Steven’s Remarks on Accepting the RUF Award for His Advocacy and Policy Leadership

This week, I was honored by the Reagan-Udall Foundation for the FDA with their Innovations in Regulatory Science Award for my advocacy and policy work. Here are the remarks I gave at the award dinner:

Good evening…..

My thanks to the Reagan-Udall Foundation and its CEO, Susan Winckler. The Foundation has become a pivotal force for a stronger and more effective FDA. It makes this award an even greater honor.

I also want to thank my family —my son David and his wife, Soumi, my daughter Emily and her husband Mike, my wife Barbara,  and my sister, Ellen. They have all supported me throughout my career. There are a few insights I would like to share. 

The first insight is that “no good thing is ever the product of just one person.”

In the case of the Alliance for a Stronger FDA, it was a very “iffy” proposition in 2006, far more so than any of you can imagine.

It was foresightful and actually quite brave for Nancy Myers, Wayne Pines, and Diane Dorman—my co-founders--to sign the incorporation papers and become the Alliance’s first board of directors. Ladd Wiley joined our inner circle not long after.

It took all of us together—and a lot more--to build the Alliance into a success.

The same can be said about my earlier time in the Senate. Congressman Waxman and Senator Hatch believed in bipartisan legislation. Even still, the Orphan Drug Act and Hatch-Waxman were only possible because of the efforts of the FDA stakeholder community----staffers like me, patient and consumer advocates, associations, and companies.

With that same communal spirit, we need to continue to work together for the betterment of FDA and the benefit of the American people.

My second insight is about FDA progress and the role of regulatory science. 

Throughout my career, I have heard prophets of doom claim that biopharmaceutical innovation would dry up soon because “all the low-hanging fruit has already been picked.”

It is a crazy but remarkably persistent notion. I last saw a reference to it earlier this year in a letter to a journal editor!

What I see, instead, is progress. Today’s groundbreaking accomplishments are eventually seen as yesterday’s “low-hanging fruit.”

We never quite know what is coming next. Yet, we keep managing to climb the tree of biopharmaceutical innovation, continuously redefining upward the criteria for low-hanging fruit.

Similarly impressive, but less widely recognized, are the innovations that have modernized our food systems.

The key is that FDA must keep growing and learning. As part of that, regulatory science needs to evolve as a tool that can help us resolve ever more sophisticated questions about science, medicine, and food safety.

I am still very much dedicated to the regulatory science cause. I hope, by your attendance tonight, that you are, too.

A final thought…… 

As most of you know, I will be leaving the Alliance after 18 years.

Many of you know me only through my writing. In the new year, I look forward to writing more broadly about the FDA and sharing it with the community.

I am also looking for the next opportunity to draw the stakeholder community together to make large and meaningful differences….maybe Hatch-Waxman 2.0….maybe food additive user fees?

I have had the good fortune to find something I care deeply about and the opportunity to pursue it full-time. Again, my thanks to everyone who made that possible.

Let us keep working together as a community. Thank you.

Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.