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Lester M. Crawford, D.V.M., Ph.D. - Food and Drug Law Institute

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
Food and Drug Law Institute

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

Acting Commissioner of Food and Drugs

 

April 7, 2005

INTRODUCTION
Thank you, Patrick, for the kind introduction. I am truly pleased to be here this morning to address FDLI’s annual conference. I am especially pleased that FDA is a co-sponsor of this event. Your members have established a vital relationship with our Agency and I know the FDA values that relationship.

We have some fine FDA experts who will address you at this conference, including our Acting Chief Counsel Gerry Masoudi and Steven Niedelman of our Office of Regulatory Affairs. I also appreciate Senator Enzi and my predecessor Dr. McClellan for their time in addressing this conference.

I wanted to take this opportunity today to give you a summary of FDA accomplishments since last year and then outline our strategic priorities for the future.

2004 in Review
In 2004, 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food safety through major initiatives and actions, and we streamlined paperwork process to reduce errors, reform outdated practices, and enhance new product innovation.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, our successes are continually challenged by emerging health threats, changes in technology and variant global market forces. 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.

I want to take some time to outline for you some of our strategic goals for the upcoming year.

1) Enabling Technology Development and Innovation
Over the past year, FDA's “Innovation Initiative” has met some important milestones: a root cause analysis of multiple cycle reviews, a pilot program to test earlier communication with product manufacturers, a cementing of our partnership with the National Cancer Institute, and the establishment of an Oncology Office within FDA to foster innovation in the treatment of cancer.

The Agency also launched the Critical Path initiative. The essence of Critical Path is that the process of medical product development has become costlier, lengthier and more uncertain than ever before. There's a growing chasm between bench and bedside, and it is threatening the very promise of biomedical innovation as the research and development community begins to focus on a group of incurable diseases such as Alzheimer's, multiple sclerosis, lupus and cystic fibrosis.

In response to this serious problem, FDA is developing a versatile applied science toolkit containing powerful scientific and technical methods such as animal and computer based predictive models, biomarkers for safety and effectiveness and new clinical evaluation techniques.

The goal is to help predict eventual product failures early during clinical trials and to reduce developmental uncertainties in 3 critical product areas: product safety, medical utility, and manufacturing potential.

Critical Path will, we are convinced, improve predictability and efficiency and get much needed treatments to patients faster.

Later this spring, FDA will announce the National Critical Path Opportunities List, which will pinpoint those areas of product development that could benefit most from innovative approaches and emerging technologies. This will enable us to rally our partners in government, industry and academia to build the path to innovation in these key areas. Although Spring is a little later than we had hoped to announce the List, we are committed to the Critical Path Initiative as a way to improve product development and innovation.

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 also is developing new communication formats to better inform the public of the Agency’s deliberation process.

Drug Safety Oversight Board

In February, Secretary Leavitt and I announced an FDA initiative that will fundamentally and immediately take steps to improve the drug safety system while protecting patient privacy. The newly created Drug Safety Oversight Board will oversee the management of important drug safety issues within our Center for Drug Evaluation and Research (CDER). The Board will comprise members of the FDA and medical experts from other HHS agencies and government departments.

IOM Study

In November 2004, we asked the Institute of Medicine to carry out a top-to-bottom study of drug safety. We look forward to their results and will act swiftly to improve standards for American consumers.

Drug Watch Web page

Finally, FDA is proposing to set up a new Drug Watch Web page for emerging data and risk information. This 21 st 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.

3) Protecting the Homeland - Counterterrorism
The past year has witnessed some of the most significant enhancements to our food safety and security program in decades. Going forward, we will finalize implementation of our new food security regulations and also expand our capabilities through new mobile laboratories, intensified inspections, and closer inter-agency collaboration. Additionally, we will continue to work with public and private sector partners to accelerate the development and availability of safe, new medical countermeasures.

We must be prepared for a wide range of circumstances and contingencies in order to respond effectively to terrorism-related emergencies and crises. We have developed crisis management plans and have strengthened our readiness by partnering with state and federal agencies in conducting emergency response exercises that simulate chemical, biological, and radiological events. While much has been done, there is still much more to do to accelerate the availability of medical countermeasures in case of a catastrophic event.

4) Improving Manufacturing Practices
Good manufacturing practices are not only vital to business success; they are also essential to FDA and they are essential to the public health.

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. Just last month, 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. FDA will still need to conduct a comprehensive GMP inspection as follow up to FDA’s December warning letter.

I’m pleased also to tell you that the Department of Health and Human Services just this week awarded a $97 million grant to Sanofi Pasteur to develop cell-based Influenza Vaccine. The five-year award will support the development of advanced techniques using a cell-based, rather than an egg-based, approach to producing vaccines. It is another front to avoid what happened last year and speed up the production of vaccines for our future pandemics.

5) Improving FDA’s Business Practices
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 White Oak. 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.

CONCLUSION
A physiologist of the 19 th century described the brain as a “fantastic weaving shuttle,” a term of amazement. One could describe the FDA of today as just that.

As the work of our Centers and field force come together to provide a protective tapestry for the American people, we fully realize that tomorrow will present new hazards that will need to be addressed. We know we can only do this through the application of science, reason, and hard work.

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 very much for having me and I look forward to working with you in the future. I will be happy to take some questions.