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REMARKS BY:  DONNA E. SHALALA, SECRETARY OF HEALTH AND HUMAN SERVICES
PLACE:       FDA INNOVATIONS IN GOVERNMENT AWARD, WASHINGTON, D.C.
DATE:	     March 3, 1998

There is something vaguely familiar about being here for this event: The FDA receiving a Hammer Award for reinventing government, and an award for innovation in government. Is this something like the twentieth Hammer Award for the FDA? I hope you know because I stopped counting. I am beginning to get the sense that, as Yogi Berra used to say, "It's deja vu all over again."

Truly, it's a great pleasure to join you for this special occasion as we celebrate your excellence, and contemplate what it means to be a public servant. John Gardner, one of our country's greatest public servants and a former Secretary of HEW, once said, "Democracy is measured not by its leaders doing extraordinary things, but by its citizens doing ordinary things extraordinarily well."

Well, the people of FDA do extraordinary things, extraordinarily well for the citizens of our country. In my five years in this administration, in sharing in the leadership of FDA and sharing in every single one of your remarkable accomplishments, I've seen the best of public service first hand. This has been a great honor - because you show how much government can do when we are allowed to do it right.

I am also reminded of the what former Supreme Court Justice Felix Frankfurter once said about government, "It's a pretty complex thing and it requires the dedication, devotion and idealism of our most gifted men and women." Our country is fortunate to have the dedication, devotion and idealism of so many gifted public servants at the FDA.

Every day you work hard and think hard about something both very basic and extremely important to the American people, the safety of the food they eat, the medicine they take, and the medical devices they use. But it's not every day that you get honored, thanked or even noticed for the work that you do. In fact, you have one of those jobs that gets noticed only when things go wrong - so the mark of excellence is anonymity. What else goes unnoticed is just how much harder your jobs have become over the last few years.

In 1992, you were given a monumental task: to streamline the drug review process - and do it without sacrificing quality, safety or the very mission of your organization. You knew that it was not going to be a process of merely shifting a few gears and traveling down the same road, with the same outdated vehicle. You knew that it would be a process of drawing a new road map and drafting new rules for the road. You were right. And you did it.

And, you did it with Einstein's genius: that the greatest ideas are the simplest ones: For that's the genius of the way you changed the drug review process - its simplicity. Drug companies pay user fees, and those fees go to hiring more scientists and improving the information technology infrastructure to make the drug review process more efficient. With the help of new management initiatives, the entire process is now faster and smoother. And, you also developed an even faster review process and ranking system to speed to the market new drugs for serious and life-threatening diseases.

And, the results are nothing short of spectacular. Between 1995 and 1996, we more than doubled the number of new drugs and biological products approved. And, we cut new drug approval time in half - from a median of 30 months to under 14.

Take, for example, AIDS drugs: Since 1993, the FDA has approved 10 new AIDS drugs - including four powerful protease inhibitors - and 20 new drugs for AIDS-related conditions. One of those protease inhibitors was reviewed and approved in only 42 days. And, a year ago, the FDA approved the first protease inhibitor with labeling for use in children.

Today, we have one of the fastest - if not the fastest -- drug approval process in the world. It is, in the truest sense, the reinvention of government that the Vice President has called for and celebrates.

I know it was not easy - it took great effort, thought and care by everyone in FDA. It took great leadership: From visionaries like David Kessler and Michael Friedman. It took all of us working together - the Congress, the public and industry itself - bridging our differences and focusing on our common goals.

So today, I come not just as your boss -- to applaud your work and to bask in the glow of your brilliance. Today, I also come as a citizen to say thank you on behalf of the American people. And, on behalf of all the lives that have been saved, all the people who are living longer, and all the tragedies that have been averted by your creativity and your innovation, your caring and your commitment.

The management theorist Frederick Hertzberg once said, "If you want someone to do a good job, give them a good job to do." You have a monumental job to do - to promote and protect the health and welfare of all Americans. And, you have performed monumentally well - showing the nation what good government can do and the honorable profession of the public servant.

Congratulations and thank you.