[House Report 104-746]
[From the U.S. Government Publishing Office]




                                                 Union Calendar No. 392

104th Congress, 2nd Session -  -  -  -  -  -  -  - House Report 104-746

 
 PROTECTING THE NATION'S BLOOD SUPPLY FROM INFECTIOUS AGENTS: THE NEED 
                 FOR NEW STANDARDS TO MEET NEW THREATS

                               __________

                              TENTH REPORT

                                 by the

                        COMMITTEE ON GOVERNMENT
                          REFORM AND OVERSIGHT

                             together with

                            ADDITIONAL VIEWS

                                     



 August 2, 1996.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed


              COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

     WILLIAM F. CLINGER, Jr., 
      Pennsylvania, Chairman
                                     BENJAMIN A. GILMAN, New York
                                     DAN BURTON, Indiana
                                     J. DENNIS HASTERT, Illinois
                                     CONSTANCE A. MORELLA, Maryland
                                     CHRISTOPHER SHAYS, Connecticut
                                     STEVEN SCHIFF, New Mexico
                                     ILEANA ROS-LEHTINEN, Florida
                                     WILLIAM H. ZELIFF, Jr., New 
                                     Hampshire
                                     JOHN M. McHUGH, New York
                                     STEPHEN HORN, California
                                     JOHN L. MICA, Florida
                                     PETER BLUTE, Massachusetts
                                     THOMAS M. DAVIS, Virginia
                                     DAVID M. McINTOSH, Indiana
                                     RANDY TATE, Washington
                                     DICK CHRYSLER, Michigan
                                     GIL GUTKNECHT, Minnesota
                                     MARK E. SOUDER, Indiana
                                     WILLIAM J. MARTINI, New Jersey
                                     JOE SCARBOROUGH, Florida
                                     JOHN B. SHADEGG, Arizona
                                     MICHAEL PATRICK FLANAGAN, Illinois
                                     CHARLES F. BASS, New Hampshire
                                     STEVEN C. LaTOURETTE, Ohio
                                     MARSHALL ``MARK'' SANFORD, South 
                                     Carolina
                                     ROBERT L. EHRLICH, Jr., Maryland
CARDISS COLLINS, Illinois            SCOTT L. KLUG, Wisconsin
HENRY A. WAXMAN, California
TOM LANTOS, California
ROBERT E. WISE, Jr., West Virginia
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, Jr., South Carolina
LOUISE McINTOSH SLAUGHTER, New York
PAUL E. KANJORSKI, Pennsylvania
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
BARBARA-ROSE COLLINS, Michigan
ELEANOR HOLMES NORTON, District of Columbia
JAMES P. MORAN, Virginia
CARRIE P. MEEK, Florida
CHAKA FATTAH, Pennsylvania
BILL BREWSTER, Oklahoma
TIM HOLDEN, Pennsylvania
ELIJAH CUMMINGS, Maryland
            ------
BERNARD SANDERS, Vermont (Independent)

  James L. Clarke, Staff Director
    Kevin Sabo, General Counsel
     Judith McCoy, Chief Clerk
Bud Myers, Minority Staff Director
_________________________________________________________________

    Subcommittee on Human Resources and Intergovernmental Relations

 CHRISTOPHER SHAYS, Connecticut, 
             Chairman
                                     MARK E. SOUDER, Indiana
                                     STEVEN SCHIFF, New Mexico
                                     CONSTANCE A. MORELLA, Maryland
                                     THOMAS M. DAVIS, Virginia
                                     DICK CHRYSLER, Michigan
                                     WILLIAM J. MARTINI, New Jersey
                                     JOE SCARBOROUGH, Florida
                                     MARSHALL ``MARK'' SANFORD, South 
EDOLPHUS TOWNS, New York             Carolina
TOM LANTOS, California
BERNARD SANDERS, Vermont (Ind.)
THOMAS M. BARRETT, Wisconsin
GENE GREEN, Texas
CHAKA FATTAH, Pennsylvania
HENRY A. WAXMAN, California

                               Ex Officio

                                     WILLIAM F. CLINGER, Jr., 
CARDISS COLLINS, Illinois            Pennsylvania
 Lawrence Halloran, Staff Director
 Anne Marie Finley, Professional 
           Staff Member
        Thomas Costa, Clerk
     Cheryl Phelps, Minority 
        Professional Staff
                         LETTER OF TRANSMITTAL

                              ----------                              

                                  House of Representatives,
                                    Washington, DC, August 2, 1996.
Hon. Newt Gingrich,
Speaker of the House of Representatives,
Washington, DC.
    Dear Mr. Speaker: By direction of the Committee on 
Government Reform and Oversight, I submit herewith the 
committee's tenth report to the 104th Congress.

                                   William F. Clinger, Jr.,
                                                          Chairman.

                                     

                            C O N T E N T S

                              ----------                              
                                                                   Page
  I. Executive summary................................................1
 II. Background.......................................................3
III. Findings.........................................................9
 IV. Recommendations.................................................23

                                 VIEWS

Additional views of Hon. Carolyn B. Maloney......................    27



                                                 Union Calendar No. 392
104th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 2nd Session                                                    104-746
_______________________________________________________________________

 PROTECTING THE NATION'S BLOOD SUPPLY FROM INFECTIOUS AGENTS: THE NEED 
                 FOR NEW STANDARDS TO MEET NEW THREATS

                                _______
                                

 August 2, 1996.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

_______________________________________________________________________


  Mr. Clinger, from the Committee on Government Reform and Oversight, 
                        submitted the following

                              TENTH REPORT

                             together with

                            ADDITIONAL VIEWS

    On July 25, 1996, the Committee on Government Reform and 
Oversight approved and adopted a report entitled ``Protecting 
the Nation's Blood Supply From Infectious Agents: The Need For 
New Standards To Meet New Threats.'' The chairman was directed 
to transmit a copy to the Speaker of the House.

                          I. Executive Summary

    In the early 1980's, 10,000 hemophiliacs and 12,000 other 
patients were infected with the human immunodeficiency virus 
(HIV) through blood and blood products. Approximately 300,000 
people were infected with the Hepatitis C virus (HCV), many of 
whom have never been told of their exposure to infection.
    The lessons of these tragedies compel greater vigilance and 
higher regulatory standards to protect the Nation's blood 
supply from emerging infectious agents and blood borne 
pathogens.
    Threats to blood safety are both natural and man-made, as 
aggressive new infectious agents emerge and blood safety 
practices evolve. As a result, substantial improvements are 
needed in coordination between the Public Health Service (PHS) 
agencies within the Department of Health and Human Services 
(HHS), particularly the Food and Drug Administration (FDA), the 
Centers for Disease Control and Prevention (CDC) and the 
National Institutes of Health (NIH).
    At the first of two subcommittee hearings on blood safety 
issues, HHS Secretary Donna Shalala announced that the 
Department's focus on blood safety issues will be expanded and 
elevated, with the Assistant Secretary for Health charged to 
improve the coordination and effectiveness of blood safety 
policy.
    Current FDA and CDC regulatory systems are not adequate to 
meet the aggressive nature of emerging threats to blood safety. 
Product recalls and notification regarding possible exposure to 
blood borne pathogens are not well communicated to physicians, 
pharmacists, patients or the public. Regulation of blood 
collection, testing and the production of blood-derived 
therapeutics is not well coordinated or consistently managed to 
minimize known risks.
    The public is not well served if patients are permitted to 
believe there is no risk in blood transfusions or in the use of 
blood derived therapies. While such risks are extremely small, 
and the U.S. blood supply is safer than it has ever been, 
greater efforts should be made to convey known risks to 
consumers who may wish to minimize even those risks through the 
use of alternative procedures or therapies.

Findings in brief

    1. The blood supply is safer than it has ever been.
    2. The blood supply continues to face new infectious 
disease challenges.
    3. In response to the recommendations of the Institute of 
Medicine (IOM), HHS has begun to implement higher regulatory 
standards to protect the Nation's blood supply from emerging 
infectious diseases and blood borne pathogens.
    4. The public is provided insufficient information on the 
risks of blood and blood products.
    5. The FDA has not effectively managed regulatory review of 
blood issues, particularly its advisory committee on blood 
safety issues, the Blood Products Advisory Committee (BPAC).
    6. Despite a BPAC recommendation to the contrary, the FDA 
took the first step toward closing the ``window period'' of 
possible HIV transmission by licensing the p24 antigen test for 
screening of donated blood.
    7. Fifteen years after the AIDS virus emerged as a threat 
to the blood supply, FDA still has not developed an effective 
system for communicating blood product recalls to pharmacists, 
doctors or patients.
    8. The size of plasma pools for fractionated products can 
increase the risk of infectious disease transmission.

Recommendations in brief

    1. Congress should establish the Blood Safety Council and 
the Advisory Committee on Blood Safety and Availability in 
statute.
    2. Congress should consider establishing an indemnification 
system for individuals who suffer adverse consequences from the 
use of blood and blood products.
    3. HHS should take steps to ensure that the estimated 
300,000 living recipients of blood and blood products who were 
infected with Hepatitis C virus before 1990 are notified of 
their potential infection so that they might seek diagnosis and 
treatment.
    4. HHS should disseminate more clinically useful 
information to providers of care and to the public regarding 
blood safety issues.
    5. FDA should immediately develop an effective system of 
recall notification for blood and plasma products.
    6. FDA should immediately cease its practice of providing 
advance notice of safety and compliance inspections to some 
plasma fractionators.
    7. Plasma fractionators should limit the size of plasma 
pools, with pool sizes determined as much by public health risk 
factors as by production economies of scale.

                             II. Background

    Each year, approximately 4 million patients in the United 
States receive transfusions of whole blood and blood components 
derived from 20 million units of whole blood and blood 
components.\1\ When receiving a transfusion, each of these 
patients forms a very personal bond of trust with one or more 
blood donors and with all those responsible for the collection, 
processing, storage, distribution and administration of these 
potentially lifesaving therapies.
---------------------------------------------------------------------------
    \1\ HIV and the Blood Supply: An Analysis of Crisis Decisionmaking, 
Institute of Medicine, National Academy Press, 1995, p. 1 (``IOM 
Report'').
---------------------------------------------------------------------------
    The advent of the era of antibiotics promoted a complacent 
view among medical professionals and the Federal Government 
that new, fatal, untreatable, infectious diseases were 
afflictions of the past. Tragically, a new retrovirus, Human 
Immunodeficiency Virus (HIV) which produced Acquired Immune 
Deficiency Syndrome (AIDS), challenged that view when it 
infected the U.S. blood supply in the early 1980's.
    CDC Director David Satcher testified at the November 2, 
1995 subcommittee hearing that:

          In the past few decades, many of the best scientific 
        minds in the country expected infectious diseases to be 
        eliminated as a public health problem in the United 
        States. As recent events have shown, these 
        pronouncements were premature. Infectious diseases 
        remain the leading cause of death worldwide and among 
        the most important causes of death in the United 
        States.
          In addition, we are faced increasingly with new and 
        re-emerging infectious disease challenges. At home, we 
        have seen the re-emergence of a public health scourge, 
        tuberculosis; recent outbreaks of food and waterborne 
        illnesses, such as those caused by E. Coli 0157.H7 and 
        cryptosporidiosis; and the emergence of a new hanta 
        virus. On a global front, the worldwide HIV/AIDS 
        epidemic is now in its fifteenth year. We recently 
        witnessed an epidemic of plague in India; diphtheria 
        outbreaks in the New Independent States of the former 
        Soviet Union; and the frightening re-emergence of the 
        Ebola virus in Zaire.
          To meet the challenges posed by infectious diseases 
        and to reduce their potential threat to safety of the 
        blood supply, a strong public health capacity is needed 
        at both the Federal and State levels. At the Federal 
        level, CDC, the National Institutes of Health (NIH), 
        and the Food and Drug Administration (FDA) provide our 
        first line of defense in ensuring that the Nation's 
        blood supply and products made from blood are free of 
        infectious agents.
          The U.S. blood supply is currently safer than it has 
        ever been but the HIV experience in the early 1980's 
        and the more recent experience with Hepatitis C virus 
        (HCV) transmission from intravenous immunoglobulin 
        illustrate the need for continued vigilance regarding 
        unrecognized, uncharacterized, and new threats to the 
        blood supply.\2\
---------------------------------------------------------------------------
    \2\ Protecting the Nation's Blood Supply from Infectious Agents: 
New Standards to Meet New Threats, 104th Cong., 1st Sess., p. 105 
(1995) (``HRIR hearings'') (statement of Dr. David Satcher).

    Threats to blood safety are first detected in those who 
regularly rely on blood derived therapies. They serve as a 
``human shield'' or early warning system for the presence of 
infectious agents in the blood supply. For example, persons 
with severe hemophilia are exposed to more blood products from 
more blood donors than any other patient group.\3\ Hemophiliacs 
\4\ are dependent on clotting factor concentrates, concentrated 
amounts of the deficient clotting proteins, made from the 
pooled plasma of up to 20,000 individuals.\5\ If there is an 
infectious agent in the blood supply, it will be seen in the 
hemophiliac population first.
---------------------------------------------------------------------------
    \3\ July 16, 1996 letter from Stephen Bajardi, executive director, 
National Hemophilia Foundation to HRIR Subcommittee staff (in 
subcommittee files).
    \4\ Individuals with a hereditary deficiency of coagulation Factors 
VIII or IX. Dorland's Medical Dictionary, 28th edition, 1994.
    \5\ IOM Report, p. 1.
---------------------------------------------------------------------------
    Hemophilia is a lifelong, hereditary blood clotting 
disorder which primarily, but not exclusively, affects males. 
In addition, there are an additional 25,200 men and women in 
the United States who rely heavily on multiple infusions of 
blood and plasma protein products, according to estimates 
provided by the NIH Office of Rare Diseases and the National 
Heart, Lung, and Blood Institute.\6\
---------------------------------------------------------------------------
    \6\ NIH correspondence with the HRIR Subcommittee, July 16, 1996 
(in subcommittee files).
---------------------------------------------------------------------------
    In the early 1980's, 10,000 people with hemophilia, fully 
50% of all U.S. hemophiliacs at the time, as well as 12,000 \7\ 
other transfusion recipients, were infected with HIV through 
blood products prior to 1985, when a screening test was 
implemented that could detect HIV antibodies in donated blood. 
Many also unknowingly infected their spouses and children 
before learning of their own infections.
---------------------------------------------------------------------------
    \7\ IOM Report, p. 1.
---------------------------------------------------------------------------
    CDC estimates that 290,000 (approximately 7%) of the 3.9 
million Americans chronically infected with HCV acquired their 
infection from transfusion.\8\ Most of these individuals 
received transfusions prior to the availability of a screening 
test in 1990.\9\ The Institute of Medicine report described HCV 
infection as ``often silent, is one of the major causes of 
cirrhosis, hepatocellular carcinoma, or both, in the United 
States, and is a common precipitant of liver failure 
necessitating liver transplantation.'' \10\
---------------------------------------------------------------------------
    \8\ CDC correspondence with HRIR Subcommittee, July 18, 1996 (in 
subcommittee files).
    \9\ Testimony of Assistant Secretary Philip Lee, HRIR hearings, p. 
29.
    \10\ IOM Report, p. 86.
---------------------------------------------------------------------------
    In 1992, Representative Porter Goss (R-FL), Senator Edward 
Kennedy (D-MA), and Senator Bob Graham (D-FL) asked HHS 
Secretary Donna Shalala to investigate the role of the 
Government in the transmission of HIV to hemophiliacs. HHS in 
turn commissioned the National Academy of Sciences' Institute 
of Medicine (IOM) to review the situation and make prospective 
recommendations to assure greater safety in the blood supply 
from emerging and re-emerging infectious agents. The resulting 
report ``HIV and the Blood Supply: An Analysis of Crisis 
Decisionmaking'' was released on July 13, 1995.
    The IOM concluded that HHS failed to recognize that the 
blood supply was not immune to a new infectious agent, HIV, 
about which there was substantial scientific uncertainty. 
Furthermore, a lack of leadership on the part of the FDA, CDC, 
NIH and the blood collection and plasma fractionation 
industries resulted in a pattern of decisionmaking 
characterized by adoption of the most limited public health 
responses. These inadequate responses did not contain the 
spread of HIV through the blood supply and opportunities to 
prevent primary and secondary infections were missed, with 
particularly tragic consequences for the bleeding disorders 
community.\11\
---------------------------------------------------------------------------
    \11\ IOM Report, p. 208-209.
---------------------------------------------------------------------------
    Other factors were also at work that resulted in the 
infection of large numbers of blood and blood product 
recipients. ``Many of our blood banking centers were created 
over 40 years ago as small community volunteer programs and 
were ill-equipped to respond to the HIV threat. Industry on the 
other hand, failed to respond for other reasons, notably a lack 
of medically knowledgeable management and emphasis on profit 
with a need to maintain productivity in a competitive market.'' 
\12\
---------------------------------------------------------------------------
    \12\ Testimony of Dr. John Penner, p. 48.
---------------------------------------------------------------------------

           THE ROLE OF THE FOOD AND DRUG ADMINISTRATION (FDA)

    The Food and Drug Administration derives its authority to 
regulate biologic drugs, ``any virus, therapeutic serum, toxin, 
antitoxin, vaccine, blood, blood component or derivative, 
allergenic product, or analogous product . . . applicable to 
the prevention, treatment, or cure of diseases or injuries of 
man . . .'' from the 1902 Virus Act. It is the oldest law 
currently administered by FDA (P.L. No. 57-244, 32 Stat. 328 
(1902); 42 U.S.C. 262 (1982)), predating the Federal Food, Drug 
and Cosmetic Act of 1906.
    FDA helps ensure the safety of the Nation's blood supply by 
minimizing the risk of infectious disease transmission and 
other hazards while maintaining an adequate supply. FDA 
oversees all phases of blood preparation and manufacture from 
donor screening and selection and testing to product 
collection, processing, labeling, and storage. FDA's Center for 
Biologics Evaluation and Research (CBER) licenses blood 
establishments that ship blood products in interstate commerce 
and inspects these establishments and more than 2,500 
registered intrastate blood establishments.

    THE ROLE OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    The Centers for Disease Control and Prevention (CDC) is the 
Federal agency responsible for disease and injury prevention. 
CDC's mission is to promote health and quality of life by 
preventing and controlling disease, injury, and disability. The 
agency's name was expanded to include ``prevention'' through 
``The Preventative Health Amendments of 1992.'' \13\ CDC 
articulates its vision for the 21st century as ``Healthy People 
in a Healthy World Through Prevention.'' \14\
---------------------------------------------------------------------------
    \13\ P.L. 102-531.
    \14\ CDC Priorities Paper, April 1995.
---------------------------------------------------------------------------
    CDC evaluates public health problems by applying a four 
step scientific analysis: define the problem, identify risk 
factors, develop and test prevention strategies, and implement 
nationwide prevention programs. CDC conducts its programs in 
collaboration with State and local health departments, national 
and community-based organizations, academia, business, and 
labor.
    The CDC uses its nationwide surveillance system of State 
public health officers to identify and monitor blood-borne 
diseases. CDC believes that its epidemiological investigations 
alerted the Federal Government to the presence of HIV in the 
blood supply, even though a screening test did not become 
available until 1985. Dr. Satcher testified that CDC estimates 
``over 700,000 lives were saved because of the epidemiological 
investigations that were able to show that there was something 
being transmitted through the blood supply and other means.'' 
\15\
---------------------------------------------------------------------------
    \15\ Protecting the Nation's Blood Supply from Infectious Agents: 
New Standards to Meet New Threats, 104th Cong., 1st Sess., testimony of 
CDC Director David Satcher, HRIR hearings, p. 105; and For a Healthy 
Nation: Returns on Investment in Public Health, Centers for Disease 
Control and Prevention, p. 29-30.
---------------------------------------------------------------------------
    The CDC also conducts a Hemophilia Monitoring Project which 
monitors infectious agents in the hemophilia population. The 
CDC maintains an internal working group on blood safety, which 
coordinates blood safety issues and evaluates any new or 
potential threats to the blood supply through the National 
Center for Infectious Diseases (NCID). NCID's mission is to 
``prevent illness, disability, and death caused by infectious 
diseases in the United States and around the world.'' It is 
noteworthy that there is no specific mention of blood in the 
NCID list of priorities.\16\
---------------------------------------------------------------------------
    \16\ Major NCID Prevention Activities, FY 1995, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention.
---------------------------------------------------------------------------
    The CDC's Blood Donor Study,\17\ in conjunction with the 
Red Cross, selected blood banks, and selected local public 
health departments around the country, has been interviewing 
HIV-positive donors at 20 regional centers since 1988 to 
evaluate their risk factors for HIV-1, in order to determine 
their motivations for donating. This will allow investigators 
to estimate the length of time between infection and detection 
of antibodies in individuals who subsequently convert to HIV 
positive status, as well as the current risk of HIV 
transmission from blood transfusions.
---------------------------------------------------------------------------
    \17\ Official title ``An evaluation of the behavioral, donation 
history and laboratory characteristics of US blood donors infected with 
human immunodeficiency virus (HIV).'' CDC communication with HRIR 
Subcommittee, July 17, 1996 (in subcommittee files).
---------------------------------------------------------------------------
    Each month, CDC publishes the HIV/AIDS Surveillance Report, 
which contains the cumulative number of AIDS cases reported to 
CDC, as well as new cases. The data are broken down into 
various exposure categories, including transfusion recipients 
of HIV-infected blood.

          THE ROLE OF THE NATIONAL INSTITUTES OF HEALTH (NIH)

    NIH is the primary agency of the Federal Government charged 
with the conduct and support of biomedical and behavioral 
research. It also has major roles in research training, health 
information dissemination, and health services research. The 
National Heart, Lung, and Blood Institute (NHLBI), one of the 
NIH Institutes, is the principal Federal funding agency for 
research on blood.
    NHLBI sponsors REDS (Retrovirus Epidemiology Donor Study), 
an extensive project to determine the current and ongoing 
prevalence of human retroviruses, as well as Hepatitis C and 
other emerging viruses and infectious agents in blood donors. 
REDS also was designed to determine outcomes of specific non-
HIV infections in affected donors and recipients.
    Because REDS can study repeat blood donors, it can 
determine the retroviral infection rate. So far, REDS 
investigators have found a greater incidence of non-HIV 
retroviral infection in blood donors than they had expected. 
The researchers are also examining why individuals who know 
they have risk factors for retroviral infection continue to 
donate blood.
    A major advantage of the study is its large repository of 
samples collected from blood donors. As new tests for blood-
borne infections are developed, it will be possible to screen 
the stored samples to provide better information on currently 
known retroviruses and on other uncharacterized infectious 
agents. However, the Office of AIDS Research recently 
recommended \18\ that AIDS funds should be redirected from 
supporting research related to the safety of the blood supply 
after REDS funding expires in August 1998.\19\
---------------------------------------------------------------------------
    \18\ Report of the NIH AIDS Research Program Evaluation Working 
Group of the Office of AIDS Research Advisory Council, March 13, 1996.
    \19\ April 30, 1996 NHLBI correspondence with subcommittee staff 
(in subcommittee files); and Report of the NIH AIDS Research Program 
Evaluation, Natural History, Epidemiology, and Prevention Research Area 
Review Panel Findings and Recommendations of the Office of AIDS 
Research Advisory Council, June 7, 1996.
---------------------------------------------------------------------------
    NIH also conducts ongoing research to improve blood banking 
operations and blood safety, such as development of methods to 
destroy infectious agents in blood components and development 
of physician guidelines for the appropriate use of blood 
products. In FY 95, NHLBI awarded $182,892,000 in extramural 
grants through the Blood Diseases and Resources program on 
basic and applied research into diseases which require 
treatment with blood products.
    In 1987, the NHLBI launched a broad education effort by 
establishing the National Blood Resources Education Program 
(NBREP), which was tasked with dissemination of information 
about the blood supply to more than 30 national organizations 
with interests in blood donation, transfusion, and public 
education. NBREP had two goals: to ensure an adequate supply of 
safe blood to meet the Nation's needs, and to ensure that blood 
components are transfused only when therapeutically 
appropriate. This program was phased out in FY 1994 because 
NHLBI officials felt that many of the educational materials 
being developed duplicated materials developed by the blood 
banking community.\20\
---------------------------------------------------------------------------
    \20\ HRIR Subcommittee staff conference call with Sandra Lindsay, 
NHLBI Office of Legislative Affairs, July 16, 1996 (notes in 
subcommittee files).
---------------------------------------------------------------------------

                  THE HRIR SUBCOMMITTEE INVESTIGATION

    The Committee on Government Reform and Oversight's 
Subcommittee on Human Resources and Intergovernmental Relations 
(HRIR) initiated an investigation into the safety of the blood 
supply in April 1995. The subcommittee sought assurance that 
the U.S. Department of Health and Human Services' Public Health 
Service (PHS) agencies, particularly the Food and Drug 
Administration, are aggressively maintaining safeguards to 
detect emerging infectious agents and eliminate blood-borne 
pathogens from the Nation's blood supply.
    Hearings were held on October 12, 1995 and November 2, 
1995. HHS Secretary Donna E. Shalala announced HHS' response to 
the IOM report recommendations at the October 12th hearing. The 
perspectives of consumers, clinicians, and the blood collection 
and plasma fractionation industries on blood safety were also 
heard in testimony at these hearings.
    In addition, FDA supplied approximately 44,000 pages of 
documents requested by the subcommittee on the following dates: 
June 6, 1995; July 5, 1995; July 20, 1995; July 21, 1995; 
August 30, 1995; September 12, 1995; September 21, 1995; 
October 5, 1995; October 6, 1995; December 8, 1995; March 25, 
1996; April 5, 1996; May 6, 1996; May 24, 1996; June 3, 1996; 
June 5, 1996; and June 6, 1996.
    Interviews and/or conference calls were conducted with FDA 
personnel on the following dates: August 8, 1995; September 8, 
1995; November 7, 1995; November 30, 1995; March 6, 1996; March 
26, 1996; April 4, 1996; April 8, 1996; April 9, 1996; April 
18, 1996; April 29, 1996 (two meetings); May 10, 1996; May 16, 
1996; May 24, 1996; and July 17, 1996 (two conference calls).
    NIH supplied requested documents to the subcommittee on the 
following dates: September 28, 1995; October 3, 1995; October 
31, 1995; January 22, 1996; and April 30, 1996.
    Interviews and/or conference calls were conducted with NIH 
personnel on the following dates: October 2, 1995; October 6, 
1995; and July 17, 1996.
    CDC supplied documents to the subcommittee on December 27, 
1995.
    Interviews and/or conference calls were conducted with CDC 
personnel on the following dates: September 20, 1995; October 
31, 1995; and February 13, 1996.
    HHS Office of the Inspector General (OIG) supplied 
documents to the subcommittee on April 18, 1996; April 24, 
1996; and May 2, 1996. OIG staff briefed the subcommittee on 
April 30, 1996.
    Interviews and/or conference calls were conducted with HHS 
personnel on the following dates: September 18, 1995; September 
26, 1995; and December 8, 1995.
    An interview was conducted with Health Resources and 
Services Administration (HRSA) personnel on October 5, 1995.
    Interviews and/or conference calls were conducted with 
American Association of Blood Banks (AABB) personnel on the 
following dates: June 27, 1995; July 27, 1995; October 30, 
1995; and April 25, 1996.
    Interviews and/or conference calls were conducted with 
American Red Cross (ARC) personnel on the following dates: June 
28, 1995; October 31, 1995; February 9, 1996; February 14, 
1996: March 1, 1996; and April 3, 1996.
    Interviews and/or conference calls were conducted with 
American Blood Resources Association (ABRA) and/or ABRA member 
companies on the following dates: August 3, 1995; August 24, 
1995; September 20, 1995; September 21, 1995; October 3, 1995; 
October 13, 1995; October 19, 1995; October 24, 1995; October 
25, 1995; October 26, 1995 (ABRA); October 26, 1995 (ABRA 
member company); October 27, 1995; October 30, 1995 (ABRA 
member company); October 30, 1995 (ABRA member company); 
October 30, 1995 (ABRA member company); March 20, 1996; April 
23, 1996; and May 8, 1996.
    An interview was conducted with International Plasma 
Products Industry Association (IPPIA) personnel on May 6, 1996.
    Interviews and/or conference calls were conducted with 
National Hemophilia Foundation (NHF) personnel on the following 
dates: September 6, 1995; October 24, 1995; December 13, 1995; 
and March 20, 1996.
    Interviews and/or conference calls were conducted with 
Council of Community Blood Centers (CCBC) personnel on the 
following dates: August 8, 1995; September 7, 1995; and October 
30, 1995.
    The subcommittee staff also participated in the September 
22, 1995 Institute of Medicine Forum on Blood Safety and 
Availability and the ABRA Annual Plasma Forum on June 14, 1996.
    The hearing records, documents and interviews of the 
subcommittee's investigation serve as the basis for the 
findings and recommendations of this oversight report.

                             III. Findings

1. The blood supply is safer than it has ever been

    The U.S. blood supply is currently safer than it has ever 
been, due largely to a blood safety system enforced by FDA 
which consists of five layers: donor screening, blood testing, 
donor deferral, inventory management to insure that products 
have been thoroughly tested and that donation records have been 
verified, and mandatory investigation and reporting by blood 
establishments to FDA of any accidents and errors relating to 
these safeguards. Blood establishments are also required to 
correct any system deficiencies that are found.\21\
---------------------------------------------------------------------------
    \21\ Testimony of Dr. Kathryn Zoon, HRIR hearings, p. 88.
---------------------------------------------------------------------------
    Better screening tests for viruses, such as HIV and 
Hepatitis, and viral inactivation measures have increased the 
margins of safety for many blood products since the 1980's. 
However, after infection with HIV, there is a period of time 
known as a ``window'' in which infection may be present but 
antibodies to the virus have not been produced in sufficient 
quantity for detection. This window can last up to 6 months in 
some individuals, but is usually about 20 days. Antigens \22\ 
appear and can be detected sooner, reducing the window by 10 
days or more. Donated blood from persons infected with HIV, who 
do not yet exhibit antibodies to the virus, may be able to 
transmit the disease to others.
---------------------------------------------------------------------------
    \22\ Molecules that stimulate the production of antibodies. ``IOM 
Report'' definition, p. 305-6.
---------------------------------------------------------------------------
    FDA believes, ``Reducing the window period further reduces 
the chances that HIV-contaminated blood will enter the blood 
supply and infect recipients of transfused blood or other blood 
products.'' \23\
---------------------------------------------------------------------------
    \23\ FDA Talk Paper ``FDA Takes Steps To Increase Safety of U.S. 
Blood Supply,'' August 10, 1995.
---------------------------------------------------------------------------
    FDA issued guidance to the blood industry on August 8, 1995 
recommending testing of blood donors within 3 months after the 
licensure of the first HIV antigen test kit. FDA approved the 
first application for licensure of the antigen tests on March 
14, 1996.
    The use of viral inactivation measures in plasma products, 
such as the addition of solvent detergents and/or heat 
treatments,\24\ appears to have eliminated the risk of HIV and 
some forms of Hepatitis from antihemophilic factor 
products.\25\
---------------------------------------------------------------------------
    \24\ IOM Report, p. 92.
    \25\ IOM Report, p. 78.
---------------------------------------------------------------------------

2. The blood supply continues to face new infectious disease challenges

    NIH held a consensus conference on infectious agents in the 
blood supply in January 1995. Several emerging threats to the 
blood supply were identified. The report of that conference 
also discusses the criteria to evaluate, detect and eliminate 
emerging blood-borne agents.\26\
---------------------------------------------------------------------------
    \26\ NIH consensus statement Infectious Disease Testing for Blood 
Transfusions, January 9-11, 1995.
---------------------------------------------------------------------------
    Creutzfeldt-Jacob Disease (CJD) is a spongiform 
encephalopathy \27\ caused by a prion, a newly identified, 
infectious protein. It is noteworthy that prions are not 
bacteria, viruses, or parasitic agents. Prion diseases of 
humans may incubate for 30 years or more.\28\ CJD can only be 
diagnosed with certainty on autopsy of the brain. There is 
concern that consumption of Bovine Spongiform Encephalopathy 
(BSE) or ``Mad Cow Disease'' infected beef could produce a 
variant form of CJD (vCJD) in humans.\29\
---------------------------------------------------------------------------
    \27\ A rare, untreatable and fatal neurological disease; S.B. 
Prusiner ``The Prion Diseases,'' Scientific American, January 1995, p. 
48; and statement of Dr. Ronald Gilcher, HRIR hearings, p. 56.
    \28\ Ibid, p. 51.
    \29\ Ibid, p. 48.
---------------------------------------------------------------------------
    There is a theoretical risk that CJD can be transmitted via 
transfusion of blood or blood products.\30\ CJD has been 
transmitted through tissue transplants such as dura mater \31\ 
and corneas, by injections of human growth hormone pituitary 
extracts and during procedures with contaminated surgical 
instruments.\32\
---------------------------------------------------------------------------
    \30\ FDA's Summary of Meeting (via Conference Call) of 
Transmissible Spongiform Encephalopathies Advisory Committee, July 2, 
1996 (in subcommittee files).
    \31\ ``The outermost, toughest, and most fibrous of the three 
membranes (meninges) covering the brain and spinal cord, Dorland's 
Medical Dictionary, 28th edition, 1994.
    \32\ See supra note 27, p. 49.
---------------------------------------------------------------------------
    FDA stated in November 1994, ``there has never been a 
reported case of transmission of CJD by blood or plasma 
products, and it is not known whether CJD can be transmitted by 
blood. However . . . it is prudent to withdraw the (blood of 
the infected donor and the plasma products made from it) at 
this time.'' \33\
---------------------------------------------------------------------------
    \33\ FDA Talk Paper, ``Voluntary Market Withdrawal of Blood 
Products,'' Nov. 17, 1994.
---------------------------------------------------------------------------
    FDA requires that if a blood or plasma donor meets any of 
the following qualifications, all in-date blood components and 
plasma derivatives should be withdrawn and quarantined and 
consignees \34\ notified: a diagnosis of CJD is discovered via 
post-donation information; a donor has a family member with a 
diagnosis of CJD; a donor has received human pituitary-derived 
hormones, including growth hormone; or a donor has received a 
dura mater transplant.\35\ If manufacturers determine that a 
plasma product is in short supply, they may release the 
quarantined product with appropriate CJD labeling.
---------------------------------------------------------------------------
    \34\ Consignees are hospitals, pharmacies, etc., which may have 
received the affected products, not the patient recipient.
    \35\ FDA Summary of Meeting (via conference call) of Transmissible 
Spongiform Encephalopathies Advisory Committee, July 2, 1996 (in 
subcommittee files).
---------------------------------------------------------------------------
    In the past 7 years, more than 20 reported cases of CJD 
have been confirmed in blood donors in the United States, with 
some level of product recall.\36\ The American Red Cross has 
overseen three major withdrawals since November 1994, that 
together involved more than 200 lots of blood. Each lot has the 
potential to transfuse or be manufactured into products for 
1,000 to 10,000 patients. Bayer, Baxter/Highland, and Sandoz 
have also withdrawn plasma products and albumin due to CJD 
affected donors.\37\
---------------------------------------------------------------------------
    \36\ Ibid; and July 17, 1996 conference call with Dr. Joseph 
Fratantoni, FDA, and HRIR Subcommittee staff (notes in subcommittee 
files).
    \37\ American Red Cross Press Release ``American Red Cross 
Announces Precautionary Voluntary Withdrawal of Plasma Derivative 
Products,'' June 6, 1996.
---------------------------------------------------------------------------
    Also in June 1995, NIH, and the American Red Cross began a 
collaborative study to determine whether CJD could be 
transmitted by blood and blood products. Results will not be 
available until after February or March 1997.\38\
---------------------------------------------------------------------------
    \38\ Conference call with Dr. Paul McCurdy, NHLBI, July 17, 1996 
(notes in subcommittee files).
---------------------------------------------------------------------------
    In April 1995, the American Red Cross, in collaboration 
with the CDC and the New York Blood Center initiated a long-
term investigational lookback study to evaluate the 
transmission of CJD through blood components. The ARC reports 
that ``no cases of CJD have been identified among the 
recipients of blood from donors who subsequently developed CJD, 
but long-term surveillance of these recipients continues.'' 
\39\
---------------------------------------------------------------------------
    \39\ See supra note 37.
---------------------------------------------------------------------------
    Hepatitis C Virus (HCV)--an estimated 300,000 individuals 
\40\ are still alive who acquired HCV infection through blood 
and blood products prior to 1990 because a screening test for 
donated blood was not available. Most of these individuals do 
not know of their infection. A screening test for HCV became 
available in 1990.
---------------------------------------------------------------------------
    \40\ Testimony of Assistant Secretary Philip Lee, HRIR hearings, p. 
29.
---------------------------------------------------------------------------
    Treatment of HCV is usually with interferon \41\ and 
approximately 12-15% of individuals will clear the infection 
with the first treatment.\42\ There is some evidence that 
individuals with HCV who do not respond to the first treatment 
may be able to clear the infection with a second round of 
treatment, or with higher dosages of interferon or combinations 
of drugs. Many infected persons do not develop symptoms. 
Others, however, will develop severe cirrhosis of the liver, 
which will require a liver transplant or be fatal.
---------------------------------------------------------------------------
    \41\ The only FDA approved drug to treat HCV.
    \42\ HRIR Subcommittee conference call with Teresa L. Wright, M.D., 
Associate Professor of Medicine, University of California, San 
Francisco, July 17, 1996 (notes in subcommittee files).
---------------------------------------------------------------------------
    The February 1994 transmission of Hepatitis C virus to 
patients who received immune globulin intravenous (IGIV) 
products illustrates the need for continued vigilance regarding 
unrecognized, uncharacterized and new threats to the blood 
supply. These were the first reported cases of Hepatitis C 
infection from licensed IGIV products and prompted withdrawal 
of the products from the world market.\43\
---------------------------------------------------------------------------
    \43\ Testimony of Dr. Satcher, HRIR hearings, p. 105; and FDA 
February 25, 1994 Talk Paper, Immune Globulin Intravenous Removed From 
World Market.
---------------------------------------------------------------------------
    Hepatitis G Virus (HGV)--accounts for 0.3% if all acute 
viral hepatitis in the United States.\44\ The virus is 
transmissible via blood transfusion and is present in the U.S. 
volunteer blood donor population.\45\ ``The association of the 
virus with chronic liver disease and its presence in patients 
with dual infections due to HBV or HCV is irrefutable,'' 
reported Howard C. Thomas, M.D., of St. Mary's Hospital in 
London.\46\
---------------------------------------------------------------------------
    \44\ Testimony of Dr. Satcher, HRIR hearings, p. 106.
    \45\ J. Linnen, et al. ``Molecular Cloning and Disease Association 
of Hepatitis G Virus: A Transfusion-Transmissible Agent,'' Science, 
271, p. 505, 1996.
    \46\ American Association of Blood Banks Newsletter, Nov. 1994.
---------------------------------------------------------------------------
    Parvovirus B19--is a common virus that has been implicated 
in a wide variety of clinical conditions.\47\ Immunosuppressed 
individuals cannot destroy the virus, which limits blood cell 
production leading to chronic anemia.
---------------------------------------------------------------------------
    \47\ A genus of viruses that infect mammals and birds. Human 
parvoviruses cause aplastic crisis in patients with hemolytic anemia or 
sickle cell disease, spontaneous abortion and fetal death. Persistent 
infection in immunocompromised patients can lead to chronic bone marrow 
failure. Dorland's Medical Dictionary, 28th edition, 1994.
---------------------------------------------------------------------------
    Parvovirus B19 ``is being increasingly recognized as an 
important human pathogen, and has been established as the cause 
of `aplastic crisis' in patients with sickle cell disease.'' 
\48\ Because many hemophiliacs are infected with HIV and 
therefore immunosuppressed, first-time exposure to Parvovirus 
via factor concentrate may present an additional health risk.
---------------------------------------------------------------------------
    \48\ E.A. Lowenthal, A. Wills, P.D. Emanuel, R. Player and J.T. 
Prachal, Sickle Cell Acute Chest Syndrome Associated with Parvovirus 
B19 Infection: Case Series and Review, American Journal of Hematology 
51, 207, 1996.
---------------------------------------------------------------------------
    Chagas' Disease--(also called American trypanosomiasis) is 
an infection caused by the parasite Trypanosoma cruzi and 
transmitted to humans primarily by the reduviid bug. It is a 
major cause of illness and death among poor people in 
developing countries and is endemic in almost all Latin 
American countries. In most cases, Chagas' disease is a mild 
illness. In immunocompromised individuals, however, the disease 
can be severe or fatal.
    If detected early enough, drug treatment can shorten the 
acute phase and decrease mortality, but it is only partially 
effective in curing the disease. Without treatment, infected 
individuals remain chronically infected for their lifetime.
    Chagas' has been transmitted through blood and blood 
products.\49\ Since this disease is not endemic to the United 
States, affected individuals would be unlikely to receive an 
accurate and prompt diagnosis. There is growing concern that 
with increasing immigration to the United States from Latin 
American countries, transfusion could become the primary means 
of transmission in this country. This concern is heightened by 
the fact that many infected individuals are asymptomatic, 
chronic carriers.
---------------------------------------------------------------------------
    \49\ Testimony of Dr. Ronald Gilcher, HRIR hearings, p. 58.
---------------------------------------------------------------------------
    American Red Cross studies prove Chagas' disease is present 
in the Los Angeles/Orange Counties blood donor population. The 
on-going study, which began in April 1994, has found that 1 in 
10,000 donations overall in this region is confirmed positive 
for Trypanosoma cruzi,\50\ although the rate of transmission is 
believed to be quite low.
---------------------------------------------------------------------------
    \50\ ``Evaluation of Blood Donor Screening Strategies for 
Trypsanosoma Cruzi in Los Angeles. E.J. Read, D.A. Leiby, A.A. Pan, 
R.J. Stumpf, R.Y. Dodd, paper presented at the November 9-15, 1995 AABB 
Convention, San Diego, CA.
---------------------------------------------------------------------------
    Bacterial contamination--bacterial contamination of 
transfused blood products is a well-recognized source of 
sepsis, often due to improper preparation of the venipuncture 
site at the time of blood collection as well as improper 
screening of ill donors.
    About 10%-15% of blood product recipients experience an 
adverse reaction and 1% experience a serious side effect. 
Approximately 30 people die each year in the United States as a 
direct result of blood product transfusion. This estimate may 
be conservative because transfusion reactions can mimic common 
post-surgical or intensive care problems. The delayed effects 
associated with the infectious process may be another reason 
for under-reporting of blood product transfusion reactions. One 
example is the transmission of Yersinia Enterocolitica, a 
gastrointestinal microbe from a blood donor which multiplies in 
stored blood.
    According to testimony, Babesiosis,\51\ Cytomegalovirus 
\52\ and Epstein Barr virus \53\ are also occasionally 
transmitted through transfusion.\54\
---------------------------------------------------------------------------
    \51\ A tick born parasite, statement of Dr. Ronald Gilcher, HRIR 
hearings, p. 56.
    \52\ A herpes virus, Dorland's Medical Dictionary, 28th edition, 
1994.
    \53\ ``A virus of the genus Lymphocryptovirus that causes 
infectious mononucleosis. Also called human herpesvirus 4.'' Dorland's 
Medical Dictionary, 28th edition, 1994.
    \54\ Statement of Dr. Ronald Gilcher, HRIR hearings, p. 56.
---------------------------------------------------------------------------
    Unfortunately, many infectious agents are transmitted by 
blood and may not be discovered until weeks, months or years 
after the transfusion.
    The CDC's most significant concerns are with the challenges 
of new infectious agents of which we are now unaware, so that 
uncharacterized threats to the blood supply are detected as 
soon as possible.\55\ The American Association of Blood Banks 
(AABB) is also convinced that it is critical to be vigilant 
with respect to unknown infectious agents in the blood 
supply.\56\
---------------------------------------------------------------------------
    \55\ Testimony of Dr. David Satcher, HRIR hearings, p. 104.
    \56\ Testimony of Karen Lipton, AABB, HRIR hearings, p. 150.
---------------------------------------------------------------------------
    Other infectious agents such as HIV-1 and II, and Hepatitis 
B and C, still continue to be transmitted through blood product 
transfusions, although at a very low rate. Hepatitis A virus 
outbreaks have recently been reported in clotting factor 
concentrates for the first time in the United States.\57\ The 
presence of HIV O variant has been documented recently in the 
United States, and current screening tests for donated blood 
must be modified to detect it.\58\
---------------------------------------------------------------------------
    \57\ Morbidity and Mortality Weekly Report, Centers for Disease 
Control, January 19, 1996, Vol. 45, No. 2.
    \58\ FDA Talk Paper, ``First Group O HIV Infection Reported in the 
United States,'' July 5, 1996.
---------------------------------------------------------------------------
    Assistant Secretary for Health Philip Lee testified that 
``the level of scientific uncertainty in the early and mid-
1980's was very great. There was disagreement among the 
scientists and the physicians on a number of these issues. And 
that same problem we face today. I mean, the scientific 
uncertainty.'' \59\
---------------------------------------------------------------------------
    \59\ Testimony of Dr. Philip Lee, HRIR hearings, p. 23.
---------------------------------------------------------------------------

3. In response to the recommendations of the Institute of Medicine 
        (IOM), HHS has begun to implement higher regulatory standards 
        to protect the Nation's blood supply from emerging infectious 
        diseases and blood borne pathogens

    The IOM presented its report to HHS on July 13, 1995. HHS 
Secretary Donna E. Shalala created a task force of Public 
Health Service agencies to evaluate the recommendations and 
develop an implementation plan.
    At the subcommittee's October 12, 1995 hearing, Secretary 
Shalala announced that HHS accepted all of the recommendations 
put forth by IOM,\60\ except the recommendation to create a 
prospective compensation program for individuals harmed by 
blood and blood products,\61\ similar to the National Vaccine 
Injury Compensation Program.
---------------------------------------------------------------------------
    \60\ IOM Report, p. 13.; and statement of Secretary Shalala, HRIR 
hearings, p. 17-18.
    \61\ Representative Porter Goss (R-FL) introduced a retrospective 
compensation bill in the 104th Congress, H.R. 1023 ``The Ricky Ray 
Hemophilia Relief Fund Act'' to compensate hemophiliacs who acquired 
AIDS through blood and blood products prior to 1987. The bill would 
authorize a $1 billion trust fund to provide payments of $125,000 to 
HIV-infected hemophiliacs, their survivors, and infected family 
members.
---------------------------------------------------------------------------
    HHS will create a Blood Safety Committee consisting of the 
CDC Director, NIH Director and the FDA Commissioner. The 
committee will be chaired by the Assistant Secretary for 
Health. The committee will be advised by the Advisory Council 
on Blood Safety and Availability, which will include 
representatives of industry, consumers, scientific experts, and 
ethicists.
    The Secretary views the Advisory Council as ``a forum in 
which to examine broad public health and societal implications 
of blood safety issues. These include availability, informed 
consent, social choice, the allocation of research resources, 
and the impact of economic factors on availability.'' \62\
---------------------------------------------------------------------------
    \62\ Testimony of Secretary Shalala, HRIR hearings, p. 10.
---------------------------------------------------------------------------
    According to HHS, the Blood Safety Committee will provide a 
high level forum for decisionmaking, priority setting, and 
interagency coordination on an ongoing basis, as well as 
facilitating rapid and effective responses to new developments. 
It will be convened to bring broad-based input from the 
consumer sector, medical care providers, legal and ethical 
experts, and blood products service organizations and related 
industries to consider broader societal concerns around blood 
safety that cannot be resolved through the evaluation of 
scientific data alone.\63\
---------------------------------------------------------------------------
    \63\ Minutes of the Blood Safety Committee, January 17, 1996, U.S. 
Department of Health and Human Services, p. 3.
---------------------------------------------------------------------------
    The FDA's Blood Products Advisory Committee (BPAC) will 
provide expert scientific advice to the FDA on regulatory 
matters relating to the blood supply and human tissues for 
transplantation, which are areas under FDA's regulatory 
authority.\64\ BPAC input will be sought when there is 
controversy over the applicable scientific standard, 
interpretation of clinical trial data, or when outside 
expertise is needed on manufacturing and supply issues in order 
to support FDA regulatory decisions. The BPAC also provides FDA 
with public input on regulatory policy development in these 
areas.\65\
---------------------------------------------------------------------------
    \64\ Ibid.
    \65\ Minutes of the Blood Safety Committee meeting, U.S. Department 
of Health and Human Services, January 17, 1996.
---------------------------------------------------------------------------
    Following the Secretary's October 12, 1995 announcement of 
the creation of the Blood Safety Committee at the hearing, the 
committee met on December 11, 1995, January 17, 1996, April 24, 
1996 and June 11, 1996. Agenda issues have not been released 
and no appointments have yet been announced to the Advisory 
Council on Blood Safety and Availability.
    From the documents provided by HHS to the HRIR 
Subcommittee, the PHS agencies appear to use the committee for 
exchange of information on blood safety issues on a bimonthly 
basis. The meeting is chaired by Assistant Secretary for Health 
Dr. Philip Lee and is attended by agency heads and their 
deputies as voting members. Additional PHS staff are included 
as required.\66\
---------------------------------------------------------------------------
    \66\ Ibid.
---------------------------------------------------------------------------
    The Advisory Council is scheduled to meet two times each 
year and have 18 voting members, as well as non-voting ex 
officio representatives of the PHS agencies.\67\
---------------------------------------------------------------------------
    \67\ Ibid.
---------------------------------------------------------------------------

4. The public is provided insufficient information on the risks of 
        blood and blood products

    Federal, State and local public health officials, as well 
as physicians and other health care providers, must evaluate 
the inevitable risks in the use of blood and blood-derived 
therapies. Those risks, however small, must then be 
communicated to patients in time, and in a form, to be useful 
in their consideration of alternative, less risky, treatment 
options.
    Dr. John A. Penner, a professor of medicine and pathology 
at Michigan State University, testified that the ``public has 
long enjoyed the sense that blood provided through the best of 
intentions by volunteers, their neighbors in the communities, 
is not only life-saving but essentially risk-free. . . . 
Although the public and health care workers have been 
disillusioned by events over the past 15 years, they still 
unrealistically expect and demand complete, safe, and risk-free 
blood and blood products.'' \68\
---------------------------------------------------------------------------
    \68\ Testimony of Dr. John Penner, HRIR hearings, p. 48.
---------------------------------------------------------------------------
    He believes that physicians have also left the burden of 
knowledgeable use of blood products to others and have avoided 
careful evaluation of these products.\69\ Dr. Penner feels that 
transfusion education is critically needed by most physicians. 
He conducted a study, funded by NIH, which attempted to alter 
physician practices in relation to the use of blood products. 
While physicians decreased the number of blood products 
transfused, they failed to improve ``the appropriateness of 
their ordering practices and often administered concentrates 
unnecessarily when platelet levels were decreased, but not to a 
degree that would require support'' with blood products.\70\ He 
concluded that ``a strong educational program with frequent 
reinforcement will be needed before any significant reduction 
in inappropriate use can be obtained.'' \71\
---------------------------------------------------------------------------
    \69\ Ibid.
    \70\ J.A. Penner, R.G. Brigham, Intervention/Education to Improve 
Hemostatic Product Use, Final Progress Report for National Heart, Lung 
& Blood Institute, Grant #HL33922-05, submitted 2/92.
    \71\ Testimony of John Penner, M.D., HRIR hearings, p. 52.
---------------------------------------------------------------------------
    According to testimony, the degree to which a patient is 
informed of the risks associated with blood products also 
varies from geographic location and from physician to 
physician.\72\ For three decades, the risk of contracting 
Hepatitis was considered a medically acceptable risk with 
regard to use of blood and blood products.\73\ If Hepatitis had 
not been tolerated as a medically acceptable risk, available 
technologies to kill Hepatitis virus could have also killed the 
unknown HIV present in the blood supply, greatly reducing the 
exposure of blood product users to HIV.\74\
---------------------------------------------------------------------------
    \72\ Patricia De Filippi, HRIR hearings, p. 65.
    \73\ Statement of Corey Dubin, HRIR hearings, p. 40.
    \74\ Ibid, p. 44; and IOM Report, p. 93-94.
---------------------------------------------------------------------------
    Patients have a number of autologous (self-donation) 
options to reduce use of donated and pooled blood products. 
These options include: preoperative donation of blood products, 
intraoperative salvage of red blood cells, postoperative 
salvage of blood from surgical wound drainage.\75\ It appears 
that, little, if any information, is routinely provided to 
patients regarding these options.
---------------------------------------------------------------------------
    \75\ Statement of Ronald Gilcher, M.D., HRIR hearings, p. 59.
---------------------------------------------------------------------------

5. The FDA has not effectively managed regulatory review of blood 
        issues, particularly its advisory committee on blood safety 
        issues, the Blood Products Advisory Committee (BPAC)

    A test for HCV became available for screening blood donors 
in 1990. At that time, an estimated 300,000 persons were still 
alive who had been infected through blood products and were 
unaware of their infection. Treatment options were available. 
The FDA's BPAC considered whether patients who received the HCV 
infected units should be notified of their exposure on all of 
the following dates: Oct. 31, 1989; Jan. 17-18, 1991; Sept. 26-
27, 1991; March 12-13, 1992; March 25-26, 1993; Dec. 2-3, 1993; 
and Dec. 15-16, 1994.\76\ However, the BPAC has not taken 
action on this issue.
---------------------------------------------------------------------------
    \76\ BPAC minutes (in subcommittee files).
---------------------------------------------------------------------------
    Nevertheless, Subcommittee Chairman Shays received a 
commitment from Secretary Shalala and Assistant Secretary for 
Health Philip Lee at the October 12th hearing that HCV 
notification would be the first issue considered by the new 
Advisory Council on Blood Safety and Availability.\77\
---------------------------------------------------------------------------
    \77\ Testimony of Dr. Lee, HRIR hearings, p. 29-30.
---------------------------------------------------------------------------
    In another area, the BPAC again failed to reach a final 
decision on an important public health issue. In March 1994, 
the National Hemophilia Foundation (NHF) recommended to BPAC 
that manufacturers of plasma products update their product 
package inserts to include the risks of Parvovirus B19 and 
Hepatitis A attendant to use of these products. The issue was 
again considered in March 1996 but no decision was ever made. 
The National Hemophilia Foundation believes that specific 
warnings of possible infectious disease transmission via 
clotting factor concentrates, although needed to ensure 
informed treatment decisions, are not on the package insert 
because the BPAC has been unable to make a decision on the 
matter.\78\
---------------------------------------------------------------------------
    \78\ National Hemophilia Foundation's June 6, 1996 correspondence 
with HRIR Subcommittee (in subcommittee files).
---------------------------------------------------------------------------
    According to testimony, FDA is also not working effectively 
with manufacturers to expedite the development of new screening 
tests and viral inactivation techniques for blood product 
sterilization.\79\ One manufacturer submitted a 510(k) \80\ 
application for a Chagas' disease screening test as a medical 
device to FDA's Center for Devices and Radiological Health 
(CDRH), at the suggestion of FDA in November 1995. The company 
had already received approval of a 510(k) for diagnostic 
testing in 1994. In November 1995, FDA informed the company 
that the screening indication required filing a Product 
Licensing Application (PLA) with the Center for Biologics 
Evaluation and Research (CBER). As a result of this confused 
regulatory system, to date there is still no approved Chagas 
disease screening test for donated blood and plasma.
---------------------------------------------------------------------------
    \79\ Statement of Patricia De Filippi, National Hemophilia 
Foundation, p. 40.
    \80\ Section 510 of the Federal Food, Drug, and Cosmetic Act 
requires the filing of a premarket notification by a manufacturer prior 
to initial marketing of a device or prior to marketing a device with a 
new intended use, or a modified device (42 Fed. Reg. 42,520, 42,528 
(1977); 21 C.F.R. 807.81.
---------------------------------------------------------------------------
    Questions have also been raised by consumer groups about 
the agency's selection of agenda items for BPAC meetings, 
drafting of questions which must be voted upon after BPAC 
deliberation, the comprehensiveness and impartiality of the 
background information FDA sends to committee members, and the 
criteria used to select BPAC members.\81\
---------------------------------------------------------------------------
    \81\ Response of the National Hemophilia Foundation to the Task 
Force on Blood Safety Report, HRIR hearings, p. 80; and July 2, 1996 
letter of complaint about BPAC from Keith Waterbrook, director of 
Health Services, Jeffrey Goodman Special Care Clinic, Los Angeles, CA 
to Subcommittee Chairman Christopher Shays (in subcommittee files).
---------------------------------------------------------------------------
    According to NHF, the FDA's policies and procedures for 
BPAC structure, organization, and the methods used for making 
decisions regarding its membership are tightly controlled by 
agency officials.\82\ After the reorganization of the BPAC in 
the Fall of 1995, the HRIR Subcommittee discovered that only 
one of the current BPAC members was nominated by individuals or 
organizations outside FDA. In fact, FDA officials chose at 
least one individual now serving on the BPAC who was not 
nominated to represent an organization over other equally 
qualified individuals who had been nominated by that very 
organization.\83\
---------------------------------------------------------------------------
    \82\ Response of the National Hemophilia Foundation to the Task 
Force on Blood Safety Report, HRIR hearings, p. 80.
    \83\ BPAC nomination documents delivered to HRIR Subcommittee on 
Feb. 20, 1996 in response to Feb. 1, 1996 HRIR Subcommittee document 
request (in subcommittee files).
---------------------------------------------------------------------------
    There are a number of critical sectors, such as consumers 
who are heavy users of blood products and their treating 
physicians, which believe they have not had and still do not 
have input into blood policy decisions at the Federal 
level.\84\ The National Hemophilia Foundation feels that FDA 
has not been open to consumer participation in blood safety 
policy areas.\85\ One hemophiliac consumer, who is also a 
physician, was added to the BPAC in 1994. A second consumer was 
added to the committee in 1995. In 1996, there are only two 
voting consumers and one non-voting consumer on the BPAC, which 
has 17 members.
---------------------------------------------------------------------------
    \84\ Statement of Dr. John Penner, HRIR hearings, p. 52.; statement 
of Patricia De Filippi, HRIR hearings, p. 40; statement of Corey Dubin, 
HRIR hearings, p. 46; and statement of Dr. Ronald Gilcher, HRIR 
hearings, p. 58.
    \85\ Response for the record of the National Hemophilia Foundation 
to the Task Force on Blood Safety Report, HRIR hearings, p. 77.
---------------------------------------------------------------------------
    Representative Porter Goss (R-FL) has introduced a bill 
H.R. 1021, ``The Blood Products Advisory Committee Act of 
1995'' to require at least one-third of BPAC voting members to 
be consumers. He believes this bill will ``rearrange what was 
clearly a conflict of interest, a too-close-for-comfort 
situation, between people who were making the decisions about 
protecting the blood supply and the people who were producing 
the products that were being used.'' \86\
---------------------------------------------------------------------------
    \86\ Testimony of Representative Porter Goss, HRIR hearings, p. 31.
---------------------------------------------------------------------------
    In addition, testimony indicates that the failure by FDA to 
appoint treating physicians to the BPAC results in the absence 
of a critical perspective of medical professionals treating 
heavy consumers of blood products. As a result, treating 
physicians have not been able to educate their patients and the 
public about the risks and benefits of blood products.\87\
---------------------------------------------------------------------------
    \87\ Statement of John Penner, M.D., HRIR hearings, p. 52.
---------------------------------------------------------------------------
    On three occasions recently, FDA acknowledged problems in 
the operation of the BPAC.
    The FDA went around the BPAC and sought regulatory advice 
from an ad hoc committee on CJD in 1995.
    FDA's BPAC first met to discuss the potential risk of CJD 
transmission through blood in December 1994, voting 14 to 1 in 
favor of withdrawing blood components collected from donors who 
subsequently developed CJD. But calling the CJD risk 
theoretical and expressing concern about possibly creating 
shortages of plasma products, the committee voted against the 
recall of plasma derivatives despite impassioned pleas from 
hemophiliac representatives. BPAC voted 9 to 4 in favor of 
indefinite lookback \88\ and informing recipients of blood 
components from blood donors who subsequently developed CJD. 
However, the committee voted 10 to 4 against such notification 
of plasma derivative recipients.
---------------------------------------------------------------------------
    \88\ Locating the recipients of infected blood after they have been 
transfused.
---------------------------------------------------------------------------
    On June 22, 1995 FDA convened the ad hoc Special Advisory 
Panel on CJD. The panel endorsed the recommendations made at 
BPAC's December 1994 meeting to recall blood components made 
from blood donors who developed CJD and to notify recipients. 
However, the panel also recommended withdrawal of plasma 
derivatives from plasma donors who subsequently developed CJD 
and notification of recipients of these products.
    In August 1995 FDA Commissioner Kessler asked 11 of the 13 
members of the BPAC to resign due to perceived potential 
conflicts of interest involving their employment in regulated 
establishments such as hospital blood banks and regional blood 
centers. The Commissioner's action followed much criticized 
BPAC decisions on CJD and p24 antigen testing.\89\
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    \89\ See recommendation 6.
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    In addition, the subcommittee has learned that the FDA does 
not manage its inspection responsibilities for the blood 
industry in the same manner as the agency approaches other 
regulated industries. The agency requests production schedules 
from some plasma fractionation companies prior to scheduling 
annual or biennial domestic biologic establishment inspections. 
The request for production schedules would serve to notify a 
firm of an impending inspection. Except in exceptional 
circumstances, FDA operates on a system of unannounced 
inspections of all other regulated industries.\90\
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    \90\ FDA briefing with HRIR Subcommittee staff, May 24, 1996 (notes 
in subcommittee files). See also FDA Field Management Directive, 3/4/
88.
---------------------------------------------------------------------------
    In FY 95, FDA's CBER personnel performed 47 inspections. 
Production schedules were requested from one manufacturer for a 
period of less than 3 months; from nine manufacturers for a 
period of 3 to 6 months; from two manufacturers for a period of 
1 year and four manufacturers were asked for production 
schedules of unknown duration. In FY 95, CBER performed a total 
of six annual/biennial inspections of domestic plasma 
derivative manufacturers and requested production schedules for 
3 to 6 months for two inspections.\91\ Furthermore, FDA does 
not maintain records of these requests for production schedules 
and was unable to provide a complete assessment of this 
practice to the subcommittee staff.
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    \91\ June 3, 1996 FDA document delivery to HRIR Subcommittee (in 
subcommittee files).
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6. Despite a BPAC recommendation to the contrary, the FDA took the 
        first step toward closing the ``window period'' of possible HIV 
        transmission by licensing the p24 antigen test for screening of 
        donated blood

    After infection with HIV, there is a period of time known 
as a ``window'' in which infection may be present but 
antibodies to the virus have not yet been produced in 
sufficient quantity to be detected by blood screening tests. 
This window can last up to 6 months in some individuals, but is 
usually about 20 days. Antigens appear and can be detected 
sooner than antibodies, reducing the window by 10 days or more.
    Reduction of the window period by 10 days is estimated to 
result in detection of up to 20 infected (antigen positive/
antibody negative) donation cases per year which would be 
missed using only the antibody tests. Since each donation 
collected undergoes separation into at least two units, antigen 
testing could prevent up to 40 individuals from exposure to 
HIV-tainted blood products each year. That in turn could 
prevent transmission via sexual contact or other high-risk 
behavior to an additional estimated 1.7 individuals per 
infected recipient. As a result, at least 68 individuals per 
year could be protected from HIV infection through licensing of 
antigen tests as a screening tool.
    On June 23, 1995, the FDA's Blood Products Advisory 
Committee (BPAC) recommended against routine HIV-1 antigen 
screening of blood donor units. At the October 12th hearing, 
Corey Dubin, a voting member of BPAC at the time, described the 
BPAC deliberation process on antigen testing as a ``discussion 
centered on whether this was the best expenditure of the 
shrinking monies for AIDS. The BPAC, dominated by blood 
bankers, was clearly in violation of its mandate regarding the 
safety of the blood supply. I do not believe that it is the job 
of the FDA and its BPAC to be considering how AIDS dollars are 
spent and then basing what should be a purely safety driven 
decision on that economic analysis.'' \92\
---------------------------------------------------------------------------
    \92\ Statement of Corey Dubin, HRIR hearings, p. 45.
---------------------------------------------------------------------------
    On July 12, 1995 Subcommittee Chairman Shays wrote to FDA 
Commissioner David A. Kessler urging him not to accept the 
BPAC's decision but to approve the immediate licensing of HIV-1 
antigen tests for the screening of the Nation's blood supply.
    Shays pointed out that antigen testing would further close 
the window of potential infection in recipients of blood and 
blood products, a goal which was consistent with remarks made 
by Commissioner Kessler at a September 26, 1994 NIH conference. 
Dr. Kessler said he believed that as a public health agency the 
FDA has ``an obligation to foster the development of new 
technologies, especially if these technologies hold the promise 
of a blood supply that is even safer. This is especially true 
for detecting HIV--the AIDS virus. We need to close the 
window.'' \93\
---------------------------------------------------------------------------
    \93\ September 26, 1994 NIH Conference on the Feasibility of 
Genetic Technology to Close the HIV Window in Donor Screening.
---------------------------------------------------------------------------
    Subcommittee Chairman Shays was also concerned that failure 
to license antigen testing for donor screening would make it 
unlikely that any company would pursue RNA technology which 
could close the window completely within 5 years. On August 8, 
1995 Dr. Kessler announced FDA guidance to industry 
recommending use of the new p24 antigen screening kits within 
90 days of the first kit's licensure by FDA.\94\
---------------------------------------------------------------------------
    \94\ August 8, 1995 CBER memo to all registered blood and plasma 
establishments.
---------------------------------------------------------------------------
    Also in August 1995, FDA requested the resignations of most 
of the BPAC members who were affiliated with regulated entities 
such as hospital blood banks. FDA did not however, increase the 
voting role of consumers most affected by blood safety 
decisions.
    The Product Licensing Applications (PLAs) for the short 
duration p24 HIV-1 antigen tests were filed in 1990 but not 
approved until 1996.

7. Fifteen years after the AIDS virus emerged as a threat to the blood 
        supply, FDA still has not developed an effective system for 
        communicating blood product recalls or viral outbreaks to 
        pharmacists, doctors or patients

    FDA has the authority to request a manufacturer to recall a 
product if it poses a risk to public health.\95\ Failure by a 
manufacturer to voluntarily recall a product when requested to 
do so by FDA can result in the seizure of the violative product 
and or suspension of the manufacturer's license. That in turn 
could shut down the manufacturer's operations and destroy 
public confidence in the product, damaging the market for the 
product.
---------------------------------------------------------------------------
    \95\ 21 C.F.R. 7.11.
---------------------------------------------------------------------------
    FDA regulations require that manufacturers of recalled 
products notify each of the firm's ``directed accounts'' about 
the recall. The regulation doesn't define ``accounts'' and 
states that ``where appropriate . . . the direct account should 
in turn notify its customers who received the product about the 
recall.'' \96\
---------------------------------------------------------------------------
    \96\ 21 C.F.R. 7.49; presentation of Glenn Pierce, M.D., National 
Hemophilia Foundation, to BPAC, March 15, 1996 (in subcommittee files); 
and HRIR Subcommittee conference call with FDA CBER personnel, July 17, 
1996 (notes in subcommittee files).
---------------------------------------------------------------------------
    Even when the provider of the recalled product notifies a 
patient of the recall, the notification of the patient by the 
manufacturers and treating hospitals varies a great deal. 
Patricia De Filippi, the parent of a hemophiliac, testified 
that the medical center providing a recalled product did not 
inform her for 6 months of the recall, during which time her 
son consumed a 6 month supply of the recalled product in home 
therapy.\97\
---------------------------------------------------------------------------
    \97\ Statement of Patricia De Filippi, p. 38.
---------------------------------------------------------------------------
    In addition to notification of consumers and providers of 
contaminated products, there are also disputes about 
nomenclature used for market withdrawal and recall 
notification. The term ``field exchange'' has been used by 
plasma concentrate manufacturers to describe actions referred 
to as recalls by the FDA in its enforcement report.\98\ Terms 
such as field exchange have no basis in statute or in FDA 
regulations, yet the agency has apparently permitted 
manufacturers of biologic products to utilize these terms in a 
practice for biological products that is not permitted for 
drugs, devices or foods.
---------------------------------------------------------------------------
    \98\ FDA January 16, 1996 Talk Paper ``Factor VIII and Factor IX 
Products Associated with Hepatitis A Transmission,'' and NHF March 11, 
1996 press release ``Alpha Therapeutic Corporation Conducts `Field 
Exchange' of Lots of Alphanine SD . . . Due to Possible Transmission of 
Hepatitis A Virus.''
---------------------------------------------------------------------------

8. The size of plasma pools for fractionated products can increase the 
        risk of infectious disease transmission

    In the United States, there are over 400 FDA-licensed 
plasma collection facilities and 5 principal pharmaceutical 
firms engaged in plasma fractionation.\99\ U.S. plasma 
collection facilities conduct approximately 13 million 
plasmapheresis collection procedures annually and provide 60 
percent of the world's need for plasma.\100\ Plasmapheresis, a 
method of collecting plasma from the donor instead of whole 
blood, increases the plasma yield from each donor and can 
reduce the number of donors in each pool of plasma from which 
products are manufactured.\101\
---------------------------------------------------------------------------
    \99\ Plasma fractionation is the separation of plasma into its 
major proteins. Since the production of antihemophilic factor (a.k.a. 
clotting factor concentrates) requires donations from thousands of 
donors, these donations are pooled into a large batch for further 
processing. IOM Report, p. 311.
    \100\ Testimony of James Reilly, American Blood Resources 
Association, HRIR hearings, p. 181-182.
    \101\ Testimony of Dr. Bruce Evatt, CDC, HRIR hearings, p. 117.
---------------------------------------------------------------------------
    Source plasma is the non cellular fluid portion of blood 
that is used as a raw material in the production of plasma-
based therapies. These products are used in the treatment and 
diagnosis of conditions such as cardiac surgery, immune 
disorders, hemophilia, burns, trauma, and to provide protection 
against Hepatitis B, Rh disease and tetanus.
    These products are made with the pooled plasma of up to 
60,000 \102\ people for some products. Some potential donors 
have HIV, Hepatitis and other infectious diseases. Therefore, 
manufacturers attempt to reduce the viral load of the initial 
plasma prior to manufacturing, creating a greater safety 
margin.\103\
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    \102\ HRIR conference call with FDA CBER personnel, July 17, 1996 
(notes in subcommittee files).
    \103\ Testimony of Dr. Thomas Waytes, Immuno-U.S., HRIR hearings, 
p. 226.
---------------------------------------------------------------------------
    But some virus gets through the donor screening process, 
and viral inactivation procedures such as heat treatments, 
pasteurization and solvent detergents are used in an effort to 
kill the remaining viruses in the pool.
    Therefore, donor pool size is equivalent to risk. Reduction 
in pool size reduces the number of donors to which a recipient 
of fractionated products is exposed. The fewer the donors to 
which a recipient is exposed, the less the risk.\104\
---------------------------------------------------------------------------
    \104\ Testimony of Dr. Bruce Evatt, CDC, HRIR hearings, p. 119.
---------------------------------------------------------------------------
    First time donors present the greatest risk to the plasma 
and blood supply. Ninety-five percent of plasma donations which 
test positive for HIV or Hepatitis B or C come from first time 
donors who do not return to make a second donation within 3 
months.\105\
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    \105\ Testimony of Mark Phillip, Immuno, HRIR hearings, p. 216.
---------------------------------------------------------------------------
    Some companies have used this information to develop 
manufacturing approaches to enhance the safety of pooled plasma 
products. In 1994, Immuno-U.S. (``Immuno''), a producer of 
plasma products, established a first-time donor applicant 
rejection system. Under this policy, the company destroys all 
plasma from first time donors who do not return to make a 
second donation within 3 months and undergo a second round of 
viral testing. This eliminates the chance that a donor in the 
window period of hepatitis or HIV infection is donating only 
for the screening test results.
    Immuno has also instituted an inventory hold for 3 months 
in which units of plasma from first time donors which have been 
screened and found suitable for production are placed on hold 
for 90 days. If the donor is found to be reactive to screening 
tests on a subsequent donation or if the donor does not return 
to donate again with the 90 day period, the previous plasma is 
destroyed. This is to eliminate the possibility of a window 
case of Hepatitis or HIV, where the donor may have donated only 
to get tested for an infectious agent. Ninety-seven percent of 
plasma units collected by Immuno are followed by at least one 
additional donation by the same donor and thus have the benefit 
of this inventory hold follow-up.\106\
---------------------------------------------------------------------------
    \106\ Testimony of Dr. Mark Philip, Immuno-U.S., HRIR hearings, p. 
219.
---------------------------------------------------------------------------
    Immuno reports that as a result of the 3-month inventory 
hold, the company removed and destroyed 8 times more 
potentially risky plasma than would have been removed without 
the benefit of this program. The inventory hold program results 
in removal and destruction of almost 1% of the plasma collected 
by Immuno which otherwise would be acceptable for use by FDA 
standards. However, this has resulted in greater costs of 
production.\107\
---------------------------------------------------------------------------
    \107\ Testimony of Dr. Mark Philip, Immuno-U.S., HRIR hearings, p. 
217.
---------------------------------------------------------------------------
    The fewer donations from individual donors that go into a 
plasma pool,\108\ the safer that pool will be.\109\ In 
addition, viral load has been reduced by companies \110\ which 
locate centers in pleasant and supportive environments, with 
child care. These provisions in turn encourage frequent, 
regular donation by desirable, low-risk donors in communities 
with low incidence of infectious disease.
---------------------------------------------------------------------------
    \108\ Through utilization of repeat donors, where the donors are 
clearly identified and monitored very closely.
    \109\ Testimony of Dr. Bruce Evatt, CDC, HRIR hearings, p. 117.
    \110\ Immuno testified that the company has seen an 88% decrease 
the last 5 years in viral marker rates for HIV among the donor 
population, with similar rate reductions for Hepatitis B and C. 
Testimony of Dr. Mark Philip, Immuno-U.S., HRIR hearings, p. 215.
---------------------------------------------------------------------------

                          IV. Recommendations

1. Congress should establish the Blood Safety Committee and the 
        Advisory Committee on Blood Safety and Availability in statute

    The IOM Report states that the Blood Safety Director should 
be at the level of a deputy assistant secretary or higher, and 
should not be a representative of any single PHS agency in 
order to be effective in coordinating the various agencies of 
the PHS. The Clinton administration's appointment of the 
Assistant Secretary for Health as the Blood Safety Director 
would not obligate this or any future administration to 
maintain this structure or continue to implement the IOM 
recommendations.
    The roles and responsibilities of the Blood Safety Council, 
National Advisory Committee and the BPAC should be defined 
clearly to ensure greater coordination and to ensure that the 
BPAC confines its decisions to scientific matters under the 
jurisdiction of FDA.

2. Congress should consider establishing an indemnification system for 
        individuals who suffer adverse consequences from the use of 
        blood and blood products \111\
---------------------------------------------------------------------------

    \111\ Statement of Secretary Shalala, HRIR hearings, p. 17.
---------------------------------------------------------------------------
    Potential injury from blood, blood products, and blood 
derivatives continues to be a reality for all people who must 
use these products in the course of medical treatment. Since 
1985, clotting factor products have been treated with viral 
inactivation measures which have virtually eliminated the 
threat of HIV.
    Blood components from individual donors, however, are not 
virally inactivated and may transmit infectious diseases. Since 
it is impossible to make the blood 100 percent safe, society 
needs to examine effective avenues for compensating those 
parties who will be injured as result of the inherent 
imperfections in the blood supply, however small, including 
alternative dispute mechanisms and no-fault compensation 
programs as a means to achieve better and more efficient 
resolutions of claims resulting from transfusion-related 
injuries.
    The solution may be the enactment of a blood and blood 
products compensation trust fund that would give consumers 
needed recourse in most legal settings.\112\ Since blood borne 
pathogens take years to manifest harm, not only do individuals 
have to overcome State blood shield laws,\113\ but statutes of 
limitations as well.
---------------------------------------------------------------------------
    \112\ IOM Report, p. 13.
    \113\ The blood shield laws were enacted by 47 States in the 1950's 
and 1960's to exempt blood and blood products from ``strict liability 
or implied warranty claims on the basis that blood and blood products 
provide a service, not a sale.'' IOM Report, p. 49.
---------------------------------------------------------------------------
    Experience to date suggests that development of such a 
program involves resolution of many complex issues, including 
development of sufficient funding mechanisms and obtaining the 
cooperation of both Government and private insurers to support 
an alternative to the traditional tort system, such as the 
National Vaccine Compensation Program.\114\
---------------------------------------------------------------------------
    \114\ Statement of Karen Shoos Lipton, HRIR hearings, p. 131; 
statement of Dr. Toby Simon, HRIR hearings, p. 140.
---------------------------------------------------------------------------

3. HHS should take steps to ensure that the estimated 300,000 living 
        recipients of blood and blood products who were infected with 
        Hepatitis C virus before 1990 are notified of their potential 
        infection so that they might seek diagnosis and treatment

    Dr. Lee and Secretary Shalala agreed at the October 12 
hearing to place the HCV notification issue first on the agenda 
of the Blood Safety Committee.\115\ The Blood Safety Committee 
has met bimonthly since December 1995 but no public statements 
have been made on this issue.
---------------------------------------------------------------------------
    \115\ Testimony of Dr. Philip Lee and Secretary Shalala, HRIR 
hearings, p. 29-30.
---------------------------------------------------------------------------
    HHS has informed the subcommittee staff that the Blood 
Safety Committee has approved but not yet implemented an 
outreach plan to medical providers that will identify patients 
at risk and provide testing, treatment and counseling 
recommendations. The committee will also identify a model for 
outreach to affected consumers who would not be in regular 
contact with a medical provider.\116\
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    \116\ HRIR Subcommittee staff meeting with Marc Smolonsky, Office 
of the HHS Assistant Secretary for Legislation, June 4, 1996 and 
conference call of June 5, 1996 (notes in subcommittee files).
---------------------------------------------------------------------------

4. HHS should disseminate more clinically useful information to 
        providers of care and to the public regarding blood safety 
        issues

    Recommendation 13 of the IOM report states that, ``The 
Department of Health and Human Services should convene an 
expert panel to inform the providers of care and the public 
about the risks associated with blood and blood products, about 
alternatives to using them, and about treatments that have the 
support of the scientific record.'' \117\
---------------------------------------------------------------------------
    \117\ IOM Report, p. 232.
---------------------------------------------------------------------------
    The HHS' Secretary's Task Force agreed: ``that this type of 
clinically useful information should be communicated as it 
becomes available. As issues of importance arise, the PHS Blood 
Safety Committee and the Advisory Council on Blood Safety and 
Availability will evaluate the government's communications 
efforts, including the activities of the Agency for Health Care 
Policy and Research and its clinical guidelines program, to 
determine what additional efforts are needed.'' \118\
---------------------------------------------------------------------------
    \118\ Report to the Secretary--Task Force on Blood Safety, HRIR 
hearings, p. 21.
---------------------------------------------------------------------------
    HHS should develop a standardized informed consent document 
to be given to patients prior to transfusion, outlining the 
risks and benefits of blood and blood product transfusion.\119\ 
Patients should be made aware of all options to reduce use of 
donated and pooled blood products, as well as other non-blood 
based products such as recombinant products which would reduce 
the risk of transmitting blood borne pathogens.
---------------------------------------------------------------------------
    \119\ Statement of Patricia De Filippi, p. 40; testimony of Dr. 
John Penner, p. 48-49.
---------------------------------------------------------------------------
    In addition, FDA should promptly require plasma 
fractionators to provide adequate and appropriately updated 
warning labels for plasma products to ensure that patients are 
informed of the risks to which they may be exposed through use 
of these products, whether or not the BPAC is able to reach 
consensus on this matter.
    FDA should also work with plasma fractionators to develop 
appropriate labeling to include von Willebrand \120\ disease 
indications for intermediate purity hemophilia products 
developed for hemophilia treatment. These hemophilia products 
are currently used off-label for treatment of severe von 
Willebrand disease.
---------------------------------------------------------------------------
    \120\ An inherited bleeding disorder affecting 500,000 persons in 
the United States (half of whom are women) caused by absent or 
insufficient levels of glycoprotein in the blood. March 5, 1996 letter 
from National Hemophilia Foundation President Stephen Bajardi to 
Subcommittee Chairman Shays (in subcommittee files).
---------------------------------------------------------------------------
    Dr. John Penner testified that ``most of the patients with 
severe von Willebrand disease are receiving these products as 
their only means of controlling hemorrhagic episodes. In my 
practice, I allow surgery to be performed on such patients, 
despite the fact that I am unsure of the quality and the 
content of the product that I have ordered. The potential for 
serious complications exists under these conditions and surely 
requires a solution that must be addressed by the FDA.'' \121\
---------------------------------------------------------------------------
    \121\ Statement of Dr. John Penner, HRIR hearings, p. 53; and March 
5, 1996 letter from National Hemophilia Foundation President Stephen 
Bajardi to Subcommittee Chairman Shays (in subcommittee files).
---------------------------------------------------------------------------

5. FDA should immediately develop an effective system of recall 
        notification for blood and plasma products

    A system should be developed and enforced by FDA for 
notifying consumers and health care providers about potential 
threats to blood products from infectious diseases, not only 
manufacturers' directed accounts. An effective recall system 
would require manufacturers undertaking voluntary withdrawals 
and recalls to utilize consistent language for these 
procedures, so that the impact on directed accounts and 
consumers is fully realized.
    An effective recall communication system would ensure that 
consumers, as well as manufacturers directed accounts, are 
promptly advised of identified hazardous products in order that 
they may discontinue use and reduce their risks of exposure.

6. FDA should immediately cease its practice of providing advance 
        notice of safety and compliance inspections to some plasma 
        fractionators

    This practice is inconsistent with FDA's inspection 
practices for other industries regulated by FDA.\122\ It is 
used only by the CBER officials on a joint inspection with FDA 
Office of Regulatory Affairs \123\ personnel (ORA), only in 
some cases, and is not documented when used. This practice may 
appear to companies as favoritism for competing firms and could 
affect consumer and industry confidence in the agency's 
enforcement practices.
---------------------------------------------------------------------------
    \122\ HRIR Subcommittee interview with FDA, May 24, 1996 (notes in 
subcommittee files).
    \123\ FDA field inspection personnel.
---------------------------------------------------------------------------

7. Plasma fractionators should limit the size of plasma pools, with 
        pool sizes determined as much by public health risk factors as 
        by production economies of scale

    The IOM report stated that ``reducing risks by smaller 
pools would not eliminate risk. Indeed, a substantial pool is 
necessary to assure the efficacy of some plasma derivatives and 
reduce certain risks in others. But maintaining these levels 
could be accomplished while reducing pool sizes by a factor of 
20. The critical point to this example is that because FDA 
promoted no changes in pooling practices, it faces in 1995 the 
same dilemma concerning Creutzfeldt-Jakob disease that it faced 
in 1983-84 concerning AIDS.'' \124\
---------------------------------------------------------------------------
    \124\ IOM Report, p. 165 and p. 222.
---------------------------------------------------------------------------
    A reduction in plasma pool size could make product recalls 
easier and also minimize the potentially disruptive effect of 
product withdrawal and recalls on supply of plasma 
products.\125\
---------------------------------------------------------------------------
    \125\ Testimony of Dr. Thomas Waytes, Immuno-U.S., HRIR hearings, 
p. 224.
              ADDITIONAL VIEWS OF HON. CAROLYN B. MALONEY

    I applaud the Subcommittee on Human Resources and 
Intergovernmental Relations for its in-depth report entitled 
``Protecting the Nation's Blood Supply from Infectious Agents: 
The Need for New Standards to Meet New Threats.'' Chairman 
Shays and ranking Democrat Ed Towns have done an outstanding 
job on the series of hearings held in the Fall of 1995 and in 
the preparation of the report.
    The report raises important and complex scientific, public 
health and safety issues. It is heartening, indeed, that the 
committee has found that the Nation's blood supply is safer 
than it has ever been. This is due in no small measure to the 
cooperation of government regulators and the Nation's blood 
suppliers and blood derivative manufacturers. At the same time 
we all agree that safety is an important concern and continued 
vigilance is necessary. With more HIV-infected people than any 
other state--20% of the Nation's total AIDS cases--the safety 
of our Nation's blood supply is of critical importance to my 
constituents in New York.
    The report urges the Congress to consider establishing an 
indemnification system for individuals who suffer adverse 
consequences from the use of blood and blood derivatives. While 
I agree that Congress should continue to review the underlying 
causes that produce such a recommendation, it does not appear 
that the hearing records support the suggestion that the 
National Vaccine Compensation Program (NVCP) be used as a model 
for such a system. It does not appear that the true costs of 
such a ``prospective'' system have been calculated and weighed. 
The additional costs imposed on vaccine products for the NVCP 
are spread over millions of users for products that are 
themselves modest in cost. Coverage of blood and blood 
derivatives with such a system, considering the vastly smaller 
user population, could result in substantial additional costs 
being passed through to users. This could result in fewer 
hemophiliacs and other chronic disease sufferers being able to 
afford these life-giving and lifesaving products and therapies. 
The alternative would seem to be the use of a taxpayer funded 
initiative which would give us all some pause. This issue 
should be given further consideration before Congress takes any 
legislative action.
    Again, I applaud the subcommittee for its work in this 
area. I agree that we must remain vigilant in our efforts to 
insure the safety of our Nation's blood supply and look forward 
to working with the subcommittee in the years ahead to pursue 
this shared goal.

                                   - 
