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                Office of Legislation

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          Office of LegislationOffice of Policy, Legislation, and International Affairs Office of Legislation

    
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    Print**Erin O’Quinn Acting, Associate Commissioner for Legislative Affairs**

As Acting Associate Commissioner for Legislation, Erin O'Quinn leads the Office of Legislation (OL). In this role she directs FDA interactions with Congress, advising and providing guidance to FDA Leadership in advance of hearings and other key engagements as well as ensuring that Congress has the most accurate and up-to-date information regarding FDA regulatory actions, managing FDA responses to requests from Congress, and coordinating legislative activities with the Department of Health and Human Services. Prior to joining FDA, Ms. O’Quinn worked for over a decade on Capitol Hill where she served as the Chief of Staff for Congresswoman Kim Schrier, M.D. (D-WA) on the Energy and Commerce Committee, and Deputy Chief of Staff for Congressman Ami Bera, M.D. (D-CA), where she developed long-term strategic agendas and served as the primary advisor on all legislative and policy issues. Earlier in her career she worked as an HIV tester and medical case manager. Ms. O'Quinn received a Master of Public Health and Master of Social Work from the University of North Carolina at Chapel Hill where she focused on Maternal and Child Health and Policy and Management.

Mission

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.

Functions

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

FDARA

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:

United States Department of Health and Human Services

	Assistant Secretary for Legislation
		Assistant Secretary for Financial Resources
		National Institutes of Health
		Centers for Disease Control and Prevention
		Agency for Healthcare Research & Quality
		Substance Abuse and Mental Health Services AdministrationFDA Leadership

OL Senior Staff:

**Uchenna Alexander**, Congressional Correspondence Team Supervisor
Phone: 301-796-9125 Email: Uchenna.Alexander@fda.hhs.gov

**Paul Aguilar**, Legislative Director for Devices, Biologics and Tobacco
Phone: 240-402-1594 Email: Paul.Aguilar@fda.hhs.gov

**Karen Meister**, Acting Legislative Director for Foods and Veterinary Medicine
Phone: 240-204-4577 Email: Karen.Meister@fda.hhs.gov

**Lauren Paulos**, Legislative Director for Drugs
Phone: 301-796-3353 Email: Lauren.Paulos@fda.hhs.gov

**Manasi Raveendran**, Senior Advisor for Oversight
Phone: 301-796-8900 Email: Manasi.Raveendran@fda.hhs.gov

**Sheryl Moats**, Management Analyst
Phone: 301-796-5931 Email: Sheryl.Moats@fda.hhs.gov

FDA Organizations:

Commissioner’s Office
	Center for Biologics Evaluation and Research
	Center for Drug Evaluation and Research
	Center for Devices and Radiological Health
	Center for Food Safety and Applied Nutrition
	Center for Tobacco Products
	Center for Veterinary Medicine
	National Center for Toxicological Research
	Office of Regulatory Affairs**Contact the Office of Legislation**

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

Resources For You

Congressional Testimony
	Laws Enforced by FDA

                                                                                  Content current as of:
      10/05/2023Office of Legislation
 
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