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Lester M. Crawford, D.V.M., Ph.D. - National Blood Foundation

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
National Blood Foundation

Leadership Forum

Remarks
by

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

Acting Commissioner of the FDA

April 28, 2004

Good morning, and thank you, John (Barr, Pres. and CEO, V.I. Technologies, Inc.) for the introduction. I appreciate this opportunity to meet and exchange views and ideas with the leaders of our blood industry, a vital component of the community that protects and promotes America’s public health. I appreciate your invitation, including the thoughtful selection of subjects which the organizers of this conference have suggested for my topics. Those issues are also high on the agenda of the Food and Drug Administration, and I'll be happy to address them in a minute.

First, however, I thought it would be of interest if I gave you a brief tour of the FDA horizon following the recent appointment of Dr. McClellan as the Administrator of the Centers for Medicare and Medicaid Services, and my return to the role of Acting FDA Commissioner, which is a post I held before Dr. McClellan became the Commissioner of Food and Drugs in November, 2002.

I'll keep this short and to the highlights. One of them is the appointment of three acting deputy commissioners. Amit Sachdev, who was Associate Commissioner for Legislation, is now Acting Deputy Commissioner for Policy. Dr. Janet Woodcock, the former director of the Center for Drug Evaluation and Research, is Acting Deputy Commissioner for Operations, and Dr. Murray Lumpkin, the former Principal Associate Commissioner, is Acting Deputy Commissioner for International and Special Programs.

With this new leadership team in place, we are working as hard as ever to implement the agency's strategic plan that, as some of you probably know, places great emphasis on risk management, patient safety, health information, counter-terrorism, and scientific and professional excellence of the FDA. I'll mention just two examples of how we’re translating these strategies into public health actions. One example is our white paper that analyzes the uncertainties inherent in what we call the "critical path" of development: the complex processes that bring new pharmaceuticals and medical devices to the market. This unpredictability -- primarily regarding the product's safety, utility, and manufacturing potential -- is a major underlying cause of the recent slowdown in the development of innovating therapies. It slows down the product’s development and increases its costs that can go up to $1.7 billion per drug.

These enormous expenditures are an important public health issue because of their impact on the price of health care products. Our agency is committed to reduce the already record-short review times for drugs, biologics and medical devices by 10.5 percent. But as the white paper points out, much more needs to be done to bring the applied sciences used along the “critical path” to the level of the greatly advanced basic sciences that generate new medical discoveries.

For example, we need to learn how to apply genomic and proteomic techniques to assess the safety of new biomaterials. As you well know, only about 1% of the proteins in blood have been identified, and only about a fifth of this 1% have an FDA-approved diagnostic utility. If we knew more about these proteins, we might be in better position to accurately predict disease remission. Predictability in product development is an issue on which all of us need to work. Incidentally, the white paper is posted on the FDA Webpage, and I highly recommend it to your attention.

There is another top priority public health issue on which we've recently issued a report, and that's America's growing girth -- our tendency to put on, and tolerate, much more weight than is good for us. You've heard the statistics -- almost two thirds of Americans are overweight, and nearly one third are obese. The diseases associated with excessive weight include diabetes, coronary problems and even some types of cancer. Their annual cost to the United States is more than 300,000 premature deaths, which constitute an enormous human tragedy, and more than $100 billion in health care bills and loss of productivity, which is a great economic loss.

At the FDA, we regulate 80 percent of the nation's food, the excess consumption of which – together with a lack of exercise -- causes this epidemic. Last year, we therefore appointed an expert Obesity Working Group to develop ideas for confronting this growing public health problem. A couple of months ago our group issued a report that is also on the FDA Web page, and that I also recommend to your attention. I won't go into the details of the numerous strategies proposed by our group, because I want to have time to discuss matters of more immediate concern for the blood industry. But our emphasis is not only on raising the awareness that calories count, but also on facilitating the choice of healthy diets through such measures as redesigning and making more informative the food label, persuading restaurants to place nutrient information where the patrons can readily see it, and encouraging more realistic serving sizes of packaged food.

The last subject I want to touch upon before addressing the topics suggested by your organizers is the recent achievements and the agenda of our Center for Biologics Evaluation and Research, or CBER, under the leadership of Jesse Goodman. As you may remember, the consolidation of all therapeutic products in our center for drugs triggered some concerns about that much needed reform's impact on CBER's resources and productivity. Well -- and most of you know this already -- those doubts were misplaced.

Today, CBER's proud record shows the following achievements:

  • it has met all goals of the Prescription Drug User Fee Act of 1992, and of the Medical Device User Fee and Modernization Act of 2002 that involve biological components;
  • it has approved flumist vaccine, fibrin sealant, several rapid HIV detection assays, and other complex biological products;
  • and it is vigorously advancing scores of individual projects that are part of FDA's bioterrorism program, which accounts for 25% of CBER's resources.

On top this very full agenda, the center has played a key role in several science-based risk management and other agency initiatives, some of which I'll discuss in a minute.

Right now, I want to turn to the issues I've been asked to discuss by the organizers of this forum because they are of concern to the transfusion medicine community.

The first question I've been asked to answer is, how can we improve our cooperation?

My reply is, in essense, by doing more of what we've done already. As you know, we have a strong record of shared accomplishments with the blood industry we can build on. An outstanding recent example is the final rule on barcoding of medications, including blood components, which was published in February. This need for this measure, which was requested by Tommy Thompson, the secretary of Health and Human Services, was documented in a report of the Government Accounting Office that identified misidentification of patients and drugs as one of the causes of thousands of adverse events that occur in hospitals and clinics each year.

The FDA's response, which was worked out in consultations with all involved stakeholders, was an imaginative use of modern information technology to provide each prescription and certain non-prescription drugs with unique identification code that can be read with a scanner to make sure that each patient is getting the right medication correctly administered at the right time, and in the right form and dosage.

And as you well know, when we were informed that your industry is well underway toward adopting the International Code ISTB 128, which calls for machine-interpretable code of blood components rather than any specific coding system -- such as is used for drugs -- the FDA accommodated that special need.

Another example of our ability to work together is the measures with which we confronted the emergence of the West Nile Virus (WNV). As you will recall, the steps we took were developed in outstanding cooperation among the agencies of the Public Health Service (PHS), the IVD test manufacturers, the blood collection community, and the National Heart, Lung, and Blood Institute which provided substantial support for the development of the screening test for blood donors.

At the FDA, we particularly appreciate the sponsorship of the West Nile Virus Task Force by the American Association of Blood Banks (AABB), and the cooperation of this task force and the test kit manufacturers following the FDA-sponsored workshop on WNV in November 2002.

Together, we took important steps to strengthen transfusion safety including the FDA-recommended deferral of donors who had fever with headache in the week prior to donation, and the implementation last summer of WNV tests in donated blood, which resulted in the removal of 818 potentially WNV infectious blood units nationwide. As the MMWR of the Centers for Disease Control and Prevention (CDC) reported three weeks ago, these measures spared the United States significant morbidity and mortality.

On that subject, I want to note that we've had already the first report of a WNV human case this year, but thanks to our our combined efforts, donor testing is already in place, and there are plans for rapid implementation of individual donor testing in high outbreak areas.

Our capacity and readiness for cooperation is also reflected in the fine tradition of public workshops where FDA, AABB, and the blood collection community openly share data of mutual importance and interest. As you know, over the past 18 months, we've hosted and co-sponsored highly successful workshops on the development of donor screening assays for WNV, on factor VIII inhibitors, and other scientific issues critical to improving blood safety. Moreover, we're about to build on this commendable record in the future.

For example, CBER is planning a workshop on August 31 and September 1st to discuss the development of standards for plasma used in the manufacture of factor VIII, IGIV, and other blood products. The main FDA goal for this event is to gather information on the current practices for the manufacture of plasma for transfusion, source plasma, and recovered plasma. Our experts also want to learn about freezing and storage temperatures used for plasma products, and reexamine the scientific basis for our current requirements regarding these practices.

On September 29, another FDA workshop will discuss FDA's proposals for quality control of leukoreduction of blood components, as well as the latest data regarding the potential value of universal pre-storage leukoreduction. We understand that some of our proposals have raised practical concerns among the industry, and we therefore look forward to the workshop as a forum to share data and views.

As you know, we believe in transparency. Although the FDA must follow to the letter the strict rules of the Administrative Procedures Act on confidentiality of information, we are aware that good communications make for more effective public health protection. We therefore share information and seek stakeholder input through workshops, advisory committee meetings, and liaison with industry working groups.

For example, our agency has participated in the discussions of the AABB's WNV Task Force. Of particular value is our cooperation in collecting key scientific data -- and we can do more of that thanks to co-sponsorship agreements and other mechanisms for joint hosting of public meetings by FDA, PHS agencies, and industry.

We regard this record as a strong evidence of productive cooperation. But I do have a suggestion in response to your question of how we can do better: we can communicate more effectively.

Another topic I've been asked to discuss is problems involved in the screening of blood donors on medical and behavioral history. I welcome this suggestion, because I have important good news on this subject: after four years of hard work, we've published the full-length version of a completely revised blood and plasma donor screening questionnaire. It was issued last Friday as a draft guidance, and is now posted on the FDA Web page.

This guidance, entitled Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components, includes the completely revised blood and plasma donor screening questionnaire developed in cooperation with the AABB Uniform Donor History Task Force. This is a major step toward the much-needed overhaul of the process for determining the eligibility of our blood donor pool.

We still need to upgrade the entire screening process. We're committed to working with the AABB Task Force to develop a short version of the full-length questionnaire for frequent donors, and to establish procedures for keeping the accepted documents current. Our agency also fully supports cognitive testing of proposed new donor questions, and has been working with the AABB to establish the necessary framework and mechanisms.

We recognize the difficulties inherent in the introduction of new screening questions for donors. The changes create need for the development of new standard operating procedures, staff training, modification and re-validation of computer systems, and they inevitably result in donor losses. FDA will try to be more sensitive to these issues in the future.

At the same time, we must be mindful of the potential hazards posed by new disease agents and biological, chemical, and radiological terrorism. FDA, CDC and other PHS agencies therefore need to work with you in developing rapid response mechanisms for the protection of the nation's blood supply in emergencies.

One approach that has merit, and is part of our frequent communications on this critical subject with the AABB Task Force, is the temporary questionnaires used by the blood centers used in response to SARS and WNV. As you know, these questionnaires included candidate questions that eventually would be fully tested and incorporated into the standard donor screening.

Finally, I understand that you're interested in my views on the impact of FDA policies and regulations on the availability and safety of the blood supply. This is an issue of great importance not only the FDA and me, but also the Department of Health and Human Services, which shares your concerns about the availability of the blood supply. And much is being done to meet these concerns.

Perhaps I can remind you that under the department's Blood Action Plan, Assistant Secretary for Health, Admiral Christine Beato in the Office of Public Health and Science, is supervising the creation of a system that will effectively monitor the adequacy of the Nation's blood supply. The monitoring system established in August 2001 is being re-designed to be more representative of the nation as a whole.

Also under consideration at the Secretary's Command Center is a web-based system for rapid assessment of blood inventory shortages, supply and reagent needs, and situational assessment at blood centers and transfusion services in time of emergency. This project is largely based on the TRANS-Net blood shortage reporting system developed and piloted at FDA over the past two years. When fully functional, it will provide blood shortage information directly to both the HHS and the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism.

While FDA does not have direct responsibility for either the monitoring of the blood supply or the recruitment of blood donors, we are alert to the negative impact of questionnaire testing and new deferral procedures on the donor pool. We therefore conduct formal assessments of added safety value vs. donor loss before making any new screening recommendation. Similarly, the FDA takes every opportunity to encourage blood donation and provide conduits for information sharing, such as the Best Practices in Donor Recruitment Workshop we sponsored with the National Health, Lung, and Blood Institute in July 2000.

Another concern we share with AABB is about the incidence of transfusion fatalities and other adverse events related to bacterial contamination of a blood component. Current data indicate that contamination related to skin flora at the phlebotomy site or asymptomatic septicemia in a healthy blood donor occurs on the average of 1 in 2,000 donations, although rates as high as 3% have been reported when blood collection occurs under poorly controlled conditions.

I know that bacterial contamination issues are a strategic priority of AABB, and that they were recently discussed by our Advisory Committee on Blood Safety and Availability. The AABB has announced the formation of a Task Force to address this issue, and FDA looks forward to contribute to its resolution in cooperation with DHHS and the blood community.

I am also aware that a major topic of last month's meeting of the Blood Products Advisory Committee was the need for FDA to update its 1988 recommendations regarding the apheresis platelet collection and quality control. We found the comments of the Committee members as well as the industry representatives most welcome, and our Office of Blood Review and Research is in the late stages of revising our current recommendations.

As part of this revision, FDA is pioneering quality control strategies (including the use of scan statistics) that will make possible standardized assessment of the extent to which biological products are in conformity with a defined standard. We also want to make sure that these strategies can be implemented in a way that is both feasible and user-friendly.

I hope that I have made clear that FDA, the department and I personally are highly focused on the needs of the blood community, and on our shared responsibility for providing the safest achievable blood supply. Assuring that our patients can have the benefits of blood and blood products that are as safe and available as any in the world is a critical part of FDA's public health mission. I look forward to our continued cooperation in advancing progress toward this goal, which is shared by all of us.