RNS Number:9666X
Pall Corporation
29 January 2001


           PALL ANNOUNCES ABILITY TO PROVIDE FILTERS TO MEET FDA 
          REQUEST FOR MAKING LEUKOCYTE REDUCED BLOOD MORE WIDELY 
                        AVAILABLE ACROSS THE U.S.


 Joins Medical Experts in Support of FDA Push to Broaden Access to Filtered     
                   Blood To All Americans, Not Just Some


Washington DC (January 26, 2001)--Pall Corporation (NYSE: PLL) announced that
the company has ramped up its manufacturing and is ready and able to supply the
U.S. with filtration technology to meet the nation's needs for pre-storage
leukocyte reduction of all blood components for transfusion. The announcement
was made in a presentation to the Department of Health and Human Services (HHS)
Advisory Committee for Blood Safety and Availability meeting to determine
whether universal leukocyte reduction should be mandated.

"We can confidently state that Pall is ready to meet the needs for universal
leukocyte reduction in the U.S. Our manufacturing capacity is more than enough
to meet the total U.S. requirements with a healthy margin of safety," said Sam
Wortham, President of the Medical Division of Pall Corporation.

Leukocyte reduction is the process where leukocytes (white blood cells) are
filtered from blood to help reduce the incidence of transfusion complications.
Leukocytes are associated with a majority of adverse reactions to a blood
transfusion including fever, alloimmunity, transmission of harmful viruses, and
perhaps postoperative infections. The FDA has repeatedly encouraged the use of
leukocyte reduced blood as safer and purer. The U.S. has moved towards universal
leukocyte reduction, with more than half of the blood supply currently filtered.
But universal leukocyte reduction, where all patients are automatically given
filtered blood, has not been mandated. Consequently, some hospitals and doctors
continue to selectively provide leukocyte reduced blood to only those patients
they believe are at the greatest risk of an adverse reaction to a blood
transfusion.

This has led to an inequity in access to the safest blood possible for all
Americans. Whether a patient receives filtered blood depends upon which hospital
or doctor they see. 
Sam Wortham commented, "Pall is pleased that the FDA has defined its
recommendation for leukoreduction and we are prepared to do our part in ensuring
its timely and efficient implementation. But we remain concerned that with a
continuation of selective use of leukoreduced blood, patients that could benefit
from it will not have access to the safest blood possible." The American Red
Cross, which is committed to 100 percent leukoreduced blood, is urging HHS to
mandate universal leukocyte reduction of America's blood supply.

These sentiments were echoed by several blood experts at the meeting and also in
a poll of the American public conducted by Roper Starch Worldwide. The survey
found that an overwhelming majority of Americans want the choice of receiving
leukocyte reduced blood in the event they or a family member needs a blood
transfusion. And they are distressed that doctors or hospitals decide which
patients receive filtered blood without informing their patients, thus negating
their right to make an informed decision. 


Higher Level of Filtration Standards Required
Pall Corporation has led the filtration industry in the development of
technology that attains the lowest level of residual leukocytes. Its filtration
systems produce blood products with leukocyte levels that exceed both the
current U.S. standard (less than 5 million residual cells) and the new standard
proposed by the FDA in its most recent draft Guidance Document to the Industry
of less than one million residual cells per unit. 

Since the FDA and blood processors originally posed the question about
manufacturing capacity, Pall acted on the charge and ramped up its manufacturing
capabilities. As early as April 2000, Pall reported the addition of a
manufacturing facility in Italy so that Europe could be served locally, which
allowed for rapid expansion for routine high volume filtration in the U.S.

Pall has worked with the ten nations, including the United Kingdom, France,
Austria and Canada, that have already implemented universal leukocyte reduction
as well as with the 14 countries (including the U.S.) that are moving toward 100
percent filtered blood.

Mr. Wortham explained, "Based on our experience with these countries, it has
taken 6 to 18 months for implementation of universal leukocyte reduction. The
status of the implementation plans of the U.S. blood centers will be a key
factor in how quickly universal leukocyte reduction can be achieved. For those
centers that have already made the commitment and plans for 100 percent
leukoreduction, it is quite possible that with our experience and technology,
implementation time can be abbreviated."

Mr. Wortham concluded his presentation by pledging that Pall will continue to
work hand in hand with the U.S. blood community to ensure consistently reliable
filtration products that meet the highest standards of quality. In addition,
Pall is prepared to work with the health care community to help bring about
positive change in reimbursement to improve the safety of the blood supply so
that leukocyte reduced blood can be available to all, not just some, Americans
that need a blood transfusion. 

Highlights of HHS Meeting
The opening of the meeting included a debate about universal leukocyte reduction
with a review of its clinical benefits and the arguments about selective versus
universal use. This discussion basically reviewed points made at earlier HHS and
FDA meetings.

The afternoon session contained testimony from the American Hospital Association
and University HealthSystem Consortium. Their arguments focused on the cost of
universal leukocyte reduction and the financial burden hospitals might face if
it were mandated. 

These arguments were rebutted by testimony from representatives from hospitals
that are already practicing universal leukocyte reduction. Some have found it
has been cost neutral and others that it has actually decreased hospital costs,
especially due to improvement in patient outcomes. For example, Nancy Chance,
Blood Bank Coordinator explained that Riverview Hospital, in Noblesville,
Indiana has saved about $3.25 million, with a majority of the savings from a
reduction in post-operative infection. Neil Blumberg, MD, presented findings
from the latest study conducted at the University of Rochester Medical Center,
of cardiac surgery patients. The study found a two percent reduction in patient
mortality and a cost savings of $1,700 per patient that received leukoreduced
blood transfusion compared to patients that received a standard transfusion. Dr.
Blumberg extrapolated that if leukocyte reduced blood were used for cardiac
surgery patients, anywhere from 10,000 to 30,000 lives would be saved each year
and there would be a cost savings of approximately $6 to $12 billion annually.
He said, "Leukoreduction for cardiac surgery has the potential to prevent a
greater number of deaths annually in the U.S. than have occurred in the last two
decades from the entire AIDS epidemic due to transfusion. We urge the Committee
to consider recommending a policy of leukoreduction of all transfusions to
surgical patients." 

In addition, several physicians stated that the cost of selective use of
leukocyte reduced blood could be greater than providing it to all patients who
need a transfusion.

Several patient advocacy groups spoke throughout the afternoon. The Hemophilia
Federation of America (HFA) noted that the benefits of leukocyte reduction
outweigh the cost and that pre-storage leukoreduction of all blood is the most
cost effective way to provide safer blood to all Americans. HFA reiterated its
plea that the U.S. err on the side of safety and not revisit the early 80s with
the HIV holocaust or the more recent Hepatitis C onslaught and continue to
educate both patients and physicians on the importance of leukoreduced blood. 

About Pall
Pall Corporation is the acknowledged technology leader in the increasingly
complex and demanding filtration industry and has been, for more than 50 years.
Pall serves customers throughout the health care and industrial marketplace. In
addition to providing leading-edge products for transfusion medicine, Pall is a
primary supplier to the biopharmaceuticals, semiconductor, and municipal
drinking water industries, to name a few. Pall blood filters are used in all ten
countries that have mandated universal leukocyte reduction and in the 14
countries, including the US, that are moving toward routine blood filtration. In
addition, Pall is the co-developer and will be the exclusive marketer of
INACTINE(TM) Pathogen Inactivation technology, under clinical investigation, to
inactivate viruses, bacteria and protozoa by disrupting pathogen nucleic acid
replication in red blood cells and platelets. Pall is also involved in extensive
research and development in many other areas of blood safety, including devices
designed for sensitive and early detection of bacterial contamination of
platelets, considered to be one of the greatest transfusion risks today.

Pall (NYSE: PLL) has annual sales of over $1.2 billion. The Company is
headquartered in East Hills, New York and has operations in over 30 countries.
For more information contact Patrice Radowitz, media, 516.484.3600 ext. 6111 or
e-mail pat_radowitz@pall.com and Diane Foster, investors, 516.484.3600 ext 6109
or e-mail diane_foster@pall.com.

Editor's note: Testimony of Pall Corporation attached. Testimony from other
presenters at the HHS meeting, results of the Roper Starch Survey, plus B-roll
footage featuring soundbites from physicians, a patient getting a blood
transfusion and blood bank footage is also available. B-roll satellite feed:
Friday, January 26, 2001, 2:30-2:45 PM EST, Galaxy 3-R C-Band, Transponder 2
Downlink 3740 V, Audio 6.2 & 6.8.



             REMARKS of SAM WORTHAM, PRESIDENT OF PALL MEDICAL 
                             PALL CORPORATION
                             at Meeting of the 
               COMMITTEE FOR BLOOD SAFETY AND AVAILABILITY 
                 DEPARTMENT OF HEALTH AND HUMAN SERVICES
                              January 25, 2001


Good afternoon. I am Sam Wortham, President of the Medical Group of companies
within Pall Corporation. We are the dominant developer and supplier of
filtration technology to hospitals and blood centers. Pall is a fifty-four year
old company with 32 years in the medical filtration field. We sell directly and
to other suppliers that support U.S. blood processing needs. We are global and
provide products and systems in all countries that leukoreduce their blood. With
all due respect to the other filter manufacturers here today, Pall is the
leader. We have more experience, more products and more services to offer our
customers than anyone in the world.

We are not here today to speak on the merits and clinical benefits of leukocyte
reduction. Many of these benefits have been established and documented in the
Circular of Information for the Use of Human Blood and Blood Components. The
Food and Drug Administration has stated at several forums and in its Draft
Guidance this week, its support for universal leukocyte reduction as an
improvement in both blood safety and purity.

As we have already heard this morning, additional data about leukocyte reduction
can still be sought, and could prove to be useful in furthering our knowledge.
It will not remove or reverse what we already know. Therefore we cannot justify
postponing action that could benefit the public health without incurring any
appreciable risk. 

We at Pall are pleased that the question posed to this committee is whether or
not there is a need for a mandate for the implementation of universal leukocyte
reduction. We are pleased because of several concerns about the practice of
selective leukocyte reduction. As Dr. Ness so eloquently said this morning,
there are significant problems with selective transfusion protocols. Many
patients who meet criteria for the protocol, and should have leukocyte reduced
blood are not recognized by the physician. And that it would be very difficult
and perhaps indefensible to put at risk a subgroup of patients on the merit of
doubt regarding its cost savings. If even 20% of patients are excluded from ULR,
the cost of special conditions and handling of non-filtered blood is more
expensive than filtering one hundred percent. And there are many blood
processing experts here today to attest to that. 

How can we justify subjecting any patient to a potential transfusion adversity
when there is technology available to reduce the frequency of such a risk? How
can we consider mortgaging someone's future health since we cannot reliably
predict what a patient's future blood transfusion needs will be and thereby
compromise their health and the cost of their health care tomorrow by our
actions today?

I can't imagine that the American public would believe it is either just or
equitable that what the FDA characterizes as a safer and purer blood product
would not be made available to all people who need a blood transfusion. I
understand they are distressed that doctors and hospitals make the choice of who
receives filtered blood without informed consent on the part of the patient. I
know you will be hearing more about how the public feels from patient
organizations and also from a poll of the general public that will be presented
later today.

If universal leukocyte reduction is not mandated, we fear that our country may
move forward with a two-tier blood system based on cost. And as a nation we
should not view blood as a commodity where the economics of supply and demand
are applied. This should not be the driver in deciding on the routine use of new
and better technologies at the expense of patient safety, especially in an
environment where there is so little direct patient advocacy for blood safety.

I would like to use the remainder of my time today to review how Pall
Corporation can help make universal leukocyte reduction a reality in the U.S.
The three areas that I will focus on are:

1. The quality and standards Pall can bring to the implementation of universal  
   leukocyte reduction in the U.S.,
2. Our manufacturing capacity to meet the needs of ULR here, and
3. Our experience in the planning and implementation of ULR around the world and
   how we can apply that to the U.S.

Pall has been in the forefront working with the scientific community to
establish quality standards for counting residual leukocytes. We published the
reference guide for the U.S. blood banking community and provided training to
both hospitals and blood centers around the country. Pall has led the filtration
industry in the development of products and technology that consistently attain
the lowest level of residual leukocytes to assure a consistent and reliable
leukocyte reduction process. Our products exceed the current U.S. standard of
less than 5 million residual cells and also exceed the standard set by the
Council of European Standards of 1 million residual cells and the new FDA
proposal of less than 1 million residual cells. Our products consistently
average 200,000 residual cells, providing a greater margin of safety than any
other filtration device. This is the technology that Pall currently provides
around the world and across the U.S. And we will continue to provide the U.S.
with the highest quality technology in the ongoing move toward universal
leukocyte reduction.

In anticipation of universal leukocyte reduction in the U.S., both blood
processors and the FDA had previously raised the question of product
availability. At the April 2000 meeting of this committee, we were able to
report that Pall ramped up its filter production and added an additional
state-of-the-art manufacturing facility in Italy so that Europe can be served
locally. As a result, we accomplished our goal for increased manufacturing
capacity to support a rapid expansion for routine high volume blood filtration
in the U.S. This was based on the expectation of virtual ULR in the U.S. by the
end of the year 2000, as expressed by the FDA at the Dec. 10th 1999
Implementation Review Meeting.

Although we do not know for certain how much of the U.S. blood is currently
being leukocyte reduced since we have heard different numbers from various
sources, we arguably estimate it to be approaching about 60 percent today. We do
know that we can state here today that Pall is ready and able to meet the need
for filtration technology for Universal Leukocyte Reduction in the U.S. Our
capacity is more than enough to meet the total U.S. requirements with a healthy
margin of safety.

I'd like to take a few minutes to tell you about some of our experiences around
the world in the planning and implementation of ULR and its applicability to the
U.S.

Pall has worked with the ten nations that have implemented universal leukocyte
reduction and also with the 14 countries that are moving toward routine
filtration. We have worked closely with many of these nations including the
United Kingdom, France, Austria and Canada, to help ensure efficient and timely
implementation. 

For example, in Canada, Pall has been an integral part of the implementation
team in planning and serving as a quality control testing base starting with the
training period through implementation and operation. In addition to providing
our technology and filter systems, we provide statistical process mapping for
the 14 blood centers of the Canadian Blood Services and the blood centers of
HemaQuebec. We continue in that role today.

Based on our efforts around the world, albeit on a smaller scale than the U.S.
and in some cases, where there's a more united blood practice, we know that the
implementation of ULR will not be achieved overnight. It has averaged anywhere
from 6 to 18 months in the countries we have worked with. Based on our
experience, we can work together with the blood community to ensure that ULR is
achieved with the highest quality standards and in the shortest time frame
possible. However, this cannot be done in a reasonable time frame if the blood
banking community has not yet developed its implementation plans. We know that
the American Red Cross, as you have already heard, has made a commitment to ULR
and has made significant strides in implementation. We are pleased to be working
with them. We request that this committee ask the blood banking community here
today what plans and processes they have already put into place to follow the
recommendation that the FDA's BPAC committee made over one and one-half years
ago. Pall, as a manufacturer is doing its part but we can only continue to be
effective in meeting the goal if all sides of the equation have also done their
part. 

I want to conclude my testimony here today by reiterating a point made by Dr.
Lee of the FDA at a BPAC meeting. He said, Insufficient reimbursement, not cost,
is the primary obstacle to ULR. Pall also believes this is the case. We do
appreciate that cost is an issue and, at this juncture, hospitals bear the bulk
of the burden. 

We at Pall want to work together with the community not only to ensure
consistently reliable products that meet the highest standard of quality for URL
-- timely, efficiently and cost- efficiently. We also want to work together to
help bring about positive change and direction for reimbursement to help improve
the safety of the blood supply for all Americans. We are for mandated ULR.

Thank your for your time and the opportunity to speak at this meeting. I'd be
happy to answer any questions the Committee may have.


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