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  1. Office of Policy, Legislation, and International Affairs

Office of Legislation


Karas Gross, Associate Commissioner for Legislative Affairs

Mission

The Office of Legislation (OL) ensures that Congress has the most accurate and up-to-date information about biomedical research, 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, advice, and guidance on FDA-relevant Congressional actions to the FDA Commissioner, FDA’s Executive Leadership, and the FDA’s Centers. 

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:

FDA Leadership

OL Senior Staff: 

Karas Gross, Associate Commissioner for Legislation
Phone: 301-796-8378 Email: Karas.Gross@fda.hh.gov
Executive Assistant:  Isabel Sobel
Phone: 301-796-4652 Email: Isabel.Sobel@fda.hhs.gov
  
Andrew Tantillo, Deputy Director
Phone: 301-796-8919 Email: Andrew.Tantillo@fda.hhs.gov
 
Karen Meister, Senior Advisor
Phone: 301-796-8916 Email: Karen.Meister@fda.hhs.gov
 
Jonathan Hodnette, Senior Advisor for Oversight
Phone: 301-796-8901 Email: Jonathan.Hodnette@fda.hhs.gov
 
Uchenna Alexander, Congressional Correspondence Team Supervisor
Phone: 301-796-9125 Email: Uchenna.Alexander@fda.hhs.gov
 
Paul Aguilar, CDRH/CBER/CTP Acting Team Supervisor
Phone: 240-402-0383 Email: Paul.Aguilar@fda.hhs.gov
 
Tristan Colonius, CFSAN/CVM/NCTR Team Supervisor
Phone: 301-796-2624 Email: Tristan.Colonius@fda.hhs.gov
 
Jodi Schipper, CDER Team Supervisor
Phone: 301-796-3353 Email: Jodi.Schipper@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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