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Course Details

Course Information
  • smart_display Format

    Live Online with Live Q&A

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Tuesday, September 9, 2025

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00

This course is $0 with these passes:

CLE
ALL

This CLE webinar will examine two recently released executive orders (EOs) issued by the new administration related to prescription drug pricing and discuss how these may affect the healthcare industry and who may be most impacted. The panel will discuss the agency objectives outlined in each EO, address agency action to date, and provide best practices for helping healthcare clients navigate this rapidly changing regulatory environment.

Faculty

Theresa C. Carnegie
Member
Mintz

Ms. Carnegie has extensive experience advising clients on all aspects of the pharmaceutical supply chain. Her practice involves advising industry stakeholders on a range of business, legal, transactional, and compliance matters. Ms. Carnegie combines her multilayered industry knowledge with a deep understanding of applicable federal and state legal frameworks, in particular federal and state fraud and abuse laws. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals. Ms. Carnegie is a frequent author and speaker on regulatory and policy issues affecting pharmacy benefits and the pharmaceutical supply chain.

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Tiffanie McDowell
Partner
Crowell & Moring

Ms. McDowell practices in the firm's Antitrust and Competition Group and Health Care Groups. Her practice focuses primarily on complex antitrust litigation, pharmaceutical advertising, pricing and access issues, and health care recovery. Ms. McDowell represents health care and life sciences clients in actions involving patent settlement agreements, product line extensions and alleged product hopping, regulatory approvals and gaming, pharmaceutical pricing and advertising, and market allocation and licensing agreements. She has defended health plans in government investigations, actions involving the 340B program, and actions involving drug access and pricing issues. Ms. McDowell regularly counsels clients on issues related to rebate agreements and formulary access, PBM agreements and the drug supply chain, drug pricing (including under Medicare, Medicaid, and 340B) and access issues, pharmaceutical advertising, and drug overcharge and reimbursement issues.

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Description

The Trump administration recently issued two executive orders aimed at lowering prescriptions drug prices and addressing drug pricing strategies—"Lowering Drug Prices by Once Again Putting Americans First" on Apr. 15, 2025 (April EO) and "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" on May 12, 2025 (May EO). 

The April EO was the first significant action taken by the new administration to address drug prices in various areas, including pricing related to pharmacy benefit managers, Medicare and Medicaid, international importation, and competition in drug manufacturing. The May EO directed federal agencies to implement policies to tie prescription drug prices to international price targets and to facilitate direct to consumer sales at the most favored nation price. While each EO contains broad mandates to agencies, many questions as to how these will be accomplished are left unanswered, creating compliance challenges for those in the healthcare industry. 

Therefore, counsel should understand the EOs' objectives, agency impact and action taken to date to fulfill these objectives, and how healthcare clients may be affected in order to help them navigate this rapidly evolving regulatory landscape.

Listen as our expert panel closely examines the EOs and how they reflect the administration's policy objectives related to prescription drug pricing. The panel will discuss related agency action and address how these may impact the healthcare industry. The panel will also offer best practices for compliance.

Outline

I. Introduction

II. Understanding the executive orders

A. Lowering Drug Prices by Once Again Putting Americans First

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

III. Agency objectives

A. Agency action to date

IV. Potential healthcare industry impact

V. Remaining questions and compliance challenges

VI. Best practices for compliance

Benefits

The panel will review these and other key issues:

  • How are the administration's policies related to prescription drug pricing reflected in each EO?
  • What agencies are impacted by the EOs? What agency action will be required? What agency action has been taken to date?
  • Who in the healthcare industry may be most impacted by the EOs' directives? In what ways?
  • What questions are left unanswered by the EOs? Creating what compliance challenges?