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  1. Office of Policy, Legislation, and International Affairs

Office of Legislation

Kimberlee Trzeciak, Associate Commissioner for Legislative Affairs

Kimberlee Trzeciak


The Office of Legislation (OL) directs and manages FDA interactions with Congress, ensures that Congress has the most accurate and up-to-date information regarding FDA regulatory actions, coordinates legislative activities with the Department of Health and Human Services, and manages FDA’s response to requests from the various entities that serve Congress (CRS, CBO, and GAO). In addition, OL provides essential information and guidance on relevant Congressional actions to FDA Leadership and advises them in advance of hearings and other key engagements.


  • Advises and assists the Commissioner and other key agency officials concerning legislative needs, pending legislation and oversight activities that affect FDA.
  • Serves as the focal point for overall legislative liaison activities within FDA and between FDA, HHS, and other agencies; and analyzes the legislative needs of FDA and drafts or develops legislative proposals, position papers, and departmental reports on proposed legislation for approval by the Commissioner.
  • Advises and assists Members of Congress and congressional committees and staffs in consultation with the Office of the Secretary on agency actions, policies, and issues related to legislation which may affect FDA.
  • Prepares the FDA Commissioner and other senior FDA officials to testify at Congressional hearings; 
  • Analyzes pending legislation to assess likely impact on FDA; 
  • Monitors and keeps the FDA community informed about key legislative developments that may affect FDA; 
  • Briefs Members of Congress and their staffs on FDA priorities and programs; and
  • Coordinates visits to FDA by Members of Congress and their staffs.

Legislative Chronology


The FDA Reauthorization Act of 2017 (FDARA), signed into law on August 18, 2017, amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.

21st Century Cures Act

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process. Cures enhances our ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs, including:

  • The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products.
  • The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.

In addition, the Cures Act directs FDA to create one or more intercenter institutes to help coordinate  activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products.

Interested in learning more about other legislation? Learn more about the History of FDA’s Fight for Consumer Protection and Public Health

FDA-Affiliated Agencies & Organizations:

FDA Leadership

OL Senior Staff: 

Paul Aguilar, Acting Deputy Director
Phone: 240-402-0383 Email: Paul.Aguilar@fda.hhs.gov 
Uchenna Alexander, Congressional Correspondence Team Supervisor
Phone: 301-796-9125 Email: Uchenna.Alexander@fda.hhs.gov
Shera Moxley, Acting Legislative Director for Devices, Biologics and Tobacco 
Phone: 240-402-1594 Email: Shera.Moxley@fda.hhs.gov
Mahlet Goitom, Acting Legislative Director for Foods and Veterinary Medicine 
Phone: 240-204-4577 Email: Mahlet.Goitom@fda.hhs.gov
Lauren Paulos, Legislative Director for Drugs
Phone: 301-796-3353 Email: Lauren.Paulos@fda.hhs.gov
Sheryl Moats, Management Analyst
Phone: 301-796-5931 Email: Sheryl.Moats@fda.hhs.gov

FDA Organizations:

Contact the Office of Legislation

Phone: 301-796-8900 | Fax: 301-827-8602 | Email: legislation@fda.hhs.gov

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