1800 M STREET, NW
SUITE 1000
WASHINGTON,
DC
20036-5807
202.778.1820
202.822.8106 fax
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William B. Schultz has significant experience in food and drug law. He has championed the interests of generic drug manufacturers and small biotechnology companies, as well as state and local governments and advocacy organizations, in courts, before Congress, and in front of the Food and Drug Administration (FDA). He also represents numerous public interest organizations with food and drug law issues and individuals injured by food or drugs.
As a former deputy assistant attorney general, Mr. Schultz supervised all appellate litigation conducted by the Department of Justice’s Civil Division and the Department’s lawsuit against the tobacco industry, one of the largest lawsuits the U.S. government has ever undertaken. He also served as deputy commissioner for policy at the FDA, where he oversaw the development of FDA policies and regulations, and as counsel to Congressman Henry Waxman, where he helped craft food, drug, and other national health care legislation.
At Public Citizen Litigation Group, where he began his legal career, Mr. Schultz tried and argued cases in federal and state trial and appellate courts, including several cases in the U.S. Supreme Court. Before entering law practice, he clerked for Judge William B. Bryant of the U.S. District Court, District of Columbia. Between 1983 and 1996, he taught civil litigation and food and drug law at Georgetown University Law Center.
His recent successes at Zuckerman Spaeder include representing a client that won a fight to sell generic versions of the nasal spray Flonase and the diabetes drug Precose, as well as acting as counsel to the Campaign for Tobacco Free Kids supporting passage of the Family Smoking Prevention and Tobacco Control Act by the U.S. House of Representatives. The National Law Journal recently named Mr. Schultz as one of the “100 Most Influential Lawyers in America.”
Experience
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Provided expert testimony at hearings on issues related to off-label promotion and cosmetic and drug advertising.
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Advised the New York City Board of Health on preemption case brought to block implementation of its requirement for labeling in restaurants.
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Acted as counsel to a state in efforts to facilitate the importation of prescription drugs from Canada.
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Represented a state in one of the first cases against the makers of OxyContin, helping to secure a large settlement just prior to jury selection.
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Represented a generic manufacturer that obtained a $3 million payment as compensation for lost profits during a temporary restraining order that prevented the FDA from approving the client’s generic version of a popular allergy drug. Zuckerman Spaeder also represented this client when it prevailed in defeating a motion for a preliminary injunction seeking to stop FDA from approving its generic.
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Filed an amicus curiae brief in the U.S. Supreme Court on behalf of Senator Edward M. Kennedy and Congressman Henry A. Waxman regarding preemption of state product liability claims brought in connection with defective medical devices.
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Represented leading public health group in legislation to give the FDA jurisdiction over tobacco products.
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Represented a leading generic manufacturer in negotiations regarding biogeneric legislation.
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Filed an amicus curiae brief in support of the current FDA standards regulating the use of experimental drugs that have not been approved, a position that was upheld in the U.S. Court of Appeals for the District of Columbia Circuit.
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Represented generic manufacturers in navigating the regulatory requirements at FDA.
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Represented generic manufacturers seeking generic exclusivity for a popular diabetes drug, a cholesterol lowering agent, and an epilepsy drug.
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Testified before Congress on pending legislation involving drug safety and drug imports.
EDUCATION
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University of Virginia School of Law,
J.D.,
1974
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Yale University,
B.A.,
1970
COURT ADMISSIONS
- U.S. Supreme Court
- U.S. Court of Appeals, 3rd Circuit
- U.S. Court of Appeals, 4th Circuit
- U.S. Court of Appeals, 6th Circuit
- U.S. Court of Appeals, 9th Circuit
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. District Court, Eastern District of Virginia
- District of Columbia Court of Appeals
- Virginia Supreme Court
BAR ADMISSIONS
- District of Columbia
- Virginia
MEMBERSHIPS
- Chair, Board of Directors, Food and Drug Law Institute
- Board Member, Center for Science in the Public Interest
- Board Member and Treasurer, D.C. Circuit Historical Society
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PRACTICES
Related Information
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