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Blood Safety Summary - April 1998
DATE: July 23, 1998
TO: Interested Parties
FROM: Stephen D. Nightingale, MD, Executive Secretary Advisory Committee on Blood Safety and Availability V
SUBJECT: Summary of the Advisory Committee on Blood Safety and Availability Meeting on April 27 and 28, 1998
The Advisory Committee on Blood Safety and Availability met on April 27 and
28, 1998 at the Holiday Inn Georgetown, 2101 Wisconsin Ave. NW, Washington,
DC 20007. The agenda of the meeting was to consider what had caused the current
shortages of plasma derivatives and what could be done to correct this situation.
Members present were Dr. Arthur Caplan, Chairman; Mr. Larry Allen, Dr. James
AuBuchon, Dr. Michael Busch, Dr. Ronald Gilcher, Dr. Edward Gomperts, Dr.
Fernando Guerra, Dr. Paul Haas, Dr. Keith Hoots, Dr. Dana. Kuhn, Ms. Carolyn
Jones, Dr. John Penner, Dr. Jane Piliavin, Dr. Eugene Schiff, Dr. Marian Secundy,
and Mr. John Walsh. Ex officio members present were Dr. Mary Chamberland,
Dr. David Feigal, Dr. Eric Goosby, and Dr. Paul McCurdy. Also present were
Dr. Richard Davey, a consultant to the Committee, Dr. Stephen Nightingale,
the Executive Secretary, CDR Lawrence McMurtry, the Deputy Executive Secretary,
and approximately 200 members of the public.
The meeting was called to order at 8: 10 AM. After roll call, a statement
of the meeting's agenda, and announcements related to potential conflicts of interest, Dr. Goosby
addressed the Committee on behalf of Dr. David Satcher, the Assistant Secretary
for Health and Surgeon General. Dr. Goosby emphasized the importance of the
topic before the Committee, and updated the Committee on the responses of
the Department of Health and Human Services to the Committee's prior recommendations
regarding hepatitis C and Creutzfeldt-Jakob disease.
Dr. Jerry Winkelstein then reviewed the immunology relevant to the agenda
for the Committee. He described the three major inununoglobulin classes and
the mechanisms by which they protect the body; the primary (congenital) immune
deficiencies such as x-linked agammaglobulinemia or common variable immune
deficiency (primary hypogammaglobulinernia) and the secondary (acquired) immune
deficiencies such as those produced by cancer chemotherapy. He then described
the responses of representative patients (with x-linked aga.mmaglobulinen-iia,
AIDS, and chronic lymphocytic leukemia) to treatment with intravenous inimunoglobulin.
Dr. Winkelstein estimated that there were 20,000 to 40,000 patients, children
and adult, in the US with primary immunodeficiency disorders. In response
to a question from Dr. Caplan, Dr. Winkelstein suggested that increased consumer
demand for intravenous immunoglobulins could be due to increased numbers of
patients diagnosed with immune deficiencies, increased use of intravenous
immunoglobulins to treat diseases other than immune deficiencies for which
treatment was clearly beneficial, and increased use to treat diseases for
which the benefit of treatment was unproven.
Representatives of the immune Deficiency Foundation then presented their
perspective on the current shortage of intravenous immunoglobulin. Mr. John
Boyle presented the results of two surveys, one of patients and one of physicians,
in which 80% of patients and 90% of physicians reported difficulty obtaining
intravenous immunoglobulin within the last six months. Ms. Karen Gewurth and
Dr. Larry Tabor of Texas Children's Hospital then described the triage system
they had established at their institution to respond to the shortage of intravenous
immunoglobulins, which prioritized delivery to patients with immune deficiencies,
immune thrombocytopenic purpura, Kawasaki's disease, and Guillain-Barre syndrome,
which accounted for about 60% of use under triage conditions. The next category
was patients with lymphocytic leukemia and bone marrow transplants, patients
with AIDS, and patients with unique circumstances such as protein- losing
enteropathy. They noted that children with bone marrow transplants, lymphocytic
leukemia, HIV infection, systemic lupus, toxic shock syndrome, and prematurity
had been denied treatment with intravenous immunoglobulin. In response to
a question, Dr. Tabor was supportive of efforts to reach a national consensus
on prioritization of intravenous immunoglobulin use.
Dr. Roger Kobyashi then described similar problems with intravenous immunoglobulin
shortages in his practice in Omaha, Nebraska, as did Mr. Michael Grote, a
pharmacist with Corum Health Care. Ms. Miriam O'Day summarized the efforts
of the Immune Deficiency Foundation to
help patients locate intravenous immunoglobulin. Finally, Mr. Thomas Moran
presented the request of the Foundation to the Committee for an explanation
of the current shortage and for a plan for the solution to it. Discussion
following these presentations addressed spot prices of the product and whether
a decrease. in the number of telephone calls to hot lines or federal agencies
was indicative of an amelioration of the current shortage. Finally, in response
to a question from Dr. Davey, Dr. Winkelstein was not optimistic about the
short term prospect of gene therapy alleviating the need for intravenous immunoglobulin
among the immune deficient.
Dr. Karen Gervais then described the process used at Allina Health System
in Minnesota to ration intravenous immunoglobulin. The first phase was to
prioritize use by a combination of severity of illness and known benefit of
therapy; the second was to identify availability; and the third was to evaluate
this strategy based on ethical principles as enunciated in American Medical
Association guidelines. The effect of the process was to systematize distribution
of scarce products throughout this health care system; it was associated with
a 75% reduction in the use of intravenous immunoglobulin by this
health care system.
After a break, Mr. Cory Dubin of the Committee of Ten Thousand addressed
the immunoglobulin shortage issue from the perspective of the hemophilia community.
He rejected the inevitability of a tradeoff between safety and availability
of blood products. He suggested that if optimal pool size and donor populations
differed for different users of blood products (for example, high-titer donors
for specific antisera) that separate production lines would be appropriate.
He expressed specific concern about emerging infectious threats to the blood
supply, such as non-lipid enveloped viruses, that might in the future overcome
current safeguards, and he encouraged FDA to make stronger independent use
of the regulatory power invested in it to insure public confidence in the
FDAs capacity to respond to emerging infectious threats to blood safety, such
perhaps as mad cow disease, as they emerge.
Mr. Dubin then decried the limited amount of data on production of blood
products that was available to those who advise the government on these matters,
and the process by which societal costs of blood safety are disproportionately
borne by users of these products. Finally, Mr. Dubin emphasized the need for
coordination of separate government blood safety programs, and gave as examples
of this need both the surveillance of hemophiliacs for Creutzfeldt-Jakob disease
and the current immunoglobulin shortage. He concluded with a request that
the standard of care for hemophiliacs be "nudged" toward recombinant products.
In response to a question from Mr. Walsh, Mr. Dubin responded that "We, obviously,
want to move hemophilia as much as possible to recombinant. I dont think that
means we want to abandon the safety discussion but I think, for us, our best
risk position is on recombinant product."
Ms. Jan Hamilton of the Hemophilia Federation, who spoke next, also raised
the issue of pool size in relation to blood safety, and raised the question
of whether in the long run smaller pools might increase both safety and availability
of blood products. Ms. Hamilton questioned why there were shortages of intravenous
immunoglobulin in the United States but not in Europe or Japan, where the
prices paid for these products may be higher. Ms. Hamilton called for action
based on good science rather than political groups, and noted that organizations
such as hers relied on their medical and scientific consultants for advice
on how to counsel their constituents; she expressed the hope that regulatory
agencies could provide the same peace of mind for consumers of blood products
as the NORAD radar system did during the cold war. She urged consideration
of pure recombinant factors as a national standard for all clotting factor
used in hemophilia treatment, and she stressed that it was not the wish of
the hemophilia community to request standards that would be to the detriment
of any other treatment community.
Dr. Glen Pierce then spoke on behalf of the National Hemophilia Foundation.
He joined previous speakers in supporting the use of recombinant clotting
factors for treatment of hemophilia, and emphasized the importance of prophylaxis
as well as treatment in the management of bleeding disorders. He did not feel
that adequate data was publicly available to completely determine the causes
of the current immunoglobulin shortages, and he requested that it be made
available. Dr. Pierce also repeatedly expressed concern about pool size and
Creutzfeldt-Jacob disease as threats to the safety of plasma derivatives.
He cited continuing concerns within the hemophilia community about the cost
of care, residual human plasma derivatives in recombinant products, the development
of additional recombinant products to treat patients with clotting factor
inhibitors, and effective sterilization of all blood products.
In the following discussion, Dr. Caplan asked for comment on the presenters
request that blood policy decisions be based on science when, in the case
of Creutzfeldt-Jakob disease, the available science was perceived to be inconclusive,
and why pool size had persisted as an issue for so long a time. In response
to the former question, Mr. Dubin called for caution until the issue was resolved;
in response to the latter question, Ms. Hamilton called for more consumer
representation on groups that advised the government.
Dr. Richard Morgan then described prospects for gene therapy in hemophilia.
He described various viral vector systems that hold promise for transferring
new genetic material into cells, including retroviruses and adeno-associated
viruses, and mentioned encouraging studies in rodents and in dogs. Dr. Morgan
described some of his own work with oral delivery systems which transfect
gastrointestinal cells, and work on in situ repair of genetic sequences known
as "chimeroplasty". Dr. Morgan anticipated that many different approaches
would be necessary for gene therapy of different conditions. He concluded
by summarizing preliminary human trials scheduled for initiation later this
year, but he cautioned that development of them would take at least five years.
In response to a question from Dr. AuBuchon, Dr. Morgan noted that there were
concerns that altered genetic products might be immunogenic, and that this
issue was under study in animal models.
After lunch, Dr. Mark Brantley gave an overview of alpha-I antitrypsin deficiency
and its treatment. Alpha-I antitrypsin is an endogenous anti-inflammatory
molecule which is synthesized in response to infections of the lung and other
organs; it inhibits enzymes such as neutrophil elastase, which degrades lung
tissue. In the absence of alpha-I antitrypsin, the normal degradation of lung
tissue and lung function are accelerated, ultimately to emphysema. Dr. Brantley
pointed out that, at age 63, 85% of the American population is alive, but
only 16% of the alpha-I antitrypsin deficient population is alive. In response
to a question from Dr. Schiff, Dr. Brantley noted that replacement therapy
with alpha-I antitrypsin did not seem to change the course of the liver disease
in alpha-I antitrypsin deficiency.
Ms. Sandra Brandley, the Executive Director of the Alpha-I Antitrypsin National
Foundation, then described the current shortage of alpha-I antitrypsin in
the United States and its effect on patients. Ms. Sarah Everett then described
the shortage from a patients perspective, which was to raise her fear that
suboptimal treatment would increase the chance of recurrent pneumonia and
accelerate the destruction of her lungs. She requested the Committee consider
changing allocation of alpha-I antitrypsin to a patient-based system, that
production be increased to meet demand, that studies be performed to determine
the optimal dose of alpha-I antitrypsin therapy, and that development of new
therapies, such as recombinant alpha-I antitrypsin and inhalation therapy
with alpha-I antitrypsin, be supported. Ms. Julie Swanson, the President of
the National Alpha-l Association, described in more detail the burdens imposed
on patients by the current shortages.
Mr. James Reilly of the American Blood Resources Association then described
the current plasma collection and processing system in the United States for
paid donors. In 1997 there were about 1.5 million donors who gave 13 million
donations which totaled approximately 11 million liters of plasma. Mr. Reilly
noted that the screening process for potential donors decreases the incidence
of I-HIV infection from 320 per 100,000 in the United States population as
a whole to less than 1 per 100,000 selected donors. He described this process
and the additional procedures, such as quarantine of new donors, that contribute
to the safety of plasma derivatives. In response to a question from Dr. Feigal,
Mr. Reilly agreed that the United States market for paid plasma was approximately
6 million liters per year, so more than enough plasma was being collected
to meet this demand.
Ms. Sue Preston of Alpha Therapeutics then spoke on behalf of the International
Plasma Producers Industry Association about fractionation, pooling, and preparation
of final containers. She noted that plasma is 85% water. An initial pool of
4000 liters from about 5000 donors contains 200 to 300 kg of proteins, only
a few of which are used therapeutically. In the 4000 liter pool there would
be about 125 kg albumin, but the fractionation process only yields 70 to 95
kg; for immunoglobulins, while there would be 32 kg, only 10 to 11 kg are
retrieved. There would be about 400 grams of Factor VII, of which 200 to 300
grams would be retrieved. There would be approximately 1 kg of alpha-I antitrypsin,
but since a single therapeutic dose is 4 grams, the 4000 liter pool yields
only about 250 doses. Ms. Preston noted that the relatively low yields of
some plasma derivatives, the need to prepare uniformly therapeutic products,
and the amount of product used to test for efficacy and safety were all reasons
why industry pooled outputs of individual lots.
Dr. Donald Baker then discussed the relation of viral safety and availability
from the manufacturers perspective. He noted that the manufacturers 60-day
quarantine cost $6100 per unit rejected, whereas p24 antigen testing cost
$660,000 per unit rejected. He estimated that Creutzfeldt-Jakob disease recalls
had cost his company approximately $10 million. Dr. Feigal suggested that
an alternative way to express these costs would be in terms of units actually
used rather than units rejected, and estimated that the costs were approximately
$1 per unit of plasma.
Mr. Jan Bult of the International Plasma Products Industry Association then
presented the industry analysis of the causes of the current shortage of plasma
derivatives. These were increased demand, Creutzfeldt-Jakob disease-related
withdrawals, and manufacturing shutdowns. He estimated that demand for intravenous
immunoglobulin was growing at about 9% per year. He stated that the volume
of intravenous immunoglobulin that could not be released because of Creutzfeldt-Jakob
disease-related withdrawals was 186 kg in 1996 and 1066 kg in 1997 (an average
dose is 25 gin). The net available supply of intravenous immunoglobulin, based
on figures compiled by Georgetown Economic Services, was 13,752 kg in 1996,
12,994 kg in 1997, and a projected 13,000 kg in 1998; exports were 2352 kg
in 1996, 2663 kg in 1997, and a projected 2558 in 1998. Mr. Bult emphatically
denied that the industry was stockpiling product. He then presented a table
of the data requested by the Immune Deficiency Foundation, and pledged to
update this data on a quarterly basis. Mr. Bult then described short term
initiatives to minimize the impact of the shortage on patients, and long term
plans to increase production of the product. In response to questions from
Mr. Allen and Dr. Kuhn, Mr. Bult felt that the current shortage had been precipitated
by a number of factors, and that the major factor manufacturing
shutdowns was
something that the industry could not reasonably have anticipated. Dr. Jay
Epstein of FDA asked if industry would be willing to release the approximately
1000 kg of intravenous immunoglobulin withdrawn if it were appropriately labeled,
and Mr. Bult responded that most of this material was still in intermediate
rather than final product form.
The Committee then heard from an industry panel.
The first presenter was Ms. Preston of Alpha Therapeutics, who described Alphas
current capacity, amount of final product exported, improvements in distribution,
plans to increase capacity, and research activities. She described the approximately
130 day production schedule of intravenous immunoglobulin, which includes
the industrys voluntary 60-day hold on plasma products prior to manufacture;
she noted that different fractions completed production at different times.
She then announced that the amount of Alphas intravenous immunoglobulin sold
through wholesalers had decreased from 67% to 16% in the past year, and that
their inventory was minimal. Alpha plans to raise its production of intravenous
immunoglobulin by 40 to 50% by 2003. In response to a question by Mr. Walsh,
Ms. Preston hoped that Alphas alpha-I antitrypsin product could be launched
by 2001, and that Alpha was willing to consider sharing its Fraction IV. 1
paste with other manufacturers who were licensed to produce alpha-I antitrypsin.
In response to a question from Dr. Chamberland, Ms. Preston confirmed that
Alpha did release, at the request of FDA, a lot of intravenous immunoglobulin
labeled to indicate that one donor had been exposed to human growth hormone;
she also noted that there was "quite an internal debate" at Alpha regarding
this action because of its legal risk.
Next, Dr. Larry Guiheen of Baxter discussed that
corporations response to the immunoglobulin shortage. He denied that Baxter
was stockpiling product; he said that ordinarily Baxter would carry a two
month inventory, but that the current inventory was only sufficient for about
14 days. Mr. Guiheen stated that approximately 20% of Baxters intravenous
immunoglobulin was exported, but he noted that Baxter was taking steps to
import some of the product as well; he also noted that Baxters prices for
its intravenous immunoglobulin preparations had not increased since 1994.
Dr. David Spencer then described Bayers response.
He noted the reasons why Bayers production of intravenous immunoglobulin in
1998 would be only about half of the 1997 level. The shortfall is due to a
combination of previous commitments to production enhancements, failure of
the heating system in one plant, and Creutzfeldt-Jakob disease-related product
recalls. He noted that these events would limit Bayers production of prolastin
and clotting factors as well. At the same time, Dr. Spencer cited five projects
that demonstrated Bayers commitment to the field: the development of recombinant
Factor VIII, building new production facilities, investigating new chromatographic
methods to increase yield of immunoglobulins from plasma, purchasing additional
production capacity in Italy, and pursuing research on the transmission of
Creutzfeldt-Jakob disease. In response to a question from Mr. Walsh, Dr. Spencer
indicated that production of alpha-I antitrypsin was running close to capacity,
and he was unsure of the increase in production that an alternative source
of plasma fraction 4.1 would permit.
Dr. William Barnhart of Centeon then discussed
his companys future production plans. Although 1997 production of immunoglobulins
had decreased by 70%, he was hopeful that 1998 production would approach 1996
production levels. Dr. Deborah Dunsire of Novartis then discussed her companys
attempts to optimize distribution of their intravenous inimunoglobulin, which
is manufactured by the Swiss Red Cross. She also noted the impact of Creutzfeldt-Jakob
disease-related withdrawals on the availability of her companys product. The
four withdrawals in 1998 had achieved a return of only 3.6 kg of intravenous
immunoglobulin, but about 15% of the potential supply had to be destroyed
because of these regulatory actions.
After a brief discussion, the meeting was adjourned at 5:45 PM.
The meeting resumed the following morning at 8:00
AM. Dr. Caplan encouraged the Committee to consider monitoring production
numbers, off-label use, exports, use of recombinant analogs of plasma derivatives,
and management of emergency reserves as they formulated their recommendations
during the day.
Mr. James McPherson of Americas Blood Centers then
discussed the complex economics of plasma obtained from voluntary blood donors,
how the threat of Creutzfeldt-Jacob disease-related withdrawals counterbalanced
the attractiveness of an American, albeit older American, voluntary pool of
relatively infrequent donors, and how such an uncertain economic environment
prevented the independent blood centers from investing in the resources necessary
to process their recovered plasma into products such as intravenous immunoglobulin.
Mr. McPherson noted that all American manufacturers of plasma derivatives
preferentially used paid donors because of the risk of Creutzfeldt-Jakob disease-related
withdrawals. Dr. Davey supported Mr. McPhersons assertions by estimating that
80% of the plasma used in the United States was from paid donors, but 80%
of the Creutzfeldt-Jakob disease-related recalls were for volunteer donors.
It was asserted that volunteer donors might be more forthcoming about risks
than paid donors, even if only after the fact, but Dr. McCurdy pointed out
that no data supported that assertion. In subsequent discussion there was
agreement that the current shortages were due to reduced production capacity
rather than lack of raw material, but there was no challenge to Mr. McPhersons
point that the risk of Creutzfeldt-Jacob disease-related recall may have been
a factor limiting investment necessary to create additional production capacity.
Mr. Christopher Lamb then described the American
Red Cross plasma program. The Red Cross contracts processing of its plasma
with Bayer and the Swiss Red Cross. The American Red Cross collects about
6 million donations per year, which translates into 1 million liters of plasma
because the average volunteer donation is
283 ml plasma, whereas the average paid plasmapheresis is around 800 ml. The
smaller volume of plasma per donor has an obvious impact on pool size, because
more volunteer donors are needed to make an equivalent volume of plasma. He
disagreed with assertions by others that a smaller pool size would increase
safety and not decrease availability.
Mr. Lamb estimated growth in the market for intravenous
immunoglobulin at about 10% per year based on historical trends. He reported
that 10% of the Red Cross production of intravenous immunoglobulin was not
released because of Creutzfeldt-Jakob disease-related recall, an additional
6% was recalled, and an additional 6% was not processed beyond the intermediate
level. Mr. Lamb noted that 80% of the American Red Cross recalls were for
reported exposures to dura mater grafts or human growth hormone, and not for
Creutzfeldt-Jakob disease itself. Mr. Lamb noted that the American Red Cross
had two contractual relationships for distributing its intravenous immunoglobulin,
and that they were trying to allocate their remaining supply in the most equitable
manner. Like all previous speakers, Mr. Lamb emphatically denied that his
organization was hoarding product. Mr. Allen asked Mr. Lamb why the American
Red Cross could sell its plasma and Americas Blood Centers could not; in response,
Mr. Lamb pointed out that this was largely because the American Red Cross
contracts for the production capacity and assumes the risk of Creutzfeldt-Jacob
disease-related recalls, which have cost the Red Cross $120 million worth
of product since August 1995.
Dr. Mark Weinstein of FDA then presented that agencys
assessment of the causes of the intravenous immunoglobulin shortage. Dr. Weinstein
estimated the shortfall at about 20% of total demand, and he attributed 60%
of the shortage to plant closings, 20% to Creutzfeldt-Jakob disease-related
recalls, and 20% to increased demand. Dr. Weinstein noted that FDA had been
working with industry in a variety of ways to increase product availability.
In response to a question from Mr. Walsh, Dr. Weinstein agreed that a decrease
in the number of calls to FDA about the shortage should not be taken as evidence
that the shortage was abating. Dr. Davey asked if the FDA would look favorably
on a generic label for all derivative products, saying there is a theoretical
risk of CJD transmission in all derivative products, and if with this label
the FDA would be willing to "really aggressively" relax withdrawal policies;
Dr. Weinstein responded that the subject was under discussion. Public comment
followed a brief recess. Mr. Moran restated the desire of the Immune Deficiency
Foundation to work with manufacturers to insure equitable distribution of
products. Mr. Dubin restated his constituencys concerns about pool size. Ms.
Brandley reiterated her request to FDA to facilitate manufacturing capacity
for alpha-I antitrypsin. Mr. Patrick Robert, of the Marketing Research Bureau,
presented data on the size of the market for intravenous immunoglobulins,
which he estimated at $413 million, and on the market share of the various
corporations. Mr. Robert suggested that one reason why there was more of a
shortage in the United States than elsewhere was that demand was higher in
the United States. Dr. Donald Tankersley then commented on the arguments for
and against reduction of the plasma pool size; his conclusion was that reduction
in pool size would not improve safety of the finished product.
The Committee then began to formulate its recommendations, which were as follows:
I RECOMMENDATIONS FOR THE SHORT TERM
- The Food and Drug Administration, the International
Plasma Producers Industry Association and individual manufacturers and distributers
of plasma derivatives and their recombinant analogs shuld, on a monthly
basis, collect and disseminate standardized information on production, distribution,
and demand for intravenous immunoglobulin, clotting factors (recombinant
and plasma-dervied), and alpha-1 antitrypsin.
2. The Department of Health and Human Services should
explore, in collaboration with industry, health care providers, and appropriate
consumer groups, methods to optimize and standardize allocation of available
products in an equitable manner, including management of emergency supplies
and programs that distribute products directly from manufacturers to registered
consumers.
3. Industry should discuss triage of specific plasma
derivatives to specific patient groups with the Food and Drug Administration,
the Federal Trade Commission, health care providers, and appropriate consumer
groups in order to promote accountability to the public of these practices.
4. Industry should explore with the Food and Drug
Administration the possibility of importing additional supplies of intravenous
and intramuscular immunoglobulin preparations.
5. Industry should explore with the Food and Drug
Administration strategies for reallocating partially processed plasma materials
from one manufacturer to another in order to optimize production of alpha-i
antitrypsin and other plasma derivatives.
6. Industry should explore with the Food and Drug
Administration labeling and disclosure strategies which would increase product
availability without compromising public safety and trust.
7. Industry and government should explore the impact
of a temporary decrease in exportation of plasma derivatives while they are
in short supply in the United States.
II RECOMMENDATIONS FOR THE LONG TERM
Every effort should be made to make recombinant
clotting factors available to all who would benefit from them, and all barriers
to conversion from human to recombinant clotting factors should be removed.
2. The National Institutes of Health should convene
a Consensus Conference on the use of recombinant clotting factors for patients
with bleeding disorders.
3. Industry should explore strategies for the development
of reserve supplies of plasma derivatives and for their allocation during
shortages.
4. The National Institutes of Health and industry
should immediately evaluate alternative dosage schedules and alternative delivery
systems for alpha-I antitrypsin therapy, including prophylaxis strategies
and strategies for treatment during acute exacerbations of disease, and accelerate
the development of gene-based products and gene-directed therapies for alpha-I
antitrypsin deficiency.
5. The National Institutes of Health and industry
should support the continued evaluation of the use and appropriate dose of
intravenous immunoglobulins for indications where its benefit requires further
delineation, and the results of these evaluations should be rapidly disseminated
to the public.
6. Industry should work with the Food and Drug
Administration to expand capacity sufficiently to meet anticipated demand
for plasma derivatives.
7. Industry and government should jointly explore
the antitrust implications of efforts to share data in order to prevent shortages.
The Committee requested an update on the status of all their prior recommendations at the next meeting.
The meeting was adjourned at 3:13 PM.
As required by 4-CFR 101-6.1025(b), these minutes
were reviewed and approved by Dr. Arthur Caplan, Chairman of the Advisory
Committee on Blood Safety and Availability, on July 23, 1998. The transcript
of this meeting can be found at http://www.hhs.gov/partnerfBlood Safety.
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