Legis
Healthcare
Executive order · Tuesday 15 April 2025

Lowering Drug Prices By Once Again Putting Americans First

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  • The Executive Order aims to restore and enhance efforts to reduce prescription drug prices in the U.S., reversing policies of the Biden Administration.
  • Key accomplishments of the previous administration included:
    • Promoting lower prices for prescription drugs through increased access to generics and biosimilars.
    • Establishing a pathway for the importation of lower-cost drugs.
    • Ensuring government discounts reach patients rather than middlemen.
    • Introducing price transparency rules for patients, doctors, and employers.
    • Capping insulin copayments for Medicare beneficiaries.
    • Proposing innovative payment mechanisms to manage drug prices.
  • The Biden Administration's actions included:
    • The Inflation Reduction Act aimed at addressing Medicare drug prices, but faced criticism for complexity and lower than expected savings.
    • Imposing earlier price controls on small molecule drugs, which is seen as jeopardizing innovation.
  • The Order outlines several directives:
    • Within 60 days, HHS Secretary to propose guidance for the Medicare Drug Price Negotiation Program for the years 2026-2028.
    • Within 180 days, recommendations on stabilizing and reducing Medicare Part D premiums.
    • Modifications to align treatment of small molecule drugs with biological products to prevent distortion of investments.
    • Develop and implement a payment model to achieve better value for high-cost drugs.
    • Conduct a survey of hospital acquisition costs for outpatient drugs to align Medicare payments with those costs.
    • Ensure manufacturers provide accurate Medicaid drug rebates and promote innovation in payment methodologies.
    • Grants for health centers to make insulin and injectable epinephrine available at discounted prices for low-income individuals.
    • Recommendations to promote a competitive and efficient pharmaceutical value chain.
    • Recommendations to accelerate approvals for generics and improve the over-the-counter classification process for certain drugs.
    • Streamline importation processes for States to obtain approval without sacrificing safety.
    • Evaluate regulations to prevent cost shifts from physician offices to hospital outpatient settings.
    • Propose regulations to improve employer transparency regarding pharmacy benefit managers.
    • Conduct public listening sessions to recommend measures reducing anti-competitive behavior in the pharmaceutical industry.
  • The order reaffirms the authority of executive agencies and is subject to applicable laws and appropriations.