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Dr. Frank Torti, Acting FDA Commissioner - FDA Science Board

Welcoming remarks
Dr. Frank Torti, Acting FDA Commissioner and Chief FDA Scientist
for the meeting of the FDA Science Board

February 24, 2009


Good morning.

Thank you all for attending this meeting of the FDA Science Board, which advises our agency on emerging scientific issues and keeps us abreast of the latest scientific developments in the academic community and in industry.

Today's meeting represents a completely unheralded, but nonetheless important juncture for our agency. We initiate a new schedule under which the Science Board will meet four times a year, twice as often as in the past. Today is also the first meeting of our Science Board since the revision of the charter to enlarge its membership, and I want to welcome the new Science Board members into the FDA family. Not all of the slots have been filled -- I have left a few slots open for the new commissioner to fill.

What makes today's meeting an important juncture for the FDA, however, are not the increased number of meetings and the greater size of the Board. It is a milestone because it is a result our deliberate strategy to engage the external scientific community in helping us address some of the most vexing problems the FDA faces. It is a process that Science Board member Dr. Barbara McNeil and I began crafting together in October, it is fully operational at today's meeting.

I want to thank for the nominations suggested by industry, the public, and especially the deans of over 100 academic medical centers to whom I wrote for help in identifying candidates for new Board members. They have provided me with many more qualified names than we can appoint -- but I want to assure everyone that all of these names will be reviewed for vacancies on our many expert panels. We intend to put everyone to work.

I want to begin this morning by making good on a pledge I made in May of last year, by presenting to the members of the Board my report, "Status of Regulatory Science at the FDA: Progress, Plans and Challenges". It provides a roadmap for FDA science and responds to many of the concerns raised by the Government Accountability Office, the Science Board report in 2007, reports of the National Academy of Sciences, and others. It is my hope that such a report will become an annual event for future Chief Scientists.

But first I want to take a minute to review the challenges and opportunities we face. We have lost some credibility in recent years. This should come as no surprise to anyone here. How can we regain that credibility?

We owe to the public clear, timely and accurate information on the risks and benefits of the products we regulate. For many of the issues of risk, science does not have all the answers. The FDA must be honest and forthcoming about our uncertainty -- something that can be hard for a regulatory agency to do.

When the science is complex and cannot be encapsulated in a sound bite, we must recognize that oversimplification becomes a kind of demagoguery in its own right.

We need to rebuild our partnership with the members of Congress and others that oversee our agency, by engaging in collaborative efforts to reshape the FDA.

We propose a much closer and broader engagement with the academic community and others in tackling scientific issues that underlie FDA's regulation. Some of those collaborative plans will be evident today.

We acknowledge the creativity of the companies we regulate, and their imagination in developing new products. We need new products and yes, we need safe products. The issue of detection of adverse events, particularly rare events, is a scientific challenge: it involves informatics, personalized health records, mechanisms for coding and tracking devices and drugs, interrogation of complex data sets with a high signal to noise ratio. This is regulatory science and we must tackle these issues.

We must create an environment for our own family of FDA colleagues where politics has no standing in regulatory decisions, where scientific discourse and reasoned disagreements are accepted and respected.

And we need to reward excellence more -- and better.

Even in transition, awaiting a new secretary of health and human services and a new FDA commissioner, there is a great deal we should do, and must do, to drive these processes forward.

We have begun to do so.