DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
BLOOD PRODUCTS ADVISORY COMMITTEE
MEETING
Thursday, August 16, 2007
This transcript has not been edited
or corrected, but appears as received from the commercial transcribing
service. Accordingly, the Food and Drug
Administration makes no representation as to its accuracy.
This
meeting came to order at 8:00 a.m. in the Doubletree Hotel and
PRESENT:
DONALD W.
MARK BALLOW, MD, MEMBER
HENRY M. CRYER,
ADRIAN DI BISCEGLIE,
MD, MEMBER
WILLARDA V. EDWARDS,
MD, MEMBER
MAUREEN A. FINNEGAN, MD, MEMBER
SIMONE A. GLYNN, MD, MEMBER
KEITH C. QUIROLO, MD, MEMBER
GEORGE B. SCHREIBER, SCD, MEMBER
IRMA SZYMANSKI,
DONNA S. WHITTAKER, PHD, MEMBER
JUDITH R. BAKER, MHSA, CONSUMER REPRESENTATIVE
LOUIS M. KATZ, MD, NON-VOTING INDUSTRY
REPRESENTATIVE
MELVIN BERGER, MD, PHD, TEMPORARY VOTING MEMBER
RICHARD A COLVIN, MD PHD TEMPORARY VOTING MEMBER
JAMES R. ALLEN, MD, MPH, NON-VOTING TEMPORARY
MEMBER
T-A-B-L-E O-F C-O-N-T-E-N-T-S
Page
Statement of Conflict 4
Opening Remarks 10
Committee Updates
Summary
of May 10-11 Meeting of DHHS 11
Advisory
committee on Blood Safety and
Availability
Summary
of April 25-26 Workshop on Immune 20
Globulins
for Primary Immune Deficiency
Diseases
Summary
of August 15 Workshop on 28
Licensure
of Apheresis Blood Products
Informational Presentations: WHO Biological
Standards
Summary
of January 29-30 WHO meeting 34
Potency
and Safety Standards for Plasma 52
Derivatives
Joint
FDA/WHO Minimum Potency Standards 72
for
Certain Blood Grouping Reagents
Topic I Response to the Office of Blood Research
and
Review Office Level Site Visit
Introduction 79
Office
Response 100
Open Committee Discussion 132
Topic II Measles Antibody Levels in
Globulin
Products
Introduction 151
Current
Epidemiology of Measles in
Measles
Infections and Estimated 195
Protective
Titers
T-A-B-L-E O-F
C-O-N-T-E-N-T-S
Page
Topic II cont'd.
Measles Antibody Titers in Plasma Donors 219
Measles Antibody Levels over Time in Licensed 236
Immune
Globulin Products and Patients with
Primary
Immune Deficiency Diseases
(Baxter
Healthcare and CSL Behring)
Open Public Hearing 253
Open Committee Discussion 261
P-R-O-C-E-E-D-I-N-G-S
8:05 a.m.
EXECUTIVE
SECRETARY JEHN: Let's go ahead and get
started. Mr. Chairperson, Members of the
Committee, invited guests, temporary voting members and public participants, I
would like to welcome all of you to this 90th meeting of the Blood
Products Advisory Committee. I'm Donald
Jehn, the Executive Secretary for this meeting.
This
meeting will be completely open to the public.
At this time, I would like introduce the individuals seated at the head
table for today. To my immediate left is
our BPAC Chairperson Dr. Frederick Siegal, Medical Director of
To
my right and going down the table is Dr. James Allen, Medical Advisor, American
Social Health Association; Dr. Mark Ballow, Chief Division of Allergy and
Immunology, SUNY New York and Women's and Children's Hospital of Buffalo; Dr.
Richard Colvin, Clinical Assistant in Medicine, Center for Immunology and
Inflammatory Diseases, Massachusetts General Hospital East; Dr. Henry Cryer,
Chief of Trauma and Clinical Care at UCLA; Dr. Adrian Di Bisceglie, Chief of
Hepatology, St. Louis University School of Medicine; Dr. Willarda Edwards,
President and Chief Operating Officer of Sickle Cell Disease Association of
America; Dr. Maureen Finnegan, Associate Professor, Department of Orthopedic
Surgery, University of Texas Southwestern Medical Center; Dr. Simone Glynn,
Branch Chief Transfusion and Medicine and Therapeutics Branch, NHLBI.
And
then on my left side going down, Dr. Keith Quirolo, Clinical Director,
Apheresis Program, Department of Hematology, Children's Hospital at Oakland;
Dr. George Schreiber, Vice President of Health Studies, Westat; Dr. Irma
Szymanski, Professor of Pathology, Emerita, University of Massachusetts Medical
Center; Dr. Donna Whittaker, Chief Department of Clinical Support Services,
U.S. Army Medical Department Center and School, Fort Sam, Houston; and Ms.
Judith Baker, our Consumer Rep located at UCLA; and, finally, our Industry Rep,
Dr. Louis Katz, Executive Vice President, Medical Affairs, Mississippi Valley
Regional Blood Center.
Committee
members not in attendance are Drs. Cooner, Kulkarni, Manno and Quinn. Dr. Allen is at the table for the discussion
of the response of the Office of Blood, Research and Review Office Level Site
Visit for Research. I would like to
thank all of you for attending this meeting.
Now
if I could have Dr. Goodman. We have
four retiring members after this meeting and we would like to recognize
them. Dr. Szymanski.
(Applause.)
EXECUTIVE
SECRETARY JEHN: Dr. Donna Whittaker.
(Applause.)
EXECUTIVE
SECRETARY JEHN: Dr. Keith Quirolo.
(Applause.)
DR.
WHITTAKER: And Dr. George Schreiber.
(Applause.)
EXECUTIVE
SECRETARY JEHN: We thank them all. Thanks very much.
Okay. Before we start the meeting, I do have a
conflict of interest statement to read.
It's rather lengthy, so please bear with me.
The
Food and Drug Administration, FDA, is convening today's meeting of the Blood
Products Advisory Committee under the authority of the Federal Advisory
Committee Act, FACA, of 1972. With the
exception of the Industry Representative, all participants of the Committee are
special government employees, SGEs, or regular federal employees from other
agencies and are subject to the Federal Conflict of Interest laws and
regulations.
The
following information on the status of this advisory committee's compliance
with Federal Ethics and Conflict of Interest laws including, but not limited
to, 18 USC Section 208 and 21 USC Section 355(n)(4) is being provided to
participants in today's meeting and to the public. FDA has determined that participants of this
advisory committee are in compliance with Federal Ethics and Conflict of Interest
Laws including, but not limited to, 18 USC Section 208 and 21 USC 355
(n)(4). Under 18 USC 208 applicable to
all government agencies and 21 USC 355(n)(4) applicable to certain FDA
committees, Congress has authorized FDA to grant waivers to special government
employees who have financial conflicts when it is determined that the Agency's
need for a particular individual's services outweighs his or her potential
financial conflict of interest, Section 208, and where participation is
necessary to afford essential expertise, Section 355.
Members
of the Committee who are special government employees at today's meeting
including special government employees appointed as temporary voting members
have been screened for potential financial conflicts of interest of their own
as well as those imputed to them, including those of their employers, spouse or
minor child related to the discussion of (1) FDA's response to the Officer of
Blood Research and Review Office Site Visit held on July 22, 2005 and (2)
measles antibody levels in U.S. immune globulin products. These interests may include investments,
consulting, expert witness testimony, contracts, grants, CRADAs, teaching,
speaking, writing, patents and royalties and primary employment.
Today's
agenda also includes several updates. In
accordance with 18 USC Section 208(b)(3), waivers were granted to Dr. Mark
Ballow and Dr. Melvin Berger for the discussion of topic two on Measles
Antibody Levels in U.S. Globulin Products.
A copy of the written waiver may be obtained by submitting a written
request to the Agency's Freedom of Information Office, Room 12A-30 of the
With
regard to the FDA's guest speakers for Topic two, the Agency has determined
that the information provided by these speakers is essential. The following information is being made
public to allow the audience to objectively evaluate any presentation and/or
comments made. Dr. Donald Baker is
employed by Baxter Healthcare Corporation.
Dr. Baker has financial interests in his employer. Dr. William
Moss is employed by Johns Hopkins Bloomberg's
In
addition, there may be regulated industry and other outside organizations'
speakers making presentations. These
speakers may have financial interests associated with their employer and with
other regulated firms. The FDA asks in
the interest of fairness that they address any current or previous financial
involvement with any firm whose product they may wish to comment upon. These individuals were not screened by the
FDA for conflicts of interest.
Dr.
Louis Katz is serving as the Industry Representative acting on behalf of all
related industry and is employed by the
This
conflict of interest statement will be available for review at the registration
table. We would like to remind members
that if the discussions involve any other products or firms not already on the
agenda for which an FDA participant has a personal or imputed financial
interest, the participants need to exclude themselves from such involvement and
their exclusion will be noted for the record.
The FDA encourages all other participants to advise the Committee of any
financial relationships that you may have with any sponsor, products, direct
competitors and firms that could be affected by the discussions.
Before
I turn the microphone over to the Chair, I would like to request that everybody
take a moment and check to make sure they have their cell phones and pagers set
to silent or turned off. Thank you. Dr. Siegal, I'll turn it over to you.
CHAIRMAN
SIEGAL: Thank you, Don. I would like to welcome you all to this
glorious summer meeting of the Blood Products Advisory Committee. Fortunately,
we don't have a lot of controversial topics, but we have a fair amount to
cover. I particularly want to welcome
back Jim Allen, an old friend from the AIDS wars. Can you not hear me? Well, it's not really important anyway.
(Laughter)
CHAIRMAN
SIEGAL: But Jim was, of course, my
predecessor on this committee and we've known one another since about 1981
maybe.
Our
first set of topics are the Committee updates and we're going to start with
Jerry Holmberg who is going to review and summarize the meeting of the DHHS
Advisory Committee on Blood Safety and Availability. Jerry.
DR.
HOLMBERG: While we are waiting to get
that up on the screen, I'll just give you a little disclosure. I do have financial interests in my company,
the Federal Government, and that financial interest is not only receiving a
salary, but paying taxes.
(Laughter.)
DR.
HOLMBERG: And if anybody would like to
know, I have had my annual financial review with the Ethics Office.
What
I would like to do today is to give you an update on the Advisory Committee on
Blood Safety and Availability and the Office of Blood Safety and Availability
and also primarily give you a summary of the May 10 and 11, 2007 meeting.
First
of all, I would like to note that we have some staff changes. The biggest staff change that I would like to
mention that is not on the slide here is that Dr. Aquinobi, the Assistant
Secretary for Health, has resigned from the Administration and that resignation is as effective as of September 3rd. In my office, we do have Lt. Commander Rich
Henry who has moved up to the Deputy Director position and we have a new Public
Health Officer, LTjg Jennifer Lunney who is our Senior Health Preparedness
Advisor.
At
the May 10th and 11th meeting, Dr. Aquinobi asked the
committee to review several commonalities between transfusion and
transplantation safety. The reason for
that is in October the charter for the Advisory Committee on Blood Safety and
Availability was modified to include interests or concerns of transfusion and
transplantation safety. This sort of
opens up the scope of issues that we can deal with at the committee and Dr.
Aquinobi was looking to see are there areas of commonality.
So
the first question was is there a process, an opportunity, to lay out a process
for transfusion and transplantation safety for the future and the committee
overwhelmingly said that, yes, there is a need to develop a process to enhance
the quality and improvement in transfusion medicine and transplantation
medicine.
Is
there scientific evidence to support a need for a master strategy? In this particular area, the committee really
struggled as far as finding scientific evidence, but based on surveillance
evidence there is a limited reports of infectious disease transmission and
therefore, substantiate the need for a master strategy and you can read on
there as far as the differences in the risk/benefit profiles between
transfusion tissue and transplantation recipients but that all these patients
have the potential for acquiring life-threatening infections if an infectious
disease screening is flawed or emerging or unknown diseases evolve unchecked
over time.
So
another question that was asked was what should be the scope of a master
strategy and the number one issue that came out was a recipient outcome
surveillance or a biovigilance system to identify all donors using common
identification numbers linked to biological products that are uniquely
identified; mandatory adverse event reporting process for tissues, organs and
blood therapy through appropriate mechanisms to designated public health
authorities and to recipients and donors and timely and efficiently trace all
biological products to the clinical user, recipient, and donor and to recognize
transmissible events resulting in adverse outcomes including infectious agents,
malignancies and toxins; also to build communication and education networks to
disseminate data to users; to develop informatics to support surveillance,
process, involvement, improvement and evidence-based research; and to include
other strategic plan elements as needed such as donor recruitment, donor
screening, research coordination and emergency preparedness.
What
are the areas of commonality of blood products, cohort progenitor cells and
bone marrow tissues and organs? Key
elements in common with transfusion required for ensuring high quality include
donor recruitment; donor screening; and, of course, eligibility; collection;
infectious disease testing; transportation; storage; processing; labeling;
traceability; good manufacturing practices; good tissue practices. I would also say probably good
transplantation practices; outcome analysis; adverse event reporting. And in addition, there needs to be a way to
evaluate the differences between the different transfusion and transplantation
products, modalities.
How
best should this be done with the stakeholders and how do we begin? The recommendation was that HHS should
convene a forum of stakeholders to include public health agencies, accrediting
agencies, manufacturers, clinicians, consumers and endusers and HHS should be
responsible for implementing a master strategy with appropriate resources based
on input from stakeholders.
And
what are the resources needed and what are the estimated costs? The committee really do not get to that area
and had a difficult time trying to put a price tag on what this would mean.
Let
me just go back to that slide there. As
an outcome of the recommendations, Dr. Aquinobi has sent a letter to Dr. Bracey
who is the Chairman of the Advisory Committee on Blood Safety and
Availability. In that letter, he does
recognize the recommendations and the answers to the questions and also
reassures Dr. Bracey that the Department has already moved forward in various
aspects on bioviligence and we have already put resources towards those
bioviligence endeavors through not only the recipient side but also through the
donor side of surveillance and also CDC is supporting a collaborative effort
with the TTSN for tissues and transplantation.
Our
next meeting is next week. The two
issues that we're primarily looking at ethical considerations and risk benefits
for ensuring transfusion and transplantation safety during focal periods of
shortages. Those focal periods of
shortages could be seasonal shortages, preparation for pandemic, disasters both
manmade or natural and then also to review and discuss the elasticity of the
blood supply to support transfusion and transplantation safety as well as
strategies and barriers to those strategies.
And
that's all I have. If there are any
questions, I'll be happy to entertain those.
CHAIRMAN
SIEGAL: Questions from the Committee?
DR.
FINNEGAN: One of my questions and I
realize I'm a little bit naive about what the infrastructure for IT is within
this environment, but would you consider having IT infrastructure as one of the
stakeholders? Because it would seem to
me if you had a good IT infrastructure, that the cost long term would be much
less.
DR.
HOLMBERG: Absolutely. We have already initiated some of those
discussions primarily using some of the infrastructure that is already in place
within the Federal Government and outside the Federal Government. Also within the Department of Health and
Human Services is a health information technology office that is personally --
that reports directly to Secretary Leavitt.
They've done case studies analysis for electronic health records and
also for laboratory surveillance.
So
we're moving in that direction, but, yes, definitely in our stakeholder
meetings, we will consider IT so that there are stakeholders, there are
placeholders, I should say, for future systems that are developed that we can
mine the data down into.
The
other thing that I want to emphasize there is that we are really looking at
this as a quality system in such a way that this will be a system to develop or
to get data that we can analysis in hopes of being able to share it throughout
the entire community and not to be punitive against a stakeholder. So it's trying to be very open in the way we
collect the data and for that reason, we have already involved many of the
stakeholders such as the AABB and the UNIS and the various -- the American
Association of Tissue Banks. Yes. Dr. Ballow.
DR.
BALLOW: So is this to include all
fractionated blood banks as well?
DR.
HOLMBERG: Well, we do have them --
DR.
BALLOW: Coagulation products, IV, IG,
etc.?
DR.
HOLMBERG: We do have them as one of the
stakeholders and we have not had the meeting yet, but they are on the list to
participate.
The
other thing I want to draw the attention to is that we do have a federal
registry notice out that came out on July 30th seeking nominations
to the Advisory Committee on Blood Safety and Availability. I would like to take this opportunity to draw
your attention to that and to remind people that nominations are due by August
31st.
Thank you.
DR.
SZYMANSKI: I had one more question. I notice an interesting word
"malignancy" and how are you going to screen for that? In donors or in the recipients? Is that something new that is not being done
now when you screen donors?
DR.
HOLMBERG: I didn't understand the word
that you were referring to.
DR.
SZYMANSKI: You said you are going to not
only worry about infectious diseases, but transmission or something with
malignancy and I was wondering. Do you
have any other approaches than what are used right now when you screen donors
for blood donation?
DR.
HOLMBERG: As far as blood donations, we
do not have a mechanism to be able to track that. However, in the organ community they do have
the adverse event reporting and that does get passed back to UNIS. But it's open. We're the point right now of just developing
this and, of course, as we move forward in bioviligence, I'm sure there will be
other avenues that we want to investigate.
I think that what he want to do is to not only look at what we know
today but also to look towards the future and to be able to look beyond the horizon
for anything that may potentially affect the blood organ or tissue products.
CHAIRMAN
SIEGAL: Are there any other questions
for Dr. Holmberg? Okay. If not, Jerry, thank you. The next speaker will be Jennifer Scharpf who
is going to review the FDA workshop from last April on immune globulins for
primary immune deficiency disease referencing antibody specificity, potency and
testing. Dr. Scharpf.
DR.
SCHARPF: Thank you, Dr. Siegal, and good
morning. This morning I will provide the
Committee on the FDA's workshop on immune globulins for primary immune
deficiency diseases and the workshop was officially titled "Immune
Globulins for Primary Immune Deficiency Diseases; Antibody Specificity, Potency
and Testing." And the workshop was
held on April 25 through 26 of this year at the National Institutes of
Health. FDA is grateful to The Immune
Deficiency Foundation, The Plasma Protein Therapeutic Association and Dr.
Holmberg and the Office of the Secretary, Office of Public Health and Science
at HHS for their sponsorship of the workshop.
And we thank the sponsors not only for their financial support but also
their scientific contributions to the program.
Additionally, I would like to recognize Dr. Dorothy Scott for her role
as organizer and chair of the program.
The
goals of the workshop were fourfold: (1)
to assess the current potency testing of immune globulins. The potency tests currently required are for
antibodies to measles, polio and diphtheria and at the workshop, we wished to
examine the potential for potency tests for antibodies against pathogens most
commonly associated with infection in PIDD patients; (2) to list antibodies
needed to protect primary immune deficient patients from infections; (3) to
identify candidate antibody specificities for potency testing of immune
globulins for treatment of PIDD; and, finally, on the second day, our goal was
to address approaches to diminishing measles antibody levels in currently
licensed products.
So
on the first day of the workshop, our goal was to identify the most clinically
relevant antibody specificities for PIDD patients. Epidemiology and surveillance data was
reviewed and there was a description of patient registries in Europe and the
The
first question we addressed to the panel of experts and the workshop audience
was which pathogens are of greatest concern in immune globulin treated and
untreated patients. And to address this
question, data on infectious diseases and PIDD, both patients with humeral and
cellular immunodeficiencies was presented by clinicians.
The
workshop participants identified Strep pneumococcus and Haemophiles influenzae
as the most important bacterial infections for this patient population. Several viral infections were also mentioned
as pathogens of concern including Epstein-Barr Virus, Cytomegalovirus,
echoviruses, Varicella Zoster, adenovirus and Coxsackie.
Representatives
from the FDA, the Paul-Ehrlich-Institut in
So
at the end of the first day of the workshop, it was proposed that pilot testing
of immune globulins for Strep pneumonia and H. influenza should be conducted
and we believe this type of study is feasible since assays have been validated
for the specificities in serum and who reference labs already exist to which
samples could be sent for testing.
In
the proposed studies, manufacturers would voluntarily send blinded samples to
their reference lab for testing antibody levels to determine the feasibility,
antibody levels and function, and several manufacturers have expressed their
willingness to send samples. And
finally, we would like to measure the trough titer level antibodies to these
bacterial pathogens in patients receiving the product to determine the
relationship between in vitro potency and in vivo levels. And we anticipate that by working with
manufacturers, samples from clinical studies would be available for this type
of testing.
On
the second day of the workshop, we discussed the current lot release tests for
measles antibodies and measles antibody levels are a standard lot release
measure of potency in the
The
regulatory impact of declining measles titers is that the product could fail
the lot release specification and the specific lots must be rejected and
rejection of lots could lead to an obvious negative impact on the availability
of the product for the primary immune deficient patients.
Presentations
at the workshop revealed data on the measles epidemiology in the
Following
those presentations, we asked the following questions to the expert panel and
the audience: is measles infection of
current clinical concern for primary immune deficient patients, how much
measles antibody is needed to attenuate or prevent measles in this patient
population; what is the potential clinical impact of diminishing anti-measles
titers in immune globulin products; and finally, what are the possible
approaches to address the decline of anti-measles antibodies in immune
globulins with respect to clinical efficacy in prevention of measles infection
as well as with respect to utility of a test for lot-to-lot consistency.
So
the possible approaches identified by the discussants at the workshop included:
(1) gathering relevant data relating product titers to patient trough levels
and estimated protective levels and (2) the option that CBER can potentially
change the recommendation on antibody potency, however, this change in level
must be scientifically and clinically justifiable and this is the issue that
will be before the Committee today.
So
in summary, the next steps identified at the workshop are to (1) design and
implement testing protocols to assess levels of antibodies in immune globulins
to H. Influenza and Strep pneumonia pathogens commonly associated with infection
in primary immunodeficient patients and the study will evaluate the feasibility
of using these specificities as potency tests; (2) implement a study to measure
measles antibody trough levels by neutralization assays in patients to better
ascertain the relationship between product dose and trough level; and finally,
CBER will deliberate on solutions to address the diminishing measles antibodies
titers and immune globulins weighing, of course, the scientific, clinical and
supply considerations.
And
finally, information is available on the CBER website including the transcript
and all of the workshop presentations.
Thank you for your attention.
CHAIRMAN
SIEGAL: Thank you, Dr. Scharpf. Are there questions from the Committee? I actually do have a question which is that
since we will discuss this later but is it feasible to change the licensure
requirements entirely so that measles antibody which may not really be relevant
is simply not part of the criteria for approval of the product.
DR.
SCHARPF: I think we can look at
examining changing the titer and that's what we will present later this
afternoon to the Committee.
CHAIRMAN
SIEGAL: Because it certainly would be
more relevant to look at representative pneumococcal antibody titers for the
PIDD population.
DR.
SCHARPF: And that was some of the
conclusions of the workshop.
CHAIRMAN
SIEGAL: Anybody else?
DR.
GOLDING: Yes, I'll just help to answer
that question. I mean we are looking
very actively at changing this, the relevant titers, and what Jennifer
mentioned is that we're looking at H. influenzae and also at Strep pneumoniae
as being much more important and relevant pathogens. But I don't think we have any plans in the
near future to drop measles because as you will hear later, we still think this
is a pathogen we need to worry about even though it's much rarer these
days. But also in terms of consistency
of lot-to-lot testing, it's important to have tests in place that have the
history and the ability to show differences between batches.
CHAIRMAN
SIEGAL: Okay. Let's move on. Finally, Lore Fields from FDA is going to
summarize the FDA workshop just yesterday on licensure of apheresis blood
products.
MS.
FIELDS: Good morning. Yesterday we had a workshop on the licensure
of aphersis blood products at Lister Hill Auditorium at NIH.
In
keeping with the vision of CBER to protect and improve public health and to
approve safe and effective blood products, we planned a workshop to help
educate industry on how we approve apheresis submissions at the Blood and
Plasma branch. We estimate that
currently appropriately 40 percent of the submissions coming into the Blood and
Plasma branch are on apheresis products.
We did have 175 places available yesterday for the workshop and we did
fill the entire auditorium.
The
goals and objectives for the workshop were to educate industry on the licensure
process for apheresis platelets, red blood cells and plasma for
transfusion. We wanted to discuss the
managed review process as it applies to the Blood and Plasma branch, discuss
and review the required documents needed for submission, review the
comparability protocol and what is required to obtain one and review the
requirements for an apheresis instrument.
Additionally, we asked speakers from industry to give examples on how
they successfully submit their FDA's licensure submissions. We also asked Dr.
Katz from the
The
workshop was developed and cosponsored by CBER, the Department of Health and
Human Services, AABB and
During
the workshop, we had several presentations.
I'm going to go over just very brief overviews of what was
discussed. Dr. Goodman did open the
workshop for us.
Dr.
Williams provided an informative presentation on the statutes and regulations
that we use to do licensure submissions.
Dr. Williams also covered licensing, changes to an approved application,
alternative procedures and how managed review is applied to the Blood and Plasma
branch.
Ms.
Ciaraldi did a comprehensive presentation that described how we perform
reviews. This presentation included the
documents, regulations, guidance and operators' manuals references that we
frequently use when we are doing our reviews.
Ms.
Nesbitt did a top ten pitfalls with submissions presentation and what we did
with this was he got together in the Blood and Plasma branch and we came up
with the top ten reasons that we find errors in submissions and she went
through them. Hopefully, the blood
centers will then be able to apply this to their submissions before they send
them in and it will facilitate the process of getting licensure done in a timely manner.
The
next two presentations were given by representatives of the American Red Cross
and Blood Systems. We are always being
asked for examples of acceptable submissions.
So we asked these two blood centers to provide the attendees with an
overview of their processes.
Steve
Kassapian who is the Director of Regulatory Affairs at American Red Cross
reviewed his processes and included some of the examples and forms that his
group has put together over the last couple of years that they use to
facilitate their process.
Ms.
Kathleen Hopping from BSI reviewed how they have standardized their platelet
Apheresis licensure process. She also
provided the attendees with timetables on how the process improvement has
reduced the time of the licensure or the approval for licensure at their blood
centers.
I
went over a brief review of the current guidance for platelet Apheresis and the
2005 draft guidance.
We
did have an unexpected presentation yesterday that is unfortunately not on your
slides. A direct final rule was actually
displayed yesterday as well. So we had a
surprise presentation by Ms. Elizabeth Callahan who is the Acting Director of
the Division of Blood Applications and in this is the changes that will allow a
storage period of seven days for platelet Apheresis and also the increase for
the minimum pH from 6.0 to 6.2 for platelet Apheresis quality control.
Dr.
Katz put on a presentation based on the comments to the 2005 draft
guidance. His group did a study to
determine what the impact is on platelet counts and donation intervals. This is the data that was previously
presented to you in March of 2006. The
paper was recently published and so we asked him to present the data to the
attendees.
The
failure investigation presentations covered the regulations behind the
investigations by Ms. Hoi-may Wong and also one example of how a structured
investigation process is working at a major blood center.
Ms.
Faye Kugele described how the ARC has standardized their failure investigation
processes and how the standardized procedures have improved their investigation
of failed products.
We
did something a little different at our workshop and one of the things is we
spent a lot of time talking to the regulatory people at the blood centers, but
they never actually see our faces. So we
spent about 30 minutes at our afternoon break kind of introducing ourselves to
them so they had a face to go with the person that they talked to.
The
Device Manufacturers Forum was an opportunity for the manufacturers to provide
the attendees with pertinent information from their operators' manuals, package
inserts and other documents that should be included with their submission. They also provided updates on recent changes
on their cleared devices and this was done by Merilyn Wiler from Gambro, Dr.
Orton from Fenwal and Sue Finneran from Haemonetics.