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Speech before

Drug Discovery Technology and Development

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Commissioner, U.S. Food and Drug Administration

August 10, 2005

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

INTRODUCTION

Good morning and thank you Norman (Peet, IBC Scientific Advisor) for your kind introduction. I also want to thank IBC for organizing such a wonderful and intellectually stimulating conference that really opened up good discussions on some of today’s most important topics in the health care community.

I really enjoyed myself yesterday at the panel discussion and I hope most of you did as well.

As some of you may know, 2006 marks our Agency’s centennial year. It is truly a privilege to serve as Commissioner for this venerable Agency during this exciting time. But as much as we need to celebrate the progresses FDA has made over the last 100 years and its central role in protecting and advancing America’s public health, this is also a time to recast our Agency to the needs and expectation of the American people.

Over the past year and half as Acting Commissioner, I have been able to see clearly that the public has a very high expectation of their FDA. While an overwhelming majority still support the gold standards set by our Agency, more Americans want a better understanding of our decision making process and participation in a meaningful way in the workings of the FDA.

The people look to FDA to provide accurate, useful information about products within its regulatory purview. More and more, the public wants to be able to use this information to control its own health outcomes. In short, “Better Health through Better Information” has become an expected responsibility of the FDA and FDA, as an Agency, is eager to meet this challenge.

Before I go into the FDA priorities, I want to give you all an update on the progress of the FDA over the last year.

Year in Review -- Accomplishments

Over the last year, the FDA once again played a vital role in protecting and advancing public health in the United States. By creating innovative initiatives and improving existing performances, the FDA was able to accomplish many goals that enhanced the lives of Americans.

• We introduced new initiatives to combat critical health threats such as obesity, counterfeit drugs and medical errors;
• We approved a substantially greater number of products, including an unprecedented number of generic drugs;
• We strengthened the security of the nation’s food supply against potential bioterrorism attacks;
• We strengthened food safety through major initiatives and actions; and
• We streamlined the paperwork process to reduce errors, reform outdated practices, and enhance new product innovation.

We are extremely proud of these accomplishments and we will continue to improve on these initiatives. However, emerging health threats, changes in technology and variant global market forces, continually challenge our successes. FDA’s responsibilities are growing in scope and complexity, and we are responding by focusing on new and better ways to perform our core mission.

HHS Priorities

You may know that this past May, HHS Secretary Leavitt outlined his 500-Day Plan to advance America’s health. Several priorities outlined in this plan are tightly linked to FDA’s priorities. The HHS Priorities include:

• Advancing Medical Research
• Transforming the Health Care System
• Securing the Homeland

As I tell you about FDA’s priorities, you will see how these fit into Secretary Leavitt’s 500-Day Plan. There are four main objectives for the FDA.

1. Increase access to innovative technology to advance health
2. Expand patient protection and empower consumers for better health
3. Improve product quality and safety through better manufacturing oversight
4. Modernize the FDA infrastructure

1) Technology Development and Innovation

One of the most exciting efforts at the FDA is our Critical Path Initiative. And this goes to the heart of our discussions over the last couple of days here at this conference. Over the past decade, innovation in product development has actually decreased despite large increases in research spending in both the public and private sectors.

The goal of FDA’s Critical Path Initiative is to stimulate the development of new evaluative tools for assessing the safety and efficacy of new medical products -- tools such as proven biomarkers, innovative clinical trial designs, and simulation models of physiology and disease processes. These tools will do more than revolutionize product development; they will revolutionize the practice of medicine. New biomarkers will help us identify patients who may benefit most from the products; they will also help us identify patients who may respond poorly or not at all to a new medical product. New clinical trial designs will be more informative about an array of treatment issues, including appropriate dosing and target patient populations.

Over the past year, since we published our initial Report diagnosing the scientific component of the pipeline problem, we have heard from our many stakeholders, including many of you, and you’ve told us that our diagnosis is on target. We’ve heard that:

• This revolution in product development will also improve product safety -- these new tools will help product sponsors build safety into new products from the ground up.
• More predictive preclinical models will help sponsors avoid investing in product candidates with toxicities greater than their benefits.
• New biomarkers will help us identify patients who are likely to respond badly to a new medical product.
• New clinical trial designs will be more informative about an array of treatment safety issues, including appropriate dosing and target patient populations.

We are now preparing the 2005 National Critical Path Opportunities List, based on what our stakeholders and the FDA reviewers -- who see the successes and failures industry wide -- tell us are the areas of product development that could most benefit from innovative approaches and emerging technological advances.

The List will identify concrete research that will produce new tools for product development, to fundamentally change and modernize the Critical Path for medical product testing and manufacture in the 21st Century.

We are convinced that Critical Path, once fully implemented, will make the development of novel drugs more predictable and less time-consuming and hazardous. As we lay this groundwork to advance new medical discovery, I look forward to taking with me all the discussion topics that took place at this conference so that the American public can get access to new, effective drugs that can save lives.

2) Patient and Consumer Protection

Of course, helping to bring more and better drugs to those who need them is just one part of the FDA’s mission; another is to make sure that the products we approve are safe for millions of Americans. There has been a lot of public scrutiny over this issue with the recent concerns associated with Cox-2 inhibitors and the Merck withdrawal of Vioxx.

It is important that these concerns do not distort the fact that drugs are safer today than they have ever been before and that millions of Americans each day benefit from them. But in order to improve on current process, FDA has taken some bold steps to enhance the internal deliberations decisions regarding risk and benefit analyses.

FDA also is developing new communication formats to better inform the public of the Agency’s deliberation process. One such tool is the Drug Safety Oversight Board.

Drug Safety Oversight Board (DSB)

3) Improving Manufacturing Practices

In order to maintain the American public’s confidence in FDA’s protection of public health, it is essential that the Agency implement and enforce good manufacturing practices. The FDA’s overhaul of the pharmaceutical cGMPs encourages manufacturers to modernize their methods, equipment and facilities that will help eliminate both production inefficiencies and undue risks for consumers. Our initiative also implements tougher inspections rules to make them more targeted and effective.

Flu Vaccine

One example of our efforts has been the standards we set for GMPs with regards to flu vaccines. Last October, there was a much publicized shortage of flu vaccines partly due to GMP violations by Chiron plants in Great Britain. FDA’s inspection of Chiron uncovered bacterial contamination in 9 of the 100 lots of finished flu vaccines. FDA’s conclusion, based on this evaluation, was that the safety of Chiron’s flu vaccine could not be assured.

By instituting measures for enhanced oversight of flu vaccine manufacture, FDA acted to uphold its rigorous safety standards and protect public health. In April, the British Medicines and Healthcare products Regulatory Agency (MHRA) lifted their suspension of Chiron’s license to manufacture influenza vaccine.

FDA and MHRA will continue to closely monitor Chiron’s progress, including additional inspections. In fact, FDA recently completed an inspection and will be determining soon if Chiron’s vaccine meets comprehensive GMP standards for the coming flu season.

4) Modernize the FDA

Finally, the FDA is seeking to create a stronger and more unified Agency. The increasing complexity of our regulatory mission requires that we look for new ways to create efficiency, standardize processes, enhance infrastructure and improve planning. Some highlights of our plan include:

• Implement shared services, including consolidating information technology infrastructure
• Develop a common business process model
• Continue development of the White Oak campus

When the White Oak facility is completed in 2010, I truly believe the FDA will have the most advanced campus of any regulatory agency in the world. It will truly be a great sight to see our Centers and personnel under one roof since the current setup of more than 80 different locations throughout suburban Maryland make it difficult for face-to-face meetings amongst staff. I think that will generate efficiencies that will help move FDA to its next century of accomplishing its mission.

CONCLUSION

I have just outlined the four pillars of FDA’s vision for our upcoming Centennial year. All four topics also fit well with Secretary Leavitt’s 500-day plans to advance America’s public health.

This is the fourth time I have been at FDA and the second time I have been at the helm. I have been proud of all those stints, but I do believe the present FDA more than ever understands our mission to protect as well as advance the nation’s health, and I’m more than confident that we are equal to the public health imperatives of this day and this time.

Thank you so much again for inviting me to speak and I look forward to answering some questions.

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