Kim

Paul T. Kim

Partner
Co-Chair, Federal Government Strategies & FDA Practices
Washington, DC

My Capitol Hill experience enacting major health legislation gives clients the insights to achieve their policy & regulatory goals.

Paul Kim draws on his extensive Federal governmental experience to advise clients on legal, legislative and regulatory issues in food, drug and device law, Medicare and Medicaid coverage and reimbursement, countermeasure development for biodefense and against emerging infectious diseases, and the conduct of clinical research. He represents leading biotechnology, pharmaceutical, diagnostic, and medical device companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS) and Congress.

Paul uses his Capitol Hill and legal experience in the design, enactment and implementation of amendments to the Food, Drug, and Cosmetic Act and the Public Health Service Act, and such landmark legislation as the Public Health Security and Bioterrorism Act, the Hatch-Waxman Amendments and the Orphan Drug Act. He advises life science clients on FDA regulatory strategies, compliance issues and premarket approvals for emerging technologies such as gene editing, gene therapy, and biosimilars, collaborating with them to develop comments, petitions, presentations and submissions for agency rulemakings, advisory committee proceedings, early collaboration and pre-submission meetings, and other engagements with key Federal decision-makers. Paul also advises clients on securing funding and facilitating development of CBRN countermeasures, as well as seeking Emergency Use Authorizations (EUA) for COVID-19 diagnostic tests and vaccines.

Paul develops comprehensive legislative and advocacy strategies, manages advocacy coalitions, and helps clients develop constructive relationships with key federal regulators and congressional decision-makers. He represents clients before Congress, including preparation of testimony and representation in congressional oversight and investigations.

Before joining Foley Hoag, Paul was Senator Edward M. Kennedy’s Deputy Staff Director for health policy on the U.S. Senate Health, Education, Labor and Pensions Committee. Major laws enacted while Paul served with Senator Kennedy include the Public Health Security and Bioterrorism Response Act, reauthorizations of the Prescription Drug User Fee Act, the Medical Device User Fee and Modernization Act, the Rare Diseases Act amending the Orphan Drug Act, the Best Pharmaceuticals for Children Act, and Senate passage of the Greater Access to Affordable Pharmaceuticals Act.

Paul was Counsel to Congressman Henry A. Waxman on FDA and public health issues during his leadership of the House Energy and Commerce Committee, and to Senator David Pryor on the U.S. Senate Special Committee on Aging and the U.S. Senate Finance Committee. In addition to Paul’s time with the Office of the Commissioner, U.S. FDA, he has worked on public policy with the American Foundation for AIDS Research (amFAR), the largest private funder of HIV/AIDS research, and a global biopharmaceutical company. 

Education

  • Georgetown University Law Center, J.D., 1998
  • Harvard University John F. Kennedy School of Government, M.P.P., 1990
  • Harvard College, A.B., cum laude, 1988

Bar and Court Admissions

BAR ADMISSIONS
  • Maryland
  • District of Columbia

Experience Overview

  • Coordinating product approval, coverage and reimbursement - Advises clients on managing and coordinating the timely development of clinical and pharmacoeconomic data for both FDA product approval and CMS coverage and reimbursement.
  • Clinical research compliance and bioresearch monitoring - Assists in achieving compliance with FDA and Common Rule requirements for human research subject protections, including guidance on legislative initiatives and the new Federalwide Assurance of Protection for Human Subjects (FWA), and legal support in response to oversight by the FDA and the HHS Office for Human Research Protections (OHRP).
  • Premarket applications - Assists in preparing and reviewing fast track and accelerated approval applications, as well as other innovative NDAs, PMAs and supplements undergoing priority review at FDA
  • Device reforms, reprocessed devices and combination products - Aids medical device clients in working with the Office of Combination Products, and provides guidance on implementation of policies on reprocessed devices and qualification for and use of the CDRH third-party device review and inspection programs.
  • Hatch-Waxman Act - Provides advice on the latest developments affecting product approvals and market exclusivities, including generic biologics, FDA and court decisions, FTC investigations and legislative activity.
  • Orphan Drug Act - Counsels clients on FDA and CMS policies affecting orphan product approval and reimbursement, helps secure orphan designations, market exclusivities and tax credits, as well as humanitarian device exemptions.
  • Biodefense and bioterrorism - Advises biotechnology and medical device clients on post-September 11 laws and funding programs promoting the development of biodefense countermeasures; provides guidance on the proper implementation of new food safety and select agent regulations under the Public, Health, Security and Bioterrorism Preparedness and Response Act.

Foley Hoag Publications

Honors & Involvement Overview

HONORS 
  • Best Lawyers in America, FDA Law (2015-2023)
  • Washington DC Super Lawyer for Food and Drug Law, Government Relations (2010, 2014 and 2015)
  • Named one of the top Food and Drug lawyers in the Washington, DC annual review of attorneys by WASHINGTONIAN magazine (2009, 2007 and 2004)
  • Commissioner of Food and Drug Special Citation
  • Sloan Foundation Fellow

Speaking Engagements Overview

  • A Hatch-Waxman Review: What to Know About the Hatch-Waxman Act As It Turns 39+, Foley Hoag Webinar (October 2022)
  • How to Navigate a Congressional Investigation, Foley Hoag Webinar (July 2021) 
  • Precision Medicine and the FDA: Prospects for Regulation of Laboratory Developed Tests, BIO International Convention (June 2019)
  • Innovation and the U.S. FDA, Korean Innovative Medicine Salon (September 2019)