1800 M Street, N.W., Washington, D.C. 20008 • (202) 778-1820 (o) • wschultz@zuckerman.com
Zuckerman Spaeder LLP, Washington, D.C.
Represents healthcare providers, small biotech companies, generic drug companies, individuals and public interest organizations before the Department of Health and Human Services, the Food and Drug Administration, other federal agencies, and in court.
Department of Health and Human Services, Washington, D.C.
General Counsel
(Acting General Counsel, March 2011- April 2013)
Responsible for legal representation and advice to the Secretary and other senior leaders of the Department of Health and Human Services regarding programs that spend $1 trillion a year, including Medicare, Medicaid, the Affordable Care Act, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control. Worked closely with Solicitor General and other Justice Department officials on numerous landmark cases, including four Supreme Court challenges to the Affordable Care Act. Managed office of 500 attorneys which was responsible for all HHS litigation, and for reviewing all HHS regulations and significant policies.
Zuckerman Spaeder LLP, Washington, D.C. 2001-2011
U.S. Department of Justice
Deputy Assistant Attorney General, Civil Division
Responsible for overseeing all Civil Division appellate litigation and the Department’s Tobacco Litigation Team. Supervised 80 attorneys and argued six significant cases in U.S. Circuit Courts of Appeals.
U.S. Food and Drug Administration
Deputy Commissioner for Policy
Principal advisor to the Commissioner on all significant policy issues and responsible for development and management of all regulations. Deputy with principal responsibility for FDA’s tobacco initiative, food safety initiative, and legislative issues before Congress. Served as Acting Commissioner on numerous occasions.
U.S. House of Representatives, Committee on Energy & Commerce, Subcommittee on Health and the Environment (Rep. Henry A. Waxman, Chairman)
Lead counsel responsible for drafting and negotiating Nutrition Labeling and Education Act of 1990, Medical Device Amendments of 1990, and Prescription Drug User Fee Act of 1992. Also worked on health care, trade and tobacco legislation.
William B. Schultz
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Public Citizen Litigation Group, Washington D.C.
Represented public interest and public health organizations in courts, agencies, and Congress. Litigated law reform cases on administrative procedure, state and federal constitutional law, antitrust, voting rights, product liability, nuclear power, and food and drug law. Argued three cases in the U.S. Supreme Court and over 20 cases in U.S. Circuit Courts of Appeals.
Georgetown University Law Center, Washington, D.C.
1983-1993, 1996
Adjunct Professor
Food and Drug Law, 1988-1993, 1996
Civil Litigation, 1983-1987
U.S. District Court, Washington, D.C.
Law Clerk, Judge William B. Bryant
University of Virginia School of Law, J.D., 1974
Yale University, B.A. in Economics, 1970
SELECTED CASES (Principal Attorney)
Michigan Citizens for an Independent Press v. DOJ, 493 U.S. 38 (1989) (challenge to antitrust exemption invoked to allow merger of The Detroit News and The Detroit Free Press; merger affirmed by equally divided court).
Young v. CNI, 476 U.S. 974 (1986), 808 F.2d 943 (FDA statutory argument rejected by Supreme Court but on remand D.C. Circuit, in frequently cited opinion, accepted APA procedural argument to invalidate FDA action levels that had permitted contaminants such as mercury in foods without public process).
Duke Power Co. v. Carolina Environmental Study Group, 438 U.S. 59 (1978) (constitutional challenge to limits on liability for nuclear power plants; Supreme Court accepted standing in precedential decision, but ruled in favor of Duke Power on one constitutional issue and found the case was not ripe to decide a second constitutional issue).
In Re: Executive Office of the President, 215 F.3d 25 (D.C. Cir. 2000) (rejected mandamus petition contesting discovery of counsel to the President).
Campbell v. Clinton, 263 F.3d 19 (D.C. Cir. 2000) (prevailed in urging court to reject challenge by members of Congress to war in Kosovo as violation of War Powers Act).
William B. Schultz
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Washington Legal Foundation v. Henney, 202 F.3d 331 (2000) (prevailed in urging court not to decide First Amendment challenge to FDA regulation of claims about unapproved uses of drugs).
Comsat Corp. v. National Science Foundation, 190 F.3d 269 (4th Cir. 1999) (prevailed in urging court to reject third party subpoenas to federal agency).
Wolfe v. Department of Health and Human Services, 839 F.2d 768 (D.C. Cir. 1988) (en banc) (Freedom of Information Act case to obtain logs of status of pending regulations; challenge rejected by a closely divided court).
Public Citizen v. Young, 831 F.2d 1108 (D.C. Cir. 1987) (prevailed in urging court to reject FDA’s policy of approving cancer-causing color additives as violation of law).
Cutler v. Hayes, 818 F.2d 879 (D.C. Cir. 1987) (prevailed in series of lawsuits that forced the FDA to regulate over-the-counter drugs for safety and effectiveness).
Public Citizen v. Steed, 733 F.2d 93 (D.C. Cir. 1984) (prevailed in challenge to Reagan Administration’s suspension of the tire rating program).
Morrison v. Nissan Motor Co., 601 F.2d 139 (4th Cir. 1979) (court rejected antitrust challenge to price fixing by automobile repair shops).
American Hospital Association v. Azar, 348 F.Supp.3d 62 (D.D.C. 2018) ($1.8 billion in annual cuts to reimbursements for hospitals illegal)
Department of Insurance v. Dade County Consumer Advocate’s Office, 492 So.2d 1032 (S. Ct. Fla. 1986) (prevailed in case ruling that Florida law prohibiting insurance rebating violated Florida constitution).
Convention Center Referendum Committee v. Board of Elections and Ethics, 441 A. 2d 889 (D.C. Ct. App. 1981) (en banc) (first case defining the right of legislative initiative in the District of Columbia; closely divided court rejected argument that initiative at issue was invalid).
Mink v. University of Chicago, 460 F. Supp. 713 (N.D. Ill. 1978) (Congresswoman Patsy Mink’s successful challenge to university drug experiment in the early 1950’s).
Leadership Council, Yale School of Public Health (2017-Present)
Member, Committee on Science, Technology & Law, National Academy of Sciences (2017-Present)
Board of Directors, National Health Law Program
Board of Trustees, Partners in Health
Member, Administrative Conference (1989, 2011-2016)
Chairman, Food and Drug Law Institute (2008-2009)
Board of Directors and President, Center for Science in the Public Interest (2005-2011, 2019-Present)
Member and Treasurer, Board of Directors, D.C. Circuit Historical Society (2004-2011, 2017-Present)
William B. Schultz
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Board of Directors, The Keystone Center (2003-2006)
Committee on Shortening the Timeline for New Cancer Treatments,
Institute of Medicine (2002-2005)
Judicial Conference of the D.C. Circuit (1980-92, 2000, 2002-03, 2006-08)
Editorial Advisory Board, Food, Drug, Cosmetic Law Journal (Chairman, 1989)
Scheuer-Gore Commission on the Drug Approval Process (1982)