Sheila D. Walcoff is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. In 2008, Sheila was appointed to the U.S. Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). In addition, Sheila was appointed to the MIT Council for Biomedical Innovation (CBI) Strategy and Policy Council and was elected to the Board of the Friends of the National Zoo (FONZ) in 2009.
A recognized health policy expert, Sheila focuses her practice on personalized medicine and other federal regulatory and science policy matters. She counsels a broad range of clients, including pharmaceutical and biotechnology companies; specialized laboratories; science and technology start-ups; and associations/coalitions on policy, government affairs advocacy, business strategy and communications.
Her specific experience includes:
- Developing and managing major national public/private strategic initiatives, including accelerating personalized health care/genomics and information technology and promoting prevention and wellness
- Counseling clients on the application and intersection of FDA/CMS regulatory authority and the Clinical Laboratory Improvements Act (CLIA)
- Counseling clients on regulatory issues and policies related to follow-on biologics, bioequivalence to branded pharmaceutical products, risk evaluation and mitigation strategies and product nomenclature
- Developing and implementing comprehensive lobbying strategies, including areas of health reform
- Expanding client participation in Washington-based coalitions, developing strategic partnerships for clients, and promoting client prominence among policymakers and industry leaders
- Working with senior career and political officials at HHS and the White House, including FDA, NIH, CDC, AHRQ, CMS, HHS Office of General Counsel and HHS Office of Policy and Planning on matters related to molecular diagnostics, biopharmaceuticals, personalized medicine, co-development/companion diagnostics and comparative effectiveness research
- Coordinating senior-level federal government rapid-response teams to develop federal health policy programs
- Managing crisis communications
Sheila has significant federal health policy, communications, legislative/regulatory and management experience. She served as counselor to the secretary of the U.S. Department of Health and Human Services (HHS). As counselor, Sheila advised the HHS secretary, the White House and other government agencies on all science and public health policy, management, communications and budget matters, including personalized medicine, follow-on biologics, amendments to the Food Drug and Cosmetic Act and food safety. She served the administration as the principal policy liaison managing the four public health and science operating divisions of HHS: the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and Agency for Healthcare Research and Quality (AHRQ). She also developed and directed major HHS and administration initiatives, including personalized health care, genomics and information technology, prevention, World Trade Center responder health care and HIV/AIDS initiatives.
Prior to her appointment to counselor, Sheila served as associate commissioner for external relations at FDA, where she provided policy and communications counsel to the FDA commissioner and other senior government officials, managed the Offices of External Relations and Public Affairs, directed the agency's interactions with its stakeholders and managed the Agency’s response to a number of critical, high profile product safety issues.
From 1999 to 2004, Sheila was an attorney with a large international law firm, where she provided legal and strategic legislative/regulatory counsel to large business entities and other organizations on a wide variety of health policy, information technology and other business issues.
Sheila also has significant government strategies and legislative experience, having served as the majority counsel to the U.S. House of Representatives Armed Services Committee.
After leaving her post as a senior advisor to the secretary of HHS, Sheila served as the health policy team leader/senior health policy advisor to Fred Thompson’s 2008 presidential campaign.
Sheila earned her J.D. in 1993 from the Georgetown University Law Center and is affiliated with The Federalist Society for Law & Policy, the American Health Lawyers Association, the American Bar Association and the American Veterinary Medical Law Association.
Sheila is admitted to practice in Maryland and the District of Columbia.
Education
- Georgetown University Law Center, J.D., 1993
- Minot State University, B.A. (cum laude), 1990
