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Statement on Blood Safety and Availability by David Satcher, M. D., Ph. D.
Assistant Secretary for Health and Surgeon General
U.S. Department of Health and Human Services

Mr. Chairman, Members of the Committee:

Thank you for your invitation to discuss the safety and availability of the blood supply.

I. RECENT ADVANCES IN BLOOD SAFETY

Our nation's blood supply is safer than it ever has been, and it is getting safer even as we speak. Dr. AuBuchon, who testified before you last month, reported just two years ago that the risk of hepatitis C from blood transfusion was about one in one hundred thousand transfusions, or about 120 cases per year. He also reported that the risk of HIV was about one in five hundred thousand transfusions, or about 24 cases per year.

Since then, nucleic acid tests for hepatitis C and HIV have been developed. Most older tests, which produced the results Dr. AuBuchon described, detect antibodies to these viruses. In contrast, nucleic acid tests detect the viruses themselves. For this reason, nucleic acid tests may help us close the so-called "window period"between the time an infectious agent appears in the blood and the time that infection can be detected.

Currently, nucleic acid tests are investigational, and are being evaluated widely using pools of donated blood. Even more sensitive nucleic acid tests performed on single units are under development. Collectively, these advances should reduce the risk of transfusion-transmitted hepatitis C and HIV by an order of magnitude, and possibly even more.

II. DEPARTMENT ACCOMPLISHMENTS IN BLOOD SAFETY

A. PRIORITIZATION OF BLOOD SAFETY WITHIN THE DEPARTMENT

Our efforts to increase the safety of the blood supply began in the earliest days of this Administration. In July 1993, Secretary Shalala commissioned the Institute of Medicine to prepare a report on the introduction of HIV into the blood supply. She did this, as she said at the time, "... to insure the safety of the Nation's blood supply against new challenges in the future."

The Institute of Medicine released its report in July 1995. On the day it was released, the Secretary directed Dr. Lee, then the Assistant Secretary for Health, and senior members of the Department to review it. In October of that year, in testimony before Congress, the Secretary announced her concurrence with the report. She also announced that she had designated the Assistant Secretary for Health to be the Blood Safety Director for the Department. In addition, she announced the establishment of two high-level Committees on blood safety and availability, one internal and one external to the Department. The Secretary concluded her testimony by saying

We are implementing the Secretary's policy by:

1. Timely introduction of new technologies, such as nucleic acid testing;
2. Proactive response to the threats posed by emerging and re-emerging infectious diseases, such as transmissible spongiform encephalopathies; and
3. Increased attention to quality assurance, such as emphasis on current Good Manufacturing Practice requirements.

We believe that these three initiatives will permit us to achieve the degree of blood safety that the American people demand without compromising the blood availability that the American people need.

B. BLOOD ACTION PLAN

I feel it is important to stress, in light of earlier discussion by this Committee, the commitment of the Food and Drug Administration to increasing the effectiveness of regulation of the blood industry. The concrete expression of this commitment is the Blood Action Plan, which was initiated in July 1997. The Blood Action Plan is one of FDA's responses to the 1995 Institute of Medicine report, and also to several congressional oversight reports since that time.

The Blood Action Plan established a comprehensive review of all blood-related regulation. Most of this review has been completed. In May and August of this year, FDA published Direct Final Rules, and companion Proposed Final Rules, that updated technical standards for blood and blood products. In August of this year, FDA proposed two additional rules, one on testing blood donors for infectious diseases, and another on donor notification. Also, in August 1999, FDA proposed an important consumer safety initiative: a tracking system for plasma derivatives from manufacturer through the distribution network to the end user that will insure prompt notification when indicated.

Progress has also been made in improving responsiveness of the Agency. Under the Blood Action Plan, FDA is harmonizing its new Biologics License Application for blood products with its New Drug Application. In addition, FDA, CDC, and NIH representatives have formed an Emerging Infectious Diseases Committee that has developed plans for responding to emerging infections that threaten the blood supply. FDA has also reorganized its field inspection programs. As a result, there has been considerable progress towards bringing the blood and blood products industries into full compliance with current Good Manufacturing Practice requirements.

C. HEPATITIS C LOOKBACK

In the interest of time, I will only briefly mention the Department's initiative to notify all individuals who may have been inadvertently exposed to hepatitis C through blood transfusion. FDA has moved rapidly to issue Guidances on this initiative, and it is moving rapidly as well to issue a Final Rule on this matter. As part of this effort, CDC is coordinating a Hepatitis C Public Information Campaign and, in collaboration with FDA and the Agency for Health Care Policy Research, will carefully evaluate both the targeted and the general notification efforts.

D. DEFENSE AGAINST TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

Over the past four years, the Department has substantially updated its policies regarding the transmissible spongiform encephalopathies. These include Creutzfeldt-Jakob disease, or CJD, and new variant CJD, the human form of "mad cow" disease. Animal experiments indicate that both are potentially transmissible by blood transfusion, but no actual case of this has so far been observed in humans.

Extensive epidemiologic data has permitted us to revise some precautions against CJD. However, new and disturbing information about new variant CJD has recently become available. We have learned that the prion of new variant CJD is different from the prion of classic CJD. This may explain why the clinical manifestations of the two diseases are so different. We have learned that the prion of new variant CJD forms deposits in peripheral tissues, and there is some preliminary evidence in transgenic mice that suggests a role for certain blood cells in the pathogenesis of this disease. We have learned that blood from rodents experimentally infected with Mad Cow Disease can, under some circumstances, transmit it to other rodents. We have learned that the risk of new variant CJD is uniformly distributed throughout the United Kingdom. In fact, the only definable risks of new variant CJD at present are long-term residence in the United Kingdom, and methionine homozygosity at codon 129 of the PRNP gene."

The first critical piece of information we currently lack is the length of the incubation period between exposure to the agent of new variant CJD and the onset of symptoms. In cows it is five years. If it is also five years in people, there may be no more than 500 victims of this disease. However, if the incubation period is up to forty years, there could be more than 500,000 victims of new variant CJD.

The other critical piece of information we currently lack is whether new variant CJD is in fact transmitted by blood transfusion in man. No such instance has yet been identified, but the possibility has not been excluded. Some have suggested that we take no action until the first case of transfusion-transmitted new variant CJD is documented. However, by that time, how many others might be irreversibly infected with a uniformly fatal disease that destroys the brains of its victims in the prime of their lives? We have chosen to reduce this risk by the limited methods now available to us, and not wait until the answer reveals itself.

In formulating our policies, we have repeatedly invited comment from scientists, the blood industry, and the public on their perception of the risk to blood safety posed by new variant CJD to blood safety, the impact of any measures we might take to reduce that risk, and what we could do to minimize that impact. As we expected, the advice varied. For this reason, we followed the process established by Secretary Shalala in 1995, which was to bring this matter promptly to the highest level of the Department. The Food and Drug Administration's Transmissible Spongiform Encephalopathy Advisory Committee made their final recommendation on June 2 of this year regarding donor deferral based on a period of residence or travel in the United Kingdom; the Blood Safety Committee, which I chair, met on June 8. The Blood Safety Committee's recommendation was unanimous in favor of this precautionary measure. FDA announced this recommendation at its Blood Products Advisory Committee meeting on June 17, and FDA's Guidance to Industry was issued on August 16.

III.DEPARTMENT ACTIONS TO ASSURE THE AVAILABILITY OF BLOOD

At the June 8 meeting of the Blood Safety Committee, I appointed an Interagency Working Group to identify strategies to increase the blood supply. I received their report on August 10, and discussed it at the August 26 meeting of the Advisory Committee on Blood Safety and Availability. I concur with each of their recommendations, both for the short and the long term, and I have directed the appropriate agencies to implement these recommendations as soon as possible. Much of this implementation has already occurred.

A. MONITOR THE BLOOD SUPPLY

The first recommendation of the Interagency Working Group was to institute prospective monitoring of the blood supply. The NIH has committed up to $300,000 in the current fiscal year to purchase this data from the National Blood Data Resource Center, beginning as soon as possible, and perhaps even this month. Plans for long-term management of this activity are currently under review.

B. ENCOURAGE THE PUBLIC TO DONATE (AND TO CONTINUE DONATING)

The second recommendation was to increase suitable donations. As the General Accounting Office report to your Committee pointed out, there are plenty of eligible donors; we simply need to find more effective ways to encourage them to donate. The NIH has committed $1.8 million dollars in the current fiscal year to research in this area.

C. IMPROVE RELATIONS BETWEEN DONORS AND BLOOD ESTABLISHMENTS

The third recommendation was to improve relationships between donors and blood centers. While much of this task is the industry's, the Department will consider steps that it can take. For example, there may be ways to make required donor questionnaires less burdensome without making them less effective.

D. REMOVE UNNECESSARY RESTRICTIONS TO DONATION

The fourth recommendation was to review current donor deferral policies, particularly in light of emerging technologies such as nucleic acid testing. FDA's decision to reassess donations by individuals with hemochromatosis that was announced on August 10 by Commissioner Henney is only one of several responses under active consideration by FDA.

E. ADDRESS ECONOMIC CONCERNS OF THE BLOOD INDUSTRY

The fifth and final recommendation was to address economic pressures on the blood industry that may limit its performance. The Advisory Committee on Blood Safety and Availability reviewed this issue at its August 27 meeting. The Committee's recommendations are currently under review within the Department.

IV.OTHER DEPARTMENTAL INITIATIVES IN BLOOD SAFETY

Another issue that both we and you have under active review is accident and error associated with blood administration. FDA has long recognized the importance of reporting, investigation, and correction of errors and accidents. FDA has already used information learned from error and accident reports to identify areas where clinical practice and government regulation could be improved. FDA did issue a Proposed Rule in 1997 to require unlicensed as well as licensed institutions to file these reports, and to quantify the time period in which they should be filed. However, a Final Rule on these matters has not yet been issued.

It is important to emphasize that the error and accident reporting required under this rule serves not to alert the FDA to emergencies, but to provide an additional layer of data for quality assurance, longer-term saftey monitoring, audits, and to help target inspections. The major proactive approach to assuring high quality and compliance with regulations in the blood industry is FDA's regular inspection process. In fact, the vigorous FDA inspection program has led, in recent years, to a number of major enforcement actions which have helped assure blood safety.

Mr. Chairman, I would like to join your fellow Committee members who have thanked you for holding this hearing, because you have raised awareness of an essential layer of the blood safety system. I want to assure you that none of us are waiting for the time required to issue a final rule to address this important matter. As you know, on August 13 of this year I had directed the Advisory Committee on Blood Safety and Availability to place this matter on their agenda. This meeting is scheduled for late January 2000, and preparations for it are already under way. One of the invited speakers will be Dr. Harold Kaplan, the Professor of Transfusion Medicine at Columbia University, who has been awarded a research grant by the National Heart, Lung, and Blood Institute to study transfusion error and how it might be reduced. The Department will promptly consider any recommendations that arise from this meeting, and I would be delighted to inform you of our response to these recommendations as soon as it is formulated.