Morgan Lewis

Healthcare and FDA Public Policy

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Our Healthcare and FDA Public Policy team assists our clients with monitoring, influencing, and interpreting federal rules and regulations, congressional legislation, and other policies issued by the executive branch.

Many of our attorneys have substantial government backgrounds at healthcare oversight agencies. Decades of experience and extensive government and industry contacts inform and strengthen our representations.

Our experience also enables us to analyze evolving developments rapidly and provide our clients with timely guidance critical to their business.

The Morgan Lewis Healthcare and FDA Public Policy team:

  • Participates in hearings, White House conferences, and strategic planning initiatives before Congress and federal agencies where the principles and guidelines for policies are established. We also assist industry officials in developing core themes and positions.
  • Helps multiple clients with shared interests to unify their positions into a single message to policymakers, often leveraging the support of patient advocacy groups.
  • Advocates directly with members of Congress, Congressional committees and their staffs, regulators, and executive branch officials, including those within the Department of Health and Human Services (including the Food and Drug Administration and the Centers for Medicare and Medicaid Services).
  • Closely tracks legislative and regulatory developments, identifying emerging trends, and interpreting them for clients—allowing companies to anticipate upcoming government policies in time to craft effective advocacy responses and business plans.
  • Assists clients in creating compliance plans, shaping business strategies, and determining the potential competitive advantages of new legislation and regulations.
  • Advises on Medicare and Medicaid coverage and reimbursement policies and requirements.
  • Represents clients before federal agencies, including the Consumer Product Safety Commission and the Federal Trade Commission.
  • Teams with other firm attorneys to provide additional support to clients during congressional oversight investigations.

Our public policy practice is also assisted by a team of scientific specialists, including chemists, toxicologists and engineers with a deep understanding of the scientific process, a capability to identify issues that affect our clients, and the ability to relay pertinent information concisely to our clients. This resource, along with the vast legal resources of our firm as a whole, provides our clients with an unparalleled public policy perspective.