Frank J. Sasinowski, JD, MPH

The world has many extraordinary people who are able to rack up achievements at a near-superhuman pace. But there are far fewer people who use their exceptional talents to benefit humanity. They are the ones who don’t seek to make headlines or accumulate riches, but work, as the saying goes, “for the good of others.” Frank Sasinowski, distinguished by his commitment to approving treatments for rare and devastating illnesses, is one of these people.

Sasinowski has assisted in the approval of hundreds of new drugs, including over 100 that address rare and serious conditions that don’t often garner worldwide attention. He distinguishes himself by recognizing that a disease need not be common to be debilitating and that the value of even just one life saved is incomparable. Sasinowski calls his work his “ministry” – a method through which he exercises his faith.

Though he has distinguished himself as a lawyer, Sasinowski didn’t start out that way. An early love of science led to a degree in genetics from Cornell University, followed by two master’s degrees at The University of California, Berkeley in physiology, nutrition and public health. His expertise led him to testify before California legislators when he saw a clear need to improve funding for school meal programs. That experience rekindled Sasinowski’s interest in law, and showed him how, from the legal side, he might make a large and lasting impact on the world. He made himself the key missing link needed to take scientific achievements from the lab bench to the bedside.

After studying law at Georgetown University, Frank served a stint in the USDA and the American Public Health Association, again helping improve nutrition, but soon transitioned to the Food and Drug Administration. In 1983, he joined the FDA 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. Both of these created incentives for pharmaceutical companies to research and develop cures for rare diseases that were once seen as unprofitable.

Sasinowski’s conviction that no cure is ever wasted was cemented into law and has now changed how drug companies approach rare conditions. Giants in the drug development world, aided by this legislation and Sasinowski’s guiding eye, have now pursued over 500 therapies for rare diseases. For his work, he has already been awarded the National Organization for Rare Disorders’ Lifetime Achievement Award.

Although he has dealt with complex science, and even more baffling legal pursuits, Sasinowski has never lost sight of why such work needs to be done. Sasinowski has answered the prayers of countless people with rare diseases who, at one time or another, may have felt that no one was listening. If you ask Sasinowski why, he’ll tell you that he sees God in each and every one of their faces.

It is for doing the Lord’s work, and for striving to heal the world one person at a time, that we award Frank J. Sasinowski the 2021 Pontifical Hero Award for Inspiration for his unwavering advocacy for those with rare diseases.