Martha M. Kendrick Partner mkendrick@akingump.com Washington, D.C. T +1 202.887.4215 F +1 202.887.4288 Education J.D., Georgetown University Law Center, 1985 M.A., Bowling Green State University B.A., Newton College of the Sacred Heart Bar Admissions District of Columbia Areas of Experience Coalitions and Associations Food and Drug Law Global Investigations and Compliance Policy and Regulation Privacy, Data Protection and Cybersecurity Public Law and Policy Health Care and Life Sciences Health Care Regulatory Compliance Counseling North America Martie Kendrick helps clients navigate the executive branch to solve regulatory problems involving legislative, regulatory and administrative law for health, education, insurance, municipal and tax issues. Her work often focuses on medical device, biomedical, pharmaceutical, social services, education and human services, and for several years her work has emphasized health and hospital law. She also lobbies in the federal appropriations arena. Practice & Background For more than 25 years, Ms. Kendrick has represented clients before Congress in virtually every major piece of health, Medicare and Medicaid legislation. Her clients consist of large corporations as well as national and state trade associations; state, local and tribal governments; health providers; universities; and pharmaceutical companies. She regularly represents and counsels clients on matters before the Centers for Medicare and Medicaid Services (CMS) relating to Medicare and Medicaid as well as regulatory and funding issues before agencies within the Department of Health and Human Services (HHS), including the National Institutes of Health, the Indian Health Services, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Health Resources and Services
Administration (HRSA). Ms. Kendrick s broad legislative advocacy encompasses congressional authorizing and appropriations committees, including the tax writing Senate Finance and House Ways and Means Committees. She has organized and represented major national coalitions, including the Patient Access to Transplantation Coalition. During her 12 year tenure at the U.S. Department of Health and Human Services, Ms. Kendrick served in a variety of management and policy positions, including organizing and serving as the first acting director of the Carter administration s Office for Families, special assistant to the director (and Social Science Analyst) of the National Center on Child Abuse and Neglect, special assistant to the director of the Office of Health Maintenance Organizations, and legislative analyst concentrating on health issues in the Office of the Secretary. Community Involvement American Health Lawyers Association Founding Board and Steering Committee, Women in Health Policy Former President, Junior League of the City of Washington (1989-90) Founder and Former Chairman, Current Board of Directors, Bright Beginnings, Inc., Co-chair Capital Campaign Board of Directors, Don Bosco Cristo Rey High School Board of Directors, Best Friends Foundation Advisory Board Member, Healthcare Businesswomen s Association - Mid-Atlantic Chapter Member and Leadership Washington Graduate (1989) Founding and Current Member, Council for Women of Boston College Former Board of Directors, The Foundation for America's Blood Centers Founding Board of Trustees of Proliteracy Worldwide, Inc. (formerly Laubach Literacy International) Former Board of Directors and Vice President, The Greater Washington Urban League Former Board Member, Gonzaga College High School Mothers Club Founding Board of Directors, Together for Freedom Sovereign Military Order of Malta (Dame of Malta) Gala Chair, 2013 MedStar National Rehabilitation Network Gala Victory Awards. Awards & Accolades Excellence in Advocacy Award, Veteran Lobbyist Honoree, selected for her impact on health legislation by Bryce Harlow Foundation Judges and awarded at the inaugural Professional Women in Advocacy Conference (2013) Pro Bono Award, Patton Boggs LLP (2013) Georgetown University Law Center 2004 Alumna Award Seniors Coalition Award for Leadership, Legislative Advocacy, and Contributions (2003)
Intercultural Cancer Council Distinguished Service Award (2001) Leadership Washington Volunteer of the Year Award (1996) Junior League of Washington Spirit of Volunteerism Award (1996) Contributions to World Literacy Laubach Literacy Board Recognition (1996-2002). Speaking Engagements Speaker, AAPM&R s 2014 Annual Assembly Washington Update: Year in Review and a Look Ahead (Session 302) November 14, 2014 Speaker, 12 th Annual AMRPA Education Conference, Rehab in Washington: What Congress is doing for - and to - Medical Rehabilitation, September 15, 2014 Speaker, ACG Chicago s 5 th Annual Healthcare M&A Conference, How Do I See What s Coming? Working with Lobbyists and Political Intelligence Firms, June 17, 2014 Speaker, AMRPA Regional Meetings, Rehab in Washington: What Congress is Doing for and to Medical Rehabilitation, June 2014 Periodic Featured Guest, Capital Thinking/Voice America Internet Talk Radio Show Speaker, Princeton Club of New York, The Affordable Care Act: Is this Train on Track?, November 7, 2013 Speaker, The AAPM&R 2013 Annual Assembly, Washington Update: Year in Review and A Look Ahead, October 3, 2013 Speaker, AMRPA Regional Meeting, The Washington 2013 Health Challenge: Avoiding Death by a Thousand Cuts, June 24, 2013 Speaker, 2011 American Academy for Physical and Rehabilitative Medicine Annual Assembly Program, 330. Washington Update: A Look Ahead, November 17, 2011 Speaker, AMRPA 9th Annual Medical Rehabilitation Conference, Post Health Care Reform: Eighteen Months Later The Washington Update, September 26, 2011 Speaker, 2011 MedTech Conference, Updates from the Capitals, September 12, 2011 Speaker, 2011 Legislative Conference American Academy of Pediatrics, Burning Issues, workshop, March 13, 2011 Speaker, AMRPA 7th Annual Medical Rehab Education Conference, October 5, 2009 Keynote Speaker, 13 th Annual Medical Devices Executive MindXchange, March 9, 2008. Articles 2010 "System-Based Practice of Physical Medicine and Rehabilitation" DeLisa's Physical Medicine & Rehabilitation Principles and Practice (pp.485-500), 5th Ed., Volume 1
Nathan A. Brown Partner nabrown@akingump.com Washington, D.C. T +1 202.887.4245 F +1 202.887.4288 Education J.D., Harvard Law School, 1999 B.S., University of Maryland, College Park, 1996 B.A., University of Maryland, College Park, 1995 Bar Admissions District of Columbia Areas of Experience Food and Drug Law Global Investigations and Compliance Policy and Regulation Health Care and Life Sciences Health Care Innovations Health Care Regulatory Compliance Counseling Health Information Technology Health Policy and Legislation North America Nathan A. Brown is a partner in the health care and life sciences practice who focuses on food and drug law, particularly as it relates to medical devices, drugs and biologics. Practice & Background Nathan A. Brown advises health industry participants with regard to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the U.S. Food and Drug Administration (FDA). His practice covers regulatory, compliance and policy advice. Prior to joining the firm, Mr. Brown served in several prominent roles with the FDA. Most recently, he was detailed by the FDA to serve as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee to cover FDA issues. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brown played a lead role negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and coordinating passage of the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) reauthorizations. He advised committee leadership on a broad range of FDA-related legislative and oversight matters, including device, drug and biologics issues, and met with stakeholders across the FDA-regulated industries.
Before going to the Senate, Mr. Brown served in two roles at FDA. As special assistant to the chief counsel, he counseled FDA leadership on high priority and cross-cutting matters, including emerging public health issues, high-profile enforcement cases and congressional investigations. During his time in the Office of the Chief Counsel, he advised FDA s Center for Devices and Radiological Health on a wide range of matters, including device review program reform, guidance development, software and health IT regulation, thirdparty review, laboratory-developed tests and administrative appeals. He served as counsel on the medical device user fee reauthorization (MDUFA III) negotiation team, and represented FDA in providing assistance to Congress on device reform and MDUFA III provisions of the FDA Safety and Innovation Act of 2012 (FDASIA). While at FDA, Mr. Brown also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the Office of Regulatory Affairs (ORA), where he advised the ACRA on compliance, enforcement and policy matters. He represented the ACRA in meetings with industry and in discussions with foreign governments regarding comparability and trade agreements. He also supervised priority matters for ORA, including implementation of FDASIA supply chain and enforcement provisions; coordination with the Office of the Chief Counsel on enforcement matters and litigation; organization of ORA efforts around import policy and implementation of the Food Safety and Modernization Act; and advising the ACRA on enforcement cases and appeals decisions. Prior to his work at FDA, Mr. Brown was a lawyer in private practice, where he focused on providing regulatory, legislative and litigation counsel to national associations, public and non-profit hospitals and other health care providers in a wide range of issues relating to Medicaid, Medicare and other health programs. He represented clients before the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Departmental Appeals Board, various state agencies and in litigation in federal and state courts. He also advised clients on election law and lobbying law requirements. Public Service Member, Montgomery County Board of Social Services (2008-2013) Co-Chair, Maryland Health Benefit Exchange Advisory Committee on Financial Sustainability (2011-2012) Steering Committee Member, Maryland Women s Coalition for Health Reform (2006-2011) Staff Member, Gov. O Malley s Transition Work Group/Maryland Department of Health and Mental Hygiene (2006-2007) Community Involvement In 2001, Mr. Brown served for six months at Bread for the City Legal Clinic, where he handled a variety of Social Security disability appeal cases, family law matters and landlord and tenant cases. Speaking Engagements Speaker, The Price of Reform: Models for Financing a Toxic Substance Control Act 2.0 Policy Roundtable Discussion hosted by Akin Gump, Washington, D.C., February 2015 Speaker, FDA Regulation of Medical Device Software and Mobile Apps: Recent Developments and What to Expect in 2015, hosted by PLI, January 2015
Speaker, Regulatory Guidance for Connected Health Products, MedTech s Connected Care Exchange Conference, November 4, 2014 Speaker, FDA Regulation: Hot Topics, PLI Webast, Health Care and Life Sciences Law 2014 Panelist, FDA Regulation of Mobile Medical Apps, AdvaMed 2014 The MedTech Conference, October 7, 2014 Looking Ahead: A Forum on 503B Compounding, Webinar, October 1, 2014 What Hospitals Need to Know about the New Compounding Law, July 29, 2014. Articles January 20, 2015 January 5, 2015 November 24, 2014 October 17, 2014 August 13, 2014 July 29, 2014 July 3, 2014 "FDA Proposes Additional Flexibility for Mobile Health Products" "Confused About Compounding Regulations? A Brief Primer on FDA Compounding Oversight and Inspection Trends, in Two Charts" American Health Lawyers Association "FDA Issues Three Guidance Documents for Outsourcing Facilities" "IMDRF Releases International Framework for Regulating Device Software" "FDA Takes First Steps Towards Regulating Laboratory Developed Tests" "FDA Accepts First Biosimilar Application under New Approval Pathway" "Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities"