William B. Schultz_bio
Download this bio as .pdf
ZS_FDA-Generics_thumbnail

Food and Drug Practice Brochure

Download .pdf

William B. Schultz

Partner

Office
Washington, DC
Tel.
+1 202.778.1820
Fax.
202.822.8106
Others
Send an Email
vCard
LinkedIn

William B. Schultz focuses on complex regulatory issues and provides strategic advice to companies and public interest organizations. He represents providers and consumers before the U.S. Department of Health and Human Services (where he served as general counsel), other federal agencies, and the courts. 

Bill also assists generic drug companies, nonprofit organizations and other clients before the Food and Drug Administration, where he served as Deputy Commissioner for Policy.

As general counsel at HHS from 2011 to 2016, Bill served as counsel to two HHS secretaries on all legal matters and managed an office of 500 lawyers across eight offices, covering 10 regions across the country. HHS administers $1 trillion per year in federal programs, including Medicare, Medicaid, the Affordable Care Act, the FDA, the National Institutes of Health, and the Centers for Disease Control. The office of general counsel is responsible for all litigation where HHS is a party, ensuring regulations and policy decisions are consistent with the law, reviewing legal issues involving appropriations, and ensuring ethical rules are followed.

Prior to joining HHS, Bill was a partner at Zuckerman Spaeder and represented nonprofit organizations, state and local governments, individuals, generic drug companies and small biotechnology companies.

From 1999 to 2000, Bill was deputy assistant attorney general at the U.S. Department of Justice, where he was responsible for overseeing all civil division appellate litigation and the department’s tobacco litigation team.

From 1994 to 1999, Bill was deputy commissioner for policy for the FDA, where he was the principal advisor to the Commissioner on all significant policy issues and was responsible for development and management of all regulations.

From 1989 to 1994, Bill was the counsel to the Subcommittee on Health and the Environment (Rep. Henry A. Waxman, chairman), Committee on Energy and Commerce, U.S. House of Representatives, where he worked on health care, FDA, tobacco and trade legislation.

From 1976 to 1989, Bill was an attorney with the Public Citizen Litigation Group, where he litigated law reform cases on state and federal constitutional law, antitrust and administrative law, voting rights, product liability, nuclear power, and food and drug law, and where he argued dozens of appellate cases, including several in the U.S. Supreme Court.

Bill taught at Georgetown University Law Center for 10 years (Food and Drug Law; Civil Litigation). He regularly speaks about health care issues and has authored numerous articles on health care and other topics.

Education
  • University of Virginia School of Law, J.D., 1974
     
  • Yale University, B.A., 1970
Bar admissions
  • District of Columbia
  • Virginia
Court admissions
  • U.S. Supreme Court
  • U.S. Court of Appeals, District of Columbia Circuit
  • U.S. Court of Appeals, Federal Circuit
  • U.S. Court of Appeals, Fourth Circuit
  • U.S. Court of Appeals, Ninth Circuit
  • U.S. Court of Appeals, Sixth Circuit
  • U.S. Court of Appeals, Third Circuit
  • U.S. District Court, Eastern District of Virginia
  • Court of Appeals of the District of Columbia
  • Virginia Supreme Court
Clerkships
  • Hon. William B. Bryant, U.S. District Court for the District of Columbia
Government service
  • General Counsel
    • U.S. Department of Health and Human Services
       
  • Deputy Assistant Attorney General
    • U.S. Department of Justice
       
  • Deputy Commissioner for Policy
    • U.S. Food and Drug Administration
       
  • Counsel
    • Subcommittee on Health and the Environment
    • House Committee on Energy and Commerce
    • U.S. Congress
Professional leadership
  • Leadership Council, Yale School of Public Health
  • Board, Historical Society of the District of Columbia Circuit
  • Member, Committee on Science, Technology & Law, National Academy of Sciences
  • Board Member, National Health Law Program
  • Board Member, Partners In Health
Representative matters
  • Represents several hospital trade associations and hospitals in a judicial challenge to a Health and Human Services rule that would cut reimbursement for pharmaceuticals by $1.6 billion.
  • Regularly provides strategic advice to regulated companies and trade associations.
  • Serves as an arbitrator in a complex contract matter.
  • Regularly represents generic manufacturers in navigating the regulatory requirements at FDA.
  • Worked extensively on regulations implementing the Affordable Care Act and litigation involving the Act, as well as regulations and litigation related to FDA and other HHS programs.
  • Represented numerous clients before the U.S. Supreme Court and federal appellate courts.
  • Provided strategic advice to clients subject to Congressional investigations.
  • Represented a leading generic manufacturer in congressional negotiations regarding biosimilar legislation.
  • 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.
  • 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. Also represented this client when it prevailed in defeating a motion for a preliminary injunction seeking to stop FDA from approving its generic.
  • Provided expert testimony at Congressional hearings on numerous issues.
  • Advised the New York City Board of Health on preemption case brought to block implementation of its requirement for labeling in restaurants.
  • Acted as counsel to a state in efforts to facilitate the importation of prescription drugs from Canada.
  • Represented leading public health group in legislation to give the FDA jurisdiction over tobacco products.
  • Represented generic manufacturers seeking generic exclusivity for a popular diabetes drug, a cholesterol lowering agent, and an epilepsy drug.
News
Recognitions
William B. Schultz_bio

William B. Schultz

Partner

Office
Washington, DC
Tel.
+1 202.778.1820
Fax.
202.822.8106
Others
Send an Email
vCard
LinkedIn