|
Paul T. Kim
Partner
Boston
Regarded as one of the top food and drug lawyers and life science lobbyists 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.
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 compliance issues and regulatory approvals. He also assists with general FDA regulatory matters, collaborating with clients to develop comments, petitions, presentations and regulatory submissions for agency rulemakings, advisory committee proceedings, early collaboration and pre-submission meetings, and other meetings with key Federal decision-makers. Clinical research compliance, FDA product approval, CMS coverage and reimbursement issues, and bioresearch monitoring are additional areas of focus in Paul's regulatory practice.
Federal legislative advocacy is another primary focus of Paul's client counsel. He develops effective legislative and media strategies for industry clients, manages advocacy coalitions, and helps clients develop constructive relationships with key federal regulators and congressional decision-makers. He also represents clients before congressional committees and with in their dealings with individual members of the United States Senate and the House of Representatives, defends their interests in congressional oversight and investigations, and helps them prepare for hearings.
Before joining Foley Hoag Paul was Deputy Staff Director for health policy for Senator Edward M. Kennedy, who chairs 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 of 2001 (whose food safety protections were deemed "the most significant expansion of federal authority over the food industry in more than six decades" by the New York Times), the Reauthorization of the Prescription Drug User Fee Act, The Medical Device User Fee and Modernization Act of 2002, The Rare Diseases Act of 2002 (amending the Orphan Drug Act), The Best Pharmaceuticals for Children Act, and Senate passage of the Greater Access to Affordable Pharmaceuticals Act of 2001.
Paul also was Counsel to Congressman Henry A. Waxman (serving as staff in both the House of Representatives and the Senate, as well as in conference, on the Food and Drug Administration Modernization Act of 1997) and as a professional staff member to Senator David Pryor on the U.S. Senate Special Committee on Aging and the U.S. Senate Finance Committee. His other public policy experience includes positions as Assistant Director for Government Relations with the American Foundation for AIDS Research (amFAR), the largest private funder of HIV/AIDS research, as a Policy Analyst with the Office of the Commissioner, Food and Drug Administration, and with Ciba-Geigy Pharmaceuticals in Basle, Switzerland.
Bars and Court Admissions
Maryland
District of Columbia
Representative Experience
The following is a brief summary of Paul's experience and accomplishments:
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
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
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.
| 