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.