HP&M Director Frank Sasinowski Receives NORD Lifetime Achievement Award

Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases.  Of course, this year is extra special; it’s the 30th anniversary of the enactment of the Orphan Drug Act (see our previous anniversary post here) and the 30th anniversary of the founding of NORD.

With 30 years having gone by, you can imagine that NORD had a long list of folks to thank for what some have called the most successful piece of food and drug legislation ever enacted.  Leadership in public policy awards were handed out to Deputy Secretary of the Department of Health and Human Services William V. Corr, Senator Nancy Kassebaum (KS-Retired), and Representative Henry Waxman (CA).  Awards for vision and pioneering guidance were given to NIH Office of Rare Diseases Research Director Stephen C. Groft, former FDA Office of Orphan Products Development Director Marlene E. Haffner, Swedish Orphan International AB founder Lars-Uno Larsson, NORD founder Abbey S. Meyers, and Jess G. Thoene, who served as Chairman of the NORD Board of Directors and edited two editions of the Physician’s Guide to Rare Diseases.  Then NORD announced the recipient of the award for lifetime achievement . . . . Hyman, Phelps & McNamara, P.C. Director Frank J. Sasinowski.

Frank played a major role in implementing the Orphan Drug Act during his tenure at FDA between 1983 and 1987, and was instrumental in two amendments to the law – in 1984 and 1985 – that strengthened the Orphan Drug Act.  Since 2000, Frank has served on the NORD Board of Directors, first as vice chair and later as chair.  More recently, Frank served as the principal analyst and author of a seminal report, titled “Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs,” on the ways in which FDA has exercised flexibility in the review and approval of non-oncologic orphan drug products (see our previous post here).  Congratulations Frank (“Mr. Orphan Drug”)!