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Lester M. Crawford, D.V.M., Ph.D. - World Pharma IT Congress

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.

Speech before
World Pharma IT Congress

Remarks by
Lester M. Crawford, D.V.M., Ph.D.

Acting Commissioner of Food and Drugs

June 6, 2005


Good morning. Thank you for the kind introduction George (Laszlo, Partner at CSC). I want to thank Oxford International for inviting me to speak today.

I think most people would be surprised to find the Commissioner of the Food and Drugs at an IT conference. And certainly, I was asking myself just this question during most of this morning's presentations. However, I think it's significant to stress the importance of IT in the health care industry and that's why I'm pleased to be here today.

I know improving Health IT is a goal I share with our new Secretary of Health and Human Services Michael Leavitt. He has made Health IT one of his key priorities in the Secretary's 500 day plan. I wholeheartedly agree with this approach. If we do our jobs, the power of information technology can address many of the key challenges in the industry today. It will lower health care costs for consumers, lead to fewer medical mishaps and more convenience and better health for everyone in the country. In short, Health IT is a pivotal part of transforming our current health care system.

At the FDA, we are using new technological advances to improve our agency every day. While our responsibilities are growing in scope and complexity, we are responding by focusing on new and better ways to perform our core mission to protect and advance public health. I want to take time today to update you on how technological developments merge with some of FDA's strategic goals.

1) Increase Innovation in Product Development
One of the most exciting efforts at the FDA is our Critical Path Initiative. 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 new technology 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 help us identify patients who may respond badly 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.

2) Patient and Consumer Protection
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 is developing new communication formats to better inform the public of the Agency's deliberation process. One such tool that will use the latest Health IT is our Drug Watch webpage.

Drug Watch Webpage

FDA is proposing to set up a new comprehensive webpage for emerging data and risk information. This 21st Century electronic evolution will bring the power of information directly to consumers and increase the transparency of the Agency's decision-making process.

This site will also enhance public knowledge and understanding of drug safety issues. We are currently in the midst of working with all of the agencies within HHS to develop a sensible format and reporting for this webpage. When it is finished, we hope to offer consumers a comprehensive, informative and state-of-art product that will use latest IT innovations to alert consumers today of the latest news on their health care needs.

3) Modernizing FDA
This brings up the last thing I want to talk about today - that is the need to modernize the agency and bring our technology and methods in line with the 21st Century. While this is not a priority I normally share in speeches with the public, I do believe this is a key point that can be encompassed into every thing we do at the FDA.

Next year, FDA will celebrate our Centennial - That's 100 years of service to protect and advance public health. While we should - and will - celebrate the accomplishments of the past, I believe this will also be a great opportunity for us to look towards the future.

One of the keys to modernizing the FDA, besides the things I talked about earlier today, is to transform on data collection and management into a new age. Technology today has allowed us to transform from paper records to electronic records and this is a goal we will achieve with the help of partners in the industry. No longer should we have to have volumes and volumes of paper data submissions when technology today allows us to put most of it on a disk. No longer should different industry entities conduct the same lab tests over and over again when test results can be shared and used online.

FDA's Part 11 Rule issued in 1997 was the first step to facilitate the transformation from paper record to electronic record. At the time of issuance, there was quite a bit of confusion as to the standards we've set.

That is why in 2003, FDA issued a guidance document on Part 11 that aimed to help industry interpret the rule in its scope, application and enforcement. While I understand there continues to be discussion on the specifics of the rule, I cannot emphasize enough the need for us to move on with standards that is accepted and understood by everyone.

Standards will improve time to market for safe and effective treatment that will increase patient safety and reduce costs. Standards will improve evaluation of the safety and efficacy of investigational treatments. Standards will improve efficiency for clinical research.

While I'm not an expert on this issue -- we do have them at FDA, including a Data Standards Council with representatives from all of our Centers developing health and regulatory data standards for the Agency. But moving ahead on this is an important goal we aim to accomplish.

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 and I am happy to answer some questions.