Hyman Phelps and McNamara
Frank J. Sasinowski
Photo of Frank J. Sasinowski

(202) 737-4287

Practice Areas
Prescription Drugs and Biologics

J.D., Georgetown University Law Center
M.S., Nutritional Sciences, University of California at Berkeley
M.P.H., University of California at Berkeley
B.S., Biological Sciences and Genetics, Cornell University

Bar Admissions
District of Columbia

Printer Friendly Page

Frank J. Sasinowski, M.S., M.P.H., J.D., assists sponsors in developing new medicines and has helped secure FDA approval for hundreds of new drugs, including more than 45 new molecular entities, often for serious and/or rare diseases. Mr. Sasinowski joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he was key to implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. Mr. Sasinowski twice received the FDA Award of Merit. In 1987, he left the FDA as Deputy Director of the health policy staff in the Commissioner's office and joined this firm.

Mr. Sasinowski's work has been widely recognized by industry and political leaders, as well as notable organizations. For example, Mr. Sasinowski was asked by both political parties to testify at the May 2014 inaugural hearing of Congress 21st Century Cures Initiative. In May 2013, the National Organization for Rare Disorders (NORD), which represents the 30 million Americans with rare diseases, awarded Mr. Sasinowski its first ever NORD Lifetime Achievement Award. In 2000, Mr. Sasinowski was elected to NORD's Board of Directors, where he has served as Chair and as Vice Chair, and where he remains on the Board today. NORD had, in 2000, previously honored Mr. Sasinowski with its Humanitarian Award. In October 2012, President Obama recognized Mr. Sasinowski's contributions to the President's Council of Advisors on Science and Technology (PCAST) report, "Propelling Innovation in Drug Discovery, Development and Evaluation."

Based on his extensive experience with FDA, from both the agency and client side, Mr. Sasinowski possesses a detailed understanding of the regulatory process. He regularly shares his insight on drug development issues with physicians, scientists, and regulators, and has served on the boards of several biotechnology companies. Mr. Sasinowski has been Chair of the Food and Nutrition Section of the American Public Health Association (APHA) and has taught health law at American University. Mr. Sasinowski has also served on the Board of Directors of the United States Pharmacopeia (USP). In its March 2012 issue, the Drug Information Journal published Mr. Sasinowski's seminal analysis on therapies for rare disorders: "Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Cataloguing FDA's Flexibility in Regulating Therapies for Persons with Rare Disorders."

Awards & Recognition
• DC Super Lawyer, 2013 - 2014
• NORD, Humanitarian Award, 2000
• NORD, Lifetime Achievement Award, 2013
• FDA, Award of Merit, 1985 - 1986
• LMG Life Sciences, Life Science Stars, 2013 - 2014
• The International Who's Who of Business Lawyers (Life Sciences), 2014 - 2015
• Academic Appointments Adjunct Professor Neurology University of Rochester School of Medicine (2014 - present)

Professional Affiliations
Chair, Vice Chair, Board of Directors, NORD (2000 - current)
Board of Directors, United States Pharmacopeia
Board of Directors, Shalem Institute for Spiritual Formation (2012 - current)
Board of Directors, Vice Chair, Catholic Medical Mission Board (2002 - 2009)
Charter Member, Advisory Council of Global Camps Africa (2011 - current)
Volunteer Chaplain, Northern Virginia Mental Health Institute (2009 - current)
Chair, Food and Nutrition Section, American Public Health Association (1979 - 1980)

Articles / Publications   
Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs,  March 2012

Speaking Engagements    -    see more speaking engagements
24th Annual Adler Symposium on Alzheimer’s Research at Salk Institute,  February 3, 2015

NORD Rare Diseases and Orphan Products Breakthrough Summit,  October 21-22, 2014  Frank will be speaking about Exploring FDA's Flexibility with Novel Orphan Therapies

21st Century Cures: The President's Council of Advisors on Science and Technology Report on Drug Innovation,  May 20, 2014  Expert testimony

BioCentury This Week, Profiles in Innovation, The Orphan Drug Act,  February 23, 2014

DIA US Rare Diseases and Orphan Products conference,  October 7 - 9, 2013  "The Rising Power of the Patient's Voice in Drug Development and FDA Actions on New Therapies An Analysis of FDA's Subpart H Approvals According to FDA's Draft Guidance on Expedited Programs for Serious Conditions: FDA Flexibility Again!"

Blog Posts   
How Orphan Drugs Came to Be Called “Orphan”,  February 22, 2015