Frank J. Sasinowski assists sponsors and patient organizations in developing new medicines and has helped secure U.S. Food and Drug Administration (FDA) approval for hundreds of new drugs, including more than 65 new molecular entities, often for serious and/or rare diseases. Mr. Sasinowski joined the 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. In 1987, he left the FDA as deputy director of the health policy staff in the commissioner’s office and joined Hyman, Phelps & McNamara.
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.”
Other papers on accelerated approval and orphan drugs are cited by FDA officials as well.
In December 2014, Frank was appointed an adjunct professor of neurology at the University of Rochester Medical Center.
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 served as chair and as vice chair, and where he remained on the board until 2016. 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. He has also served on the board of directors of the United States Pharmacopeia (USP).