Partner
Washington, DC

Clerkships

Hon. William D. Keller, U.S. District Court, Central District of California

Education

University of Michigan Law School, J.D., cum laude, 1997

Brown University, A.B., honors with thesis, 1994

Photo of Alexandra W. Miller

Alexandra W. Miller

Overview
Experience
News
Affiliations

Overview

Alexandra W. Miller focuses her practice on food and drug law and complex civil litigation. In the food and drug area, Ms. Miller represents clients in administrative matters before the U.S. Food and Drug Administration (FDA) relating to drug product approvals and issues arising under Hatch-Waxman. She also has experience representing clients in Hatch-Waxman litigation and advising clients on FDA regulatory issues in connection with transactions. Expand

In the area of complex civil litigation, Ms. Miller focuses on securities litigation, with an emphasis on U.S. Securities and Exchange Commission (SEC) enforcement matters. She has represented individuals both in SEC administrative and federal court proceedings.

Ms. Miller received her A.B., honors with thesis, from Brown University in 1994, and a J.D., cum laude, from the University of Michigan Law School in 1997. After law school, Ms. Miller was a law clerk to the Hon. William D. Keller of the U.S. District Court for the Central District of California.

Professional Highlights

  • At the Wells submission stage of an investigation, successfully persuaded the SEC not to initiate an enforcement proceeding against clients involved in the residential mortgage-backed securities (RMBS) business.
  • Currently represents a former financial industry executive in an SEC enforcement proceeding in federal district court.
  • Successfully defended a generic pharmaceutical company’s right to 180-day exclusivity in federal district court litigation.

Honors

Experience

  • We represented the former chief financial officer of Biovail, then Canada’s largest pharmaceutical company, in a civil enforcement action brought by the SEC alleging failure to meet the requirements of U.S. Generally Accepted Accounting Principles (GAAP) and making misleading statements regarding quarterly earnings. The case settled on favorable terms for the client the day before trial was scheduled to commence.
  • Represented a former portfolio manager in an SEC investigation and enforcement proceeding arising out of the New York Attorney General’s and the SEC’s omnibus investigation of market timing in the mutual fund industry. The SEC filed anti-fraud charges against our client and the case was tried for nine days before an administrative law judge (ALJ). In her decision, the ALJ adopted, in large part, Zuckerman Spaeder’s arguments and declined to impose any bar order or civil money penalties against our client.
  • Successfully represented a generic drug manufacturer in a challenge to the FDA’s approval of its drug. The action for a preliminary injunction was brought by a competitor who claimed that the client had forfeited its 180-day generic exclusivity under the Food, Drug and Cosmetic Act (FDCA). In the first case addressing the generic exclusivity forfeiture provisions of the FDCA, the court refused to enjoin the FDA from approving the drug, allowing our client to continue marketing its drug.

Affiliations

Bar Admissions

  • District of Columbia
  • Illinois (Inactive)

Court Admissions

  • U.S. District Court, District of Columbia
  • U.S. District Court, Eastern District of Michigan

Academic Appointments

  • Adjunct Faculty, Georgetown University Law Center, Spring 2012

Professional Affiliations

  • Member, District of Columbia Bar Legal Ethics Committee

Offices