William T. Koustas
J.D., American University Washington College of Law, served on the Administrative Law Review
M.S., Biotechnology, University of Pennsylvania
B.S., Molecular Biology, University of Denver
District of Columbia
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William T. Koustas works in the areas of prescription drugs and biologics, PDMA and state licensing, the recently enacted Drug Supply Chain Security Act (DSCSA), and advertising and promotion. He helps pharmaceutical companies with FDA product development (including orphan drug issues), regulatory compliance, submission strategies, and promotional review. Mr. Koustas helps clients including manufacturers, wholesalers, and dispensers implement the DSCSA and comply with state licensing requirements for the distribution of prescription drugs and devices. In the area of advertising and promotion, Mr. Koustas sits on a promotional review committee and advises clients on marketing materials and ongoing brand management. In addition, Mr. Koustas manages the REMS database for the firm's FDA Law Blog.
Before pursuing his law degree, Mr. Koustas was a research associate at Myogen, a biotech pharmaceutical company, where he developed firsthand experience in drug development and biologics from the industry perspective. Mr. Koustas was also a law clerk at MedImmune.
Advertising and Promotion
• Advises clients and reviews materials regarding advertising and promotion for prescription drugs.
• Participates in review committees, assisting with new product launches and ongoing brand management.
Prescription Drugs and Biologics
• Advises on developing matters involving general FDA product development, regulatory compliance policies, and FDA submission strategies.
• Provides counsel on drug development matters, including FDA meetings and interactions.
• Assists on strategies for orphan drug products and designations.
DSCSA, PDMA, and State Licensing
• Advises clients on the implementation of the DSCSA.
• Assists clients with issues involving PDMA and regulations, including those related to pedigree.
• Advises on state licensing and pedigree requirements, including wholesale distributors and pharmacies.
• Assists with obtaining state licenses for manufacturers, wholesale distributors, and pharmacies.
• Provides counsel on internal investigations related to DEA enforcement issues.
• Works with manufacturers, wholesalers, and dispensers of controlled substances on applicable state regulations.
Colorado Bar Association
District of Columbia Bar Association
Articles / Publications
Trends in FDA's Use of Class-Wide REMS,
Search Warrants - What Happens When the FDA Storm Arrives,
HDMA Traceability Seminar, November 10-12, 2014
see more blog entries
FDA Releases Draft Guidance on Wholesale Drug Distributor and 3PL License Reporting Under DSCSA,
December 10, 2014
Something to be Thankful For? FDA Issues Long Awaited DSCSA Guidance,
December 1, 2014
Without Much Fanfare, FDA Creates System for DSCSA Licensure Reporting,
December 1, 2014
FDA Speaks at Annual HDMA Track-and-Trace Conference,
November 13, 2014
FDA Q&A Draft Guidance Clarifies Issue of DSCSA Preemption of State Track and Trace and Licensing Requirements,
October 9, 2014