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 Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and Congress.
Paul uses his Capitol Hill experience in the enactment, amendment and implementation of the Food, Drug, and Cosmetic Act, and such landmark legislation as the Public Health Security and Bioterrorism Act, the Hatch-Waxman Amendments and the Orphan Drug Act to advise clients on regulatory strategies, compliance issues and premarket approvals. He counsels clients on FDA regulatory matters, collaborating with clients to develop comments, petitions, presentations and submissions for agency rulemakings, advisory committee proceedings, early collaboration and pre-submission meetings, and other meetings with key Federal decision-makers. Paul also advises clients on securing funding, facilitating development, and seeking Emergency Use Authorizations (EUA) for COVID-19 diagnostic tests, vaccines, and countermeasures.
Paul also develops effective legislative strategies for industry clients, 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, reauthorization 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 also 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 with the Office of the Commissioner, U.S. Food and Drug Administration, his other public policy experience includes positions with the American Foundation for AIDS Research (amFAR), the largest private funder of HIV/AIDS research and with a major European biopharmaceutical company.
Healthcare
Life Sciences