price increases that outpaced inflation. This marked a significant departure from previous policy and set the stage for further government action on drug pricing.

Why Now? The Political Calculus:

  • Bipartisan Public Demand: Lowering prescription drug costs is overwhelmingly popular across the political spectrum. Polls consistently show that large majorities of Democrats, Republicans, and independents support government action to regulate drug prices.
  • Revival of a Previous Policy: The "Most-Favored-Nation" concept is not new. A similar policy was attempted during the Trump administration's first term but was blocked by federal courts on procedural grounds and later withdrawn by the Biden administration. This executive order represents a revival and expansion of that effort.
  • Political Pressure: With high drug costs remaining a top concern for voters, there is immense political pressure on leaders to deliver tangible results. This order can be seen as a direct response to that pressure, using executive authority to act where legislative efforts might stall.
  • Economic Frustration: The order's text taps into a deep-seated frustration among Americans who feel they are unfairly bearing the financial burden of global pharmaceutical development while other countries "get a free ride."

Your Real-World Impact

The Direct Answer: This directly affects Americans who take expensive, brand-name prescription drugs, particularly seniors on Medicare.

What Could Change for You:

Potential Benefits:

  • Lower Out-of-Pocket Costs: The most significant potential benefit is a reduction in what you pay at the pharmacy counter for certain high-cost drugs, potentially saving you hundreds or thousands of dollars annually.
  • Increased Price Transparency: The policy could make it easier to see how U.S. drug prices compare globally, fueling more informed public debate.
  • System-Wide Savings: Lower prices for government programs like Medicare and Medicaid could lead to reduced federal spending, potentially resulting in lower premiums or taxes in the long run.

Possible Disruptions or Costs:

Short-term (1-2 years):

  • Access Issues: Some critics worry that manufacturers might delay launching new drugs in the U.S. or limit supply to avoid the lower mandated prices.
  • Market Uncertainty: The pharmaceutical industry could face significant disruption, leading to stock market volatility and potential legal battles that could delay implementation.

Long-term:

  • Reduced Innovation: The primary argument against such price controls is that reducing pharmaceutical company profits will lead to less investment in research and development (R&D), resulting in fewer new cures and treatments being developed in the future. A 2019 study estimated that similar price controls could lead to a 29% to 60% reduction in R&D and 167 to 342 fewer new drug approvals by 2039.
  • Global Price Increases: Manufacturers might respond by pulling out of smaller, less profitable foreign markets to avoid having their U.S. prices tied to those lower rates. This could inadvertently raise the "most-favored-nation" price and reduce drug availability in other countries.

Who's Most Affected:

Primary Groups: Seniors on Medicare, individuals with chronic conditions requiring expensive brand-name drugs, and taxpayers who fund Medicare and Medicaid.
Secondary Groups: Pharmaceutical and biotechnology companies, their employees, and investors. Pharmacy Benefit Managers (PBMs) and health insurers would also see their business models significantly altered.
Regional Impact: The impact would be national, though areas with large senior populations might feel the effects more acutely.

Bottom Line: This executive order could lead to significantly lower prices for your most expensive medications, but it comes with the risk of potentially slowing down the development of new drugs in the future.


Where the Parties Stand

Republican Position: "Promote Competition, Not Price Controls"

Core Stance: Republicans generally favor market-based solutions to lower drug prices, such as increasing competition and price transparency, while opposing direct government price-setting.

Their Arguments:

  • ✓ Support for using trade negotiations to make foreign countries pay more for innovation.
  • ✓ Emphasis on reforming the role of "middlemen" like Pharmacy Benefit Managers (PBMs) who are seen as driving up costs.
  • ⚠️ Concerns that direct price controls will stifle the innovation needed to develop new cures.
  • ✗ Strong opposition to measures seen as "socialized medicine" or government price-setting, which they argue leads to rationing and less access to care.

Legislative Strategy: Focus on legislation to reform PBMs and increase transparency, while arguing that government price negotiation as enacted by the Inflation Reduction Act is a harmful departure from free-market principles.

Democratic Position: "Negotiate for Lower Prices"

Core Stance: Democrats broadly support giving the government the power to directly negotiate drug prices to make medications more affordable for all Americans.

Their Arguments:

  • ✓ Championing the Medicare negotiation powers established in the Inflation Reduction Act as a historic win for consumers.
  • ✓ Support for expanding price caps, like the $35 monthly cap on insulin, to a broader population.
  • ⚠️ Some may express concern that an executive order might not be as durable as legislation passed by Congress.
  • ✗ Opposition to the pharmaceutical industry's argument that lower prices will automatically stifle innovation, pointing out that taxpayers already fund a significant portion of R&D.

Legislative Strategy: Defend and seek to expand the drug price negotiation provisions of the Inflation Reduction Act, while pushing for further measures to cap out-of-pocket costs for more Americans.


Constitutional Check

The Verdict: ⚠️ Questionable

Basis of Authority:

The Executive Order is issued "By the authority vested in me as President by the Constitution and the laws of the United States of America." This is a broad assertion of executive power, likely relying on the President's authority to oversee executive agencies and manage federal programs like Medicare and Medicaid. The order also invokes powers related to foreign trade and commerce.

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

Constitutional Implications:

[Separation of Powers]: A key legal question is whether the executive branch can implement such a sweeping pricing policy without specific legislative authorization from Congress. Critics argue that setting prices for private companies exceeds the President's authority and infringes on Congress's lawmaking power. A similar previous attempt was blocked by courts on procedural grounds.
[Precedent]: While the Inflation Reduction Act established a precedent for government price negotiation, this executive order could be seen as a significant expansion of that power, potentially applying more broadly and with less procedural oversight than the legislative approach.
[Federalism]: This order primarily deals with federal programs and interstate/international commerce, so it is less likely to face challenges based on states' rights.

Potential Legal Challenges:

Legal challenges from the pharmaceutical industry and other stakeholders are highly likely. Lawsuits would likely argue that:

  • The administration has overstepped its executive authority and is effectively making law without Congress.
  • The policy violates the Administrative Procedure Act by failing to go through the proper notice-and-comment rulemaking process. This was the basis for a court blocking a previous version of the policy.
  • The price-setting mechanism could be challenged as an unconstitutional "taking" of private property without just compensation under the Fifth Amendment, an argument also being used against the Inflation Reduction Act.

Your Action Options

TO SUPPORT THIS EXECUTIVE ORDER

5-Minute Actions:

  • Contact the White House: Express your support for Executive Order 14297 through the White House comment line or website.
  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121. "I'm a constituent from [Your City/Town] and I support strong executive and legislative action, like Executive Order 14297, to lower prescription drug prices using a 'most-favored-nation' approach."

30-Minute Deep Dive:

  • Write a Detailed Email: Send a message to the Secretary of Health and Human Services and your congressional representatives detailing your support for the policy's goals.
  • Join an Organization: Groups like AARP have been major advocates for lowering drug prices and support government negotiation.

TO OPPOSE THIS EXECUTIVE ORDER

5-Minute Actions:

  • Contact the White House: Express your opposition to Executive Order 14297.
  • Call Your Rep/Senators: Capitol Switchboard: (202) 224-3121. "I'm a constituent from [Your City/Town] and I urge you to oppose Executive Order 14297. Government price controls will harm innovation and patient access to new medicines."

30-Minute Deep Dive:

  • Write a Letter to the Editor: Submit a letter to your local newspaper arguing that this policy will stifle medical research and ultimately harm patients.
  • Join an Organization: Industry groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) are actively opposing this policy.