1800 M STREET, NW
SUITE 1000
WASHINGTON,
DC
20036-5807
202.778.1862
202.822.8106 fax
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Carmen M. Shepard represents generic pharmaceutical manufacturers in matters related to exclusivity challenges and high-stakes Hatch-Waxman litigation. She also counsels companies involved in regulatory filings and proceedings, including assessing the available approval pathways for generic drugs using 505(j) and 505(b)(2) applications. She counsels companies and individuals on how to navigate U.S. Food and Drug Administration (FDA) enforcement and compliance matters, ranging from inspections to criminal investigations. Ms. Shepard has assisted companies responding to 483s, warning letters, and import alerts, in addition to negotiating consent decrees. She also has represented individuals facing government investigations with potential civil and criminal liability. She has built her food and drug practice upon experience with federal and state regulatory agencies including the FDA, Consumer Product Safety Commission, and Federal Trade Commission, as well as with multi-state actions brought by state attorneys general.
Ms. Shepard began her career as a trial attorney for the U.S. Department of Justice where she litigated commercial disputes, including civil fraud and government contracts. Later, she embarked on a career with the Maryland Attorney General’s Office. She ascended the ranks from Deputy Chief of Civil Litigation to Deputy Attorney General. Notably, Ms. Shepard served as lead courtroom counsel in Maryland’s battle with the tobacco industry, ultimately securing billions in damages for the state.
Experience
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Represented a generic drug manufacturer in obtaining and defending 180-day exclusivity for atorvastatin.
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Represented the manufacturer of a medical abortion drug in Freedom of Information Act (FOIA) litigation to protect confidential commercial information, and employee and patient identifying information.
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Represented a pharmaceutical manufacturing facility in an action to dissolve a consent decree.
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Represented an individual who was targeted in an FDA investigation; the individual was ultimately not named as a defendant in the FDA consent decree.
EDUCATION
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Yale Law School,
J.D.,
1980, John Fletcher Caskey Prize
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Yale University,
B.A.,
1976
COURT ADMISSIONS
- U.S. Supreme Court
- U.S. Claims Court
- U.S. Court of Appeals, Federal Circuit
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. Court of Appeals, 4th Circuit
- U.S. District Court, District of Maryland
- U.S. District Court, District of Columbia
- District of Columbia Court of Appeals
- Maryland Court of Appeals
BAR ADMISSIONS
- District of Columbia
- Maryland
MEMBERSHIPS
- Committee on Litigation and Legal Priorities, American Civil Liberties Union (ACLU) of Maryland
- Member, Maryland Judicial Campaign Conduct Committee
- Instructor, Food and Drug Law Institute
- Former Chair, Federal Court Advisory Committee
- Former Program Director, National Institute for Trial Advocacy
- Former Co-Chair, Committee on Racial and Ethnic Fairness, Maryland Court of Appeals
- Former Trustee, St. Mary’s College
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PRACTICES
Related Information
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