Alexandra W. Miller
Alexandra W. Miller (“Sasha”) is a nationally recognized litigator in food and drug law and focuses her practice on representing clients in FDA regulatory matters and in Hatch-Waxman litigation.
Sasha also maintains a robust civil litigation practice focused primarily on securities and SEC enforcement matters.
In the food and drug area, Sasha represents clients in administrative matters before the 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.
In the area of complex civil litigation, Sasha focuses on securities litigation, with an emphasis on SEC enforcement matters. She has represented individuals both in SEC administrative and federal court proceedings.
Sasha 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, Sasha was a law clerk to the Hon. William D. Keller of the U.S. District Court for the Central District of California.
- University of Michigan Law School, J.D., cum laude, 1997
- Brown University, A.B., honors with thesis, 1994
District of Columbia
U.S. District Court, District of Columbia
U.S. District Court, Eastern District of Michigan
- Hon. William D. Keller, U.S. District Court, Central District of California
- Member, District of Columbia Bar Legal Ethics Committee
- Adjunct Faculty, Georgetown University Law Center, Spring 2012
- Represented the former Chief Business Officer of Freddie Mac in connection with successful settlement of an SEC enforcement action arising from Freddie Mac’s 2006-2008 subprime loan disclosures. The resolution denied all of the remedies the SEC sought and instead resolved the SEC’s claims without the client having to pay any money out of pocket or agree to any restrictions that altered her employment. The case, which received substantial attention when it was brought by the SEC, was vigorously litigated for more than three years, and was favorably resolved near the end of a lengthy discovery process. The firm's work helped the SEC conclude that they were, as put by a lawyer who was not involved in the case "going to have a tough fight on this,” leading to the favorable result for our client.
- Persuaded, the SEC at the Wells submission stage of an investigation not to initiate an enforcement proceeding against clients involved in the residential mortgage-backed securities (RMBS) business.
- Defended a generic pharmaceutical company’s right to 180-day exclusivity in federal district court litigation.
- Represented a former chief financial officer 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.
- 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.
Delaware AG Can Pursue Fraud Claims Against Opioid Makers
February 04, 2019
31 Zuckerman Spaeder Attorneys Recognized in 2019 Edition of The Best Lawyers in America; Three Partners Named “Lawyer of the Year”
August 15, 2018
29 Zuckerman Spaeder Attorneys Recognized in 2018 Edition of The Best Lawyers in America; Partner Mark Foster Named “Lawyer of the Year”
August 16, 2017
30 Zuckerman Spaeder LLP Attorneys Recognized in 2017 Edition of The Best Lawyers in America; Three Partners Named "Lawyers of the Year"
August 15, 2016
Barrier to Generic Competition Threatens Safe, Low Cost Drug Options
October 22, 2015
32 Zuckerman Spaeder LLP Attorneys Recognized in 2016 Edition of The Best Lawyers in America and Three Partners Named "Lawyers of the Year"; Firm is Top-Listed Nationally for White Collar Criminal Defense
August 17, 2015
Zuckerman Spaeder LLP Favorably Settles SEC Case Against Its Client, Former Freddie Mac Executive Patricia Cook
April 15, 2015
17 Zuckerman Spaeder LLP Attorneys Named Washington, DC “Super Lawyers”
April 30, 2013
Zuckerman Spaeder LLP Client Ranbaxy Laboratories Preserves 180-Day Marketing Exclusivity for Generic Blood Pressure Drug
January 03, 2013
Alexandra W. Miller Elected by D.C. Bar Board of Governors to Serve Three-Year Term on D.C. Bar Legal Ethics Committee
May 24, 2012
Zuckerman Spaeder LLP Named to The National Law Journal’s Midsize Hot List for Third Consecutive Year
May 01, 2012
Zuckerman Spaeder LLP Congratulates Former Partner William B. Schultz on His Appointment as HHS General Counsel
April 17, 2012
ZS Ethics Seminar: Ethics and Transactional Matters
Zuckerman Spaeder LLP
October 30, 2008