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An active leader on food and drug law issues, Kate C. Beardsley has more than 30 years of government and private sector experience. She has been recognized by Chambers USA for her work in the area of life sciences since 2007. In 2010, she received the Distinguished Service and Leadership Award from the Food and Drug Law Institute.
Ms. Beardsley represents companies and individuals with interests in biologics, pharmaceuticals, and medical devices. Clients turn to her throughout the U.S. Food and Drug Administration (FDA) regulatory process, whether they are seeking approval, conducting clinical studies, or facing other potential obstacles to market. Corporations in the pharmaceutical and medical industries also rely on Ms. Beardsley’s advice in ensuring compliance with FDA quality systems regulation (QSR) and good manufacturing practices (GMP) obligations, as well as other FDA regulations. She has conducted internal investigations, responded to warning letters, negotiated consent decrees, and defended against government seizures. She also represents clients before the U.S. Consumer Product Safety Commission (CPSC) in matters concerning product recalls and reporting obligations.
She regularly counsels pharmaceutical manufacturers in their efforts to gain or preserve market share, including mounting or fighting exclusivity challenges, and advises companies seeking financing or considering mergers or acquisitions. In addition to her work assisting domestic pharmaceutical and medical device manufacturers through the regulatory process, Ms. Beardsley also counsels international companies preparing to bring products to market in the United States or facing enforcement action.
Ms. Beardsley began her career with a focus on government and consumer interests. She served at the U.S. Office of Management and Budget and later managed a federal interagency council as the deputy director of the U.S. Regulatory Council, where she addressed regulatory issues affecting the FDA, CPSC, U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) and worked on issues such as federal cancer policy. She has consulted on public policy and organization, notably for the U.S. Commission on Wartime Relocation and Internment of Civilians. Prior to practicing law, Ms. Beardsley was a special assistant to Atlanta Mayor Maynard Jackson and a member of the Carter/Mondale transition planning and implementation team.
Prior to joining Zuckerman Spaeder LLP, Ms. Beardsley was a founding partner of Buc & Beardsley, LLP.
Experience
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Conducted an internal investigation regarding alleged off-label marketing practices.
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Represented a client whose product was ultimately approved after the FDA questioned the sufficiency of the clinical trials the client conducted.
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Represented a client in a matter before the CPSC involving a massive recall affecting 3 million units.
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Represented a generic drug manufacturer in a successful challenge to the FDA’s nullification of their generic drug exclusive marketing rights. Represented a medical device manufacturer in successfully reclassifying its product from premarket approval application (PMA) to 510(k) status.
EDUCATION
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Emory University School of Law,
J.D.,
1975, Editor, Emory Law Journal
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Smith College,
B.A.,
1970
COURT ADMISSIONS
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. District Court, District of Columbia
BAR ADMISSIONS
MEMBERSHIPS
- Member, Health and Human Services Secretary’s Advisory Committee on Genetic Testing, 1999-2002
- Editorial Advisory Board, Food and Drug Law Journal, 1998-2003
- Government Affairs Committee, American Association of Tissue Banks, 1996–present (Vice Chair, 1999-2003)
- Lecturer, FDA Center for Devices (medical device law), 2003–2006
- Lecturer, Center for Drugs (biologics and generic drug law), 2007-2009
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PRACTICES
Related Information
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