Paul T. Kim

Partner, Co-Chair, FDA Practice - Washington, D.C.

Paul Kim
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Contact Information

202.261.7360

202.467.9615

pkim@foleyhoag.com Download vCard

Regarded as one of the top food and drug lawyers in Washington, Paul Kim draws on his extensive governmental experience to advise clients on legal, legislative and regulatory issues in food, drug and device law, Medicare and Medicaid coverage and reimbursement, and the conduct of clinical research. He represents leading biotechnology, pharmaceutical and medical device companies before the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and Congress.

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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

Representative Experience

  • 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

Honors

  • Best Lawyers in America, FDA Law (2015-2021)
  • 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
  • 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)
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Bar Admissions

  • Maryland
  • District of Columbia