Blood Safety: Recalls and Withdrawals of Plasma Products (Testimony,
05/07/98, GAO/T-HEHS-98-166).

GAO discussed the amount of plasma products, and in particular, the
amount of intravenous immune globulin (IVIG), that was being lost due to
removal of products from the market, focusing on the: (1) number of
recent product recalls and withdrawals; (2) reasons for these actions;
(3) different types of plasma products affected; (4) amount of product
that has been returned as a result of these actions; and (5) current
shortage of IVIG of reducing the number of donors for each plasma
product.

GAO noted that: (1) the data showed that only a small proportion of
distributed IVIG--about 1.1 percent--has been removed from the market as
a result of recalls or withdrawals; (2) however, only 5 percent of the
vials of plasma products that were recalled or withdrawn has been
retrieved to date; (3) while additional quantities might still be
retrieved, some portion of these products has already been transfused or
is otherwise unretrievable; (4) further, changes to reduce the number of
donors in each product appear unrelated to the current shortages; (5)
during the period GAO reviewed, 11 manufacturers reported to the Food
and Drug Administration (FDA) that they undertook a total of 12 recalls
(affecting 33 lots of 7 types of plasma products) and 38 withdrawals
(affecting 1,001 lots of 10 types of products); (6) the reasons for the
product recalls varied, but generally they related to specific
manufacturing errors resulting in problems in product potency, sterility
assurance, or incorrect labeling; (7) the product withdrawals were all
related to donors who were diagnosed with Creutzfeldt-Jakob disease
(CJD) or were considered to be at increased risk for CJD; (8) as
reported to FDA, the proportion of IVIG vials retrieved following a
recall was 15 percent, which amounted to less than 1 percent of total
IVIG distributed in 1997; (9) in total, about one-third, or 38 percent,
of the number of vials of all plasma products recalled has actually been
retrieved from distribution or known to be destroyed; (10) the
proportion of distributed products retrieved following a withdrawal has
been much lower; (11) data from the plasma product manufacturers showed
6 percent of the vials of IVIG that were withdrawn to actually have been
recovered, representing 1 percent of the total product distributed in
1997; (12) for other plasma products, the proportion of distributed
vials retrieved following a withdrawal was 2 percent; and (13)
manufacturers also claim that their production of IVIG was reduced by 5
to 10 percent in 1997 because they had to quarantine or destroy plasma
because of CJD risk, but these amounts cannot be verified.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-HEHS-98-166
     TITLE:  Blood Safety: Recalls and Withdrawals of Plasma Products
      DATE:  05/07/98
   SUBJECT:  Product recalls
             Health hazards
             Neurological diseases
             Product safety
             Health care services
             Medical supplies

             
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Cover
================================================================ COVER


Before the Subcommittee on Human Resources, Committee on Government
Reform and Oversight, House of Representatives

For Release on Delivery
Expected at 10:00 a.m.
Thursday, May 7, 1998

BLOOD SAFETY - RECALLS AND
WITHDRAWALS OF PLASMA PRODUCTS

Statement of Bernice Steinhardt, Director
Health Services Quality and Public Health Issues
Health, Education, and Human Services Division

GAO/T-HEHS-98-166

GAO/HEHS-98-166T


(108371)


Abbreviations
=============================================================== ABBREV

  CJD - Creutafeldt-Jakob disease
  FDA - Food and Drug Administration
  IVIG - intravenous immune globulin

BLOOD SAFETY:  RECALLS AND
WITHDRAWALS OF PLASMA PRODUCTS
============================================================ Chapter 0

Mr.  Chairman and Members of the Subcommittee: 

We appreciate the opportunity to be here this morning to discuss our
examination of plasma product recalls and withdrawals.  Plasma is the
liquid portion of blood, containing nutrients, electrolytes
(dissolved salts), gases, albumin, clotting factors, hormones, and
wastes.  Many different components of plasma are used for medical
treatment, from treating the trauma of burns and surgery to replacing
blood elements that are lacking as a result of disease, such as
hemophilia.  It is estimated that each year some half million people
receive products manufactured from human plasma, including over
20,000 who receive intravenous immune globulin (IVIG). 

In the past 6 months, there have been reported shortages in certain
plasma products, particularly the immune globulins.  Many different
factors have been cited as possible causes of the current shortage,
including recalls and withdrawals of plasma products, delays in
production due to problems in compliance with the Food and Drug
Administration's (FDA) current good manufacturing practices, and
increased demand due partly to new uses of the products. 

You asked that we review the first of these possible causes--recalls
and withdrawals--to determine the amount of plasma products, and in
particular, the amount of IVIG, that was being lost due to removal of
products from the market.  Recalls are used to remove products from
the market that violate the laws or are defective, while withdrawals
are used to remove products that present only minor or unknown risks
or are removed completely at the manufacturer's discretion. 
Specifically, you asked us to report on the number of recent product
recalls and withdrawals, the reasons for these actions, the different
types of plasma products affected, and the amount of product that has
been returned as a result of these actions.  You also asked that we
examine the impact on the current shortage of IVIG of reducing the
number of donors for each plasma product. 

To answer these questions, we obtained information from FDA and the
major plasma product manufacturers.\1 Specifically, we obtained data
on recalls from FDA, and because companies are not requested to
provide FDA with data on market withdrawals, we obtained these data
from the manufacturers.\2 We sought information on all plasma product
recalls and withdrawals from December 1996 through mid-April 1998. 

In summary, the data showed that only a small proportion of
distributed IVIG--about 1.1 percent--has been removed from the market
as a result of recalls or withdrawals.  However, only 5 percent of
the vials of plasma products that were recalled or withdrawn has been
retrieved to date.  While additional quantities might still be
retrieved, some portion of these products has already been transfused
or is otherwise unretrievable.  Further, changes to reduce the number
of donors in each product appear unrelated to the current shortages. 

During the period we reviewed, 11 manufacturers reported to FDA that
they undertook a total of 12 recalls (affecting 33 lots of 7 types of
plasma products) and 38 withdrawals (affecting 1,001 lots of 10 types
of products).  The reasons for the product recalls varied, but
generally they related to specific manufacturing errors resulting in
problems in product potency, sterility assurance, or incorrect
labeling.  The product withdrawals were all related to donors who
were diagnosed with Creutzfeldt-Jakob disease (CJD) or were
considered to be at increased risk for CJD.\3

As reported to FDA, the proportion of IVIG vials retrieved following
a recall was 15 percent, which amounted to less than 1 percent of the
total IVIG distributed in 1997.  In total, about one-third, or 38
percent, of the number of vials of all plasma products recalled has
actually been retrieved from distribution or known to be destroyed. 
The proportion of distributed products retrieved following a
withdrawal has been much lower.  Data from the plasma product
manufacturers showed 6 percent of the vials of IVIG that were
withdrawn to actually have been recovered, representing 1 percent of
the total product distributed in 1997.  For other plasma products,
the proportion of distributed vials retrieved following a withdrawal
was 2 percent.  Manufacturers also claim that their production of
IVIG was reduced by 5 to 10 percent in 1997 because they had to
quarantine or destroy plasma because of CJD risk, but these amounts
cannot be verified. 


--------------------
\1 The major manufacturers of plasma products distributed in the
United States include Alpha Therapeutic, Baxter Healthcare, Bayer
Corporation, Centeon, and the Swiss Red Cross.  The American Red
Cross collects and distributes plasma products, but its products are
manufactured under contract by Baxter Healthcare and the Swiss Red
Cross.  For convenience, we discuss all of these entities as
manufacturers.  Together, these manufacturers account for over 95
percent of the production of plasma products. 

\2 Manufacturers are requested to notify FDA when they are recalling
or withdrawing products from the market; they are requested to report
to the agency on the amount of product returned under a recall, but
not under a withdrawal. 

\3 Creutzfeldt-Jakob disease is a degenerative neurologic disease
that leads to progressive dementia and death. 


   BACKGROUND
---------------------------------------------------------- Chapter 0:1

Plasma products are manufactured through a process known as
fractionation.  This process separates the various active components
of plasma, which are further manufactured into clotting factor
products for hemophiliacs, albumin for burn and shock victims, and
immunoglobulin preparations for immune-deficient persons and to treat
and prevent a variety of diseases.  (See appendix.)

Most manufacturing facilities use large plasma pools to manufacture
sufficient quantities of products.  These plasma pools are derived by
combining units from individual donations.  The number of units
combined into a common mixture for processing is known as "pool
size." In the past, these plasma pools included as many as 400,000
donors, but recent steps to reduce the number of donors to which a
patient may be exposed have led to reductions in the size of the
plasma pools to the general range of 60,000 donors.  Plasma used for
plasma-derived products manufactured and distributed in the United
States is donated only by U.S.  donors in collection facilities
licensed and registered with the FDA.\4

Manufacturers must be licensed and registered with the FDA and must
comply with regulations governing current good manufacturing
practices.  Each product must be separately licensed, and the
manufacturing facilities are subject to FDA inspection.  FDA
regulations govern the recall or withdrawal of marketed plasma
products. 

Recalls are a manufacturer's removal or correction of a marketed
product that the FDA considers to be in violation of the laws it
administers and against which the agency would initiate legal
action--for example, seizures--if the product was not recalled.  A
recall is generally a voluntary action on the part of the
manufacturer to protect the public from products that present a risk
of injury or are otherwise defective, although FDA can order a recall
if the manufacturer does not act.  In any case, FDA monitors recalls
and assesses the adequacy of a manufacturer's efforts in a recall. 
Among other checks, the recalling manufacturer is requested to submit
periodic recall status reports to the appropriate FDA district office
so that the agency can assess the progress of the recall. 

Withdrawals are defined as a manufacturer's removal or correction of
a distributed product that involves a violation not subject to legal
action by the FDA or that involves no violation, such as normal stock
rotation practices, routine equipment adjustments, and repairs. 
Companies are not requested to submit information on products
retrieved under voluntary market withdrawals.  FDA has stated that it
does not routinely request such information because it focuses its
limited resources in areas in which the risk to the public health is
viewed to be the most significant. 

FDA classifies actions to remove products from the market due to CJD
risks as voluntary market withdrawals because the products are not
considered to be in violation of the regulations and laws
administered by FDA.  Because there are no known cases of CJD
transmission resulting from blood transfusion, FDA concluded that the
risk of transmission of CJD by blood components and plasma
derivatives is theoretical.  The agency has nevertheless been
developing a policy that recommends the exclusion of donors at risk
for CJD and the withdrawal of blood components and plasma products
prepared from such donors. 

Since FDA issued a memorandum to blood establishments in December
1996 stating this policy, many withdrawals of plasma products related
to CJD risks have occurred.  This memorandum noted that CJD may be
acquired by exposure to infectious material\5 or may arise
spontaneously at high frequency in persons with certain genetic
mutations or at low frequency on an unknown basis.  Those considered
to be at increased risk include donors who have had blood relatives
with CJD or have been told that their family is at an increased risk
for CJD, those who have received pituitary-derived human growth
hormone, and those who have received a dura mater graft. 

The memorandum recommended that when blood establishments identify
donors who were either subsequently diagnosed with CJD or at risk for
CJD, plasma manufacturers should (1) immediately retrieve and
quarantine products under the control of the blood establishment that
were previously collected from the donor, (2) direct their consignees
to immediately retrieve and quarantine any implicated products, and
(3) quarantine and destroy any plasma derivatives. 


--------------------
\4 Plasma products manufactured by the Swiss Red Cross for
distribution in the United States use plasma obtained from the
American Red Cross, the New York Blood Center, and other blood
establishments in the United States. 

\5 Transmission of CJD has been documented to have occurred in
transplants of infected dura mater or from treatments with
pituitary-derived human growth hormone from an infected source.  Dura
mater is the fibrous membrane forming the outer sheathing of the
brain. 


   RECALLS AND WITHDRAWALS HAVE
   NOT REMOVED SIGNIFICANT
   PORTIONS OF MARKETED PRODUCTS
---------------------------------------------------------- Chapter 0:2

The removal of marketed products through voluntary recalls and
withdrawals has been widely cited as a major contributor to the
current shortage.  Our review determined that only a small portion of
product has thus far been returned or destroyed in response to either
of these types of actions. 


      RECALLS HAVE NOT RESULTED IN
      SIGNIFICANT LOSSES OF IVIG
-------------------------------------------------------- Chapter 0:2.1

Manufacturers reported to FDA that they voluntarily initiated a total
of 12 recalls of plasma products within the United States during the
16-month period we reviewed.  Recalls were related to such issues as
breaches in sterility, lots tested at less than full potency, and
patients reporting hives after injection of a product.  We obtained
data for each of the recalls from FDA, including the number of vials
distributed and the number of vials returned or destroyed.  Details
for each recall are provided in table 1. 



                                         Table 1
                         
                           Plasma Product Recalls, December 23,
                                  1996, to April 9, 1998

                                                                   Vials returned or
                                                                       destroyed
                                                               --------------------------
                                                    Number of
                                   Date of              vials
Product              Manufacturer  recall            recalled      Number\a       Percent
-------------------  ------------  ------------  ------------  ------------  ------------
Rho (D) immune       Ortho         Mar. 9, 1998       Unknown       Unknown       Unknown
globulin             Diagnostic

Albumin              Bayer         Jan. 9, 1998        15,777            19          0.1%
                     Corporation

Rho (D) immune       Ortho         Oct. 16,          60,975\b        47,982            79
globulin             Diagnostic    1997

Antihemophilic       Baxter        July 12,             5,324         4,820            91
factor               Healthcare    1997

Rho (D) immune       Bayer         June 26,            41,190           284           0.7
globulin             Corporation   1997

Antihemophilic       Baxter        May 24, 1997        18,116          7079            39
factor               Healthcare

Cytomegalovirus      Massachusett  May 6, 1997          3,677            28           0.8
immune globulin      s Public
                     Health
                     Biologic
                     Labs

Immune globulin      Baxter        Apr. 23,            10,173           480             5
(IV)                 Healthcare    1997

Immune globulin      Alpha         Mar. 7, 1997         2,189         1,363            62
(IV)                 Therapeutic

Coagulation factor   Centeon       Feb. 28,               883           546            62
IX                                 1997

Thrombin             Parke-Davis   Feb. 27,             5,915         1,062            18
                                   1997

Antihemophilic       Centeon       Feb. 21,             1,908            28             1
factor                             1997

=========================================================================================
Total\c                                               166,127        63,691           38%
-----------------------------------------------------------------------------------------
\a As of April 1998. 

\b Recall of this Rho (D) immune globulin is based on number of
syringes (not vials). 

\c Totals do not include the most recent recall, for which the amount
of product returned or destroyed is not yet available. 

The proportion of product recovered or destroyed as of April 1998
varied widely across the separate recalls, ranging from a high of 91
percent to a low of 0.1 percent, with an average recovery rate per
recall of 33 percent.  However, the recovery rate was high enough on
one large recall so that, of the total 166,127 vials recalled, some
38 percent had been returned or destroyed. 

Two of the recalls involved IVIG:  one because of a labeling problem,
and the other because of a higher than expected rate of hives in the
recipients.  As a result of the two recalls, 15 percent of the vials
have been returned or destroyed.  This represented 0.07 percent of
the total volume of 15.7 million grams of IVIG the manufacturers told
us they distributed in the United States in 1997.  Both IVIG recalls
occurred in the spring of 1997, prior to reports of severe shortages
in these products. 


      ONLY A SMALL PROPORTION OF
      PRODUCT LISTED FOR
      WITHDRAWAL HAS BEEN
      RECOVERED
-------------------------------------------------------- Chapter 0:2.2

From December 23, 1996, to April 9, 1998, manufacturers initiated 38
withdrawals of plasma products in the United States.\6 Among the
major plasma manufacturers, the Swiss Red Cross had the most
withdrawals announced during this period (16), while Alpha
Therapeutic had only 1, and Centeon had none.  Each withdrawal was
related to donors who were at increased risk of CJD.  Overall, only 3
percent of the vials withdrawn has been returned to manufacturers. 

Twenty-six of the 38 withdrawals by four manufacturers involved at
least some lots of IVIG.  Of the 381,442 total vials withdrawn, only
23,404, or 6 percent, were recovered as of April 1998.  The
proportion withdrawn that was actually recovered varied from a low of
0.3 percent to a high of 18 percent across the different
manufacturers.  The portion retrieved amounts to 161,212 grams, which
represented 1 percent of the 15.7 million grams of IVIG distributed
in the United States in 1997.  Information for each of the involved
manufacturers is provided in table 2. 



                          Table 2
          
          Withdrawals of IVIG, December 23, 1996,
                      to April 9, 1998

                      Number    Number    Number
                          of  of vials  of vials   Percent
                    withdraw  withdraw  returned  of vials
Manufacturer             als         n        \a  returned
------------------  --------  --------  --------  --------
American Red               6   110,702     2,703        2%
 Cross\b,c
Alpha Therapeutic          1     8,048     1,472        18
Baxter                     5   109,942       312       0.3
 Healthcare\c
Swiss Red Cross\d         14   152,750    18,917        12
==========================================================
Total                     26   381,442    23,404        6%
----------------------------------------------------------
\a As of April 1998. 

\b Data received from the American Red Cross represent 80 percent of
the product they supplied (the other 20 percent is captured in the
Swiss Red Cross data). 

\c In addition, the American Red Cross and Baxter Healthcare had
withdrawals of fraction IV-1 paste and fraction IV-4 paste, which can
be further processed into IVIG.  It is unknown how much this would
represent in terms of number of vials. 

\d These data include plasma obtained from and processed under
contract for distribution by the American Red Cross. 

Of the 38 withdrawals, 30 included plasma products other than IVIG. 
Some withdrawals were of a single product, while others involved
multiple products.  The withdrawn products included albumin, alpha-1
proteinase inhibitor, antihemophilic factor, coagulation factor IX,
and plasma protein fraction.  In addition, pastes that are
distributed for further manufacture into plasma derivatives were also
involved in some of the withdrawals.\7 Data related to the recovery
of these other withdrawn plasma products are provided in table 3. 



                          Table 3
          
           Withdrawals of Other Plasma Products,
            December 23, 1996, to April 9, 1998

                      Number    Number    Number
                          of  of vials  of vials   Percent
                    withdraw  withdraw  returned  of vials
Manufacturer             als         n        \a  returned
------------------  --------  --------  --------  --------
American Red Cross         9   742,377    17,523        2%
Alpha Therapeutic          1    57,032    14,951        26
Baxter Healthcare          7   623,988     1,486       0.2
Bayer Corporation          7   131,011     3,800         3
Swiss Red Cross\b          9   193,411     222\c       0.1
==========================================================
Total                   30\d  1,747,81    37,982        2%
                                     9
----------------------------------------------------------
Note:  Products include albumin, alpha-1 proteinase inhibitor,
antihemophilic factor, coagulation factor IX, and plasma protein
fraction. 

\a As of April 1998. 

\b These data include plasma obtained from and processed under
contract for distribution by the American Red Cross. 

\c Information provided to us by the Swiss Red Cross noted that they
did not know how many vials were returned for the vast majority of
withdrawals of albumin. 

\d Some withdrawals involved multiple manufacturers. 

Of the 1,747,819 vials of other plasma products that were listed for
withdrawal, only 37,982 have been returned to the manufacturer.  This
represents a rate of 2 percent.  When all the withdrawals are
combined across the full set of products, including IVIG, only 3
percent of the total number of vials of distributed products that
were sought have been returned. 

Overall, of the 393,804 vials of IVIG the manufacturers attempted to
remove from the market through either recalls or withdrawals, only
25,247 vials, or 6 percent of this amount, has been recovered,
representing 1.1 percent of the total volume of IVIG distributed in
1997.  Across all the plasma products that the manufacturers
attempted to remove from the market through either recalls or
withdrawals, of the 2,295,388 total vials sought, only 125,077 vials,
or 5 percent of this amount, has been recovered. 

The recalls and withdrawals represented attempts to recover products
that had already been distributed.  In addition to these distributed
products, the FDA memorandum on CJD also calls for quarantine and
destruction of plasma derivatives that are in production.  The
manufacturers have stated that their in-process losses due to CJD
notifications have been significant.  Three manufacturers provided
data to us showing that they lost approximately 5 to 10 percent of
their 1997 production of IVIG due to CJD risks.  However, we did not
verify these data. 


--------------------
\6 Because companies are not required to provide FDA data on market
withdrawals, we obtained data on the proportion of product withdrawn
and, of that, the proportion recovered as of April 1998 from the
manufacturers involved in these actions.  We did not verify these
figures. 

\7 Specific lots of fraction I+II+II paste, fraction IV-1 paste, and
fraction IV-4 were variously involved in 12 of the withdrawals. 


   CHANGES TO REDUCE THE NUMBER OF
   DONORS IN EACH PLASMA PRODUCT
   APPEAR UNRELATED TO CURRENT
   SHORTAGES
---------------------------------------------------------- Chapter 0:3

We also examined the impact of reducing the number of donors in each
plasma product, which some plasma product suppliers have cited as
contributing to the current shortage of IVIG.  In testimony before
this Subcommittee last July, the major plasma product manufacturers
pledged to reduce the risk of transmission from infected donors by
adopting voluntary restrictions on pool size and limiting to 60,000
the number of different donors whose plasma could be used in a single
production run.\8 However, the manufacturers stated that it would
take some time to implement the changes necessary to achieve such a
reduction, and implementation of the policy was set for January 1998. 
Because the manufacture of plasma products takes approximately 6
months, products manufactured under the reduced plasma pool size
restrictions are still in production and have not reached the market. 
In fact, the manufacturers told us that they expect it will be
January 1999 before they finish distributing all plasma products
manufactured prior to the pool size reductions.  At the time that the
severe shortage of IVIG was first noted in November 1997, plasma
products being released for distribution were those that had begun
production approximately 6 months earlier, around April to May 1997. 
Thus, the current shortages predate changes to reduce the number of
donor exposures. 

This concludes my prepared statement, Mr.  Chairman.  I will be happy
to respond to any questions that you or Members of the Subcommittee
may have. 


--------------------
\8 "Food and Drug Administration Oversight:  Blood Safety and the
Implications of Pool Sizes in the Manufacture of Plasma Derivatives,"
hearing before the Subcommittee on Human Resources of the Committee
on Government Reform and Oversight, House of Representatives, 105th
Congress, First Session, July 31, 1997. 


PLASMA PRODUCTS MANUFACTURED AND
DISTRIBUTED IN THE UNITED STATES
==================================================== Appendix Appendix

Table I.1 lists the plasma products manufactured and distributed in
the United States and the primary uses of each. 



                         Table I.1
          
          Plasma Components and Their Primary Uses

Component               Primary uses
----------------------  ----------------------------------
Albumin                 To restore plasma volume in
                        treatment of shock, trauma,
                        surgery, and burns

Alpha-1 proteinase      To treat emphysema caused by
inhibitor               genetic deficiency

Antihemophilic factor   For prophylaxis and treatment of
concentrate (factor     hemophilia A bleeding episodes
VIII)

Anti-inhibitor          To treat bleeding episodes in the
coagulant complex       presence of factor VIII inhibitor

Antithrombin III        To prevent clotting and
                        thromboembolism associated with
                        liver disease, antithrombin III
                        deficiency, and thromboembolism

Coagulation factor IX   For prophylaxis and treatment of
(human)                 hemophilia B bleeding episodes and
                        other bleeding disorders

Cytomegalovirus immune  For passive immunization
globulin                subsequent to exposure to
                        cytomegalovirus

Factor IX complex       For prophylaxis and treatment of
                        hemophilia B bleeding episodes and
                        other bleeding disorders and for
                        warfarin (anticoagulant) reversal

Hepatitis B immune      For passive immunization
globulin                subsequent to exposure to
                        hepatitis B

Immune globulin:        To treat agamma-and hypogamma-
intravenous and         globulinemia; for passive
intramuscular           immunization for hepatitis A and
                        measles

Plasma protein          To restore plasma volume
fraction                subsequent to shock, trauma,
                        surgery, and burns

Rabies immune globulin  For passive immunization
                        subsequent to exposure to rabies

Rho(D) immune globulin  To treat and prevent hemolytic
                        disease of fetus and newborn
                        infant stemming from Rh
                        incompatibility and incompatible
                        blood transfusions

Tetanus immune          For passive immunization
globulin                subsequent to exposure to tetanus

Vaccinia immune         For passive immunization
globulin                subsequent to exposure to smallpox

Varicella-zoster        For passive immunization
immune globulin         subsequent to exposure to chicken
                        pox
----------------------------------------------------------
Source:  Adapted from the American Blood Resources Association,
"Basic Facts About the Commercial Plasma Industry."


*** End of document. ***