Part
3: The FDA Ruling
& Donor Eligibility
This is part 3 in a multi-part series concerning
the
new FDA regulations affecting the fertility field.
In
the final part of this three part series, we would
like to address more of the specifics of donor
eligibility as well as discuss where we go from
here.
Overview of Donor Eligibility:
When
it comes to determining whether a donor is eligible
to donate their reproductive tissue, there are
several general elements to address:
1) Donor eligibility determination:
The FDA requires that before a donor can donate
their tissue, a “responsible person”
must determine whether the donor is eligible.
All the information that is collected on the donor
is reviewed at some point and the donor is determined
to be “eligible” or “ineligible”
to donate. Regardless of whether the donor is
anonymous or directed (known), this MUST be done
and records of this must be kept.
2) Information necessary
for a donor eligibility determination:
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a.
Screening results:
The donor must be screened appropriately for
the relevant communicable diseases (as defined
by the FDA). This can be broken down into
a few categories:
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i.
Donor questionnaire (could contain FDA-specific
questions as well as clinic-specific
questions)
ii. Physical exam
iii. Medical records review
iv. Any other information deemed necessary
for determining donor eligibility status |
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b.
Testing results:
These are the FDA-approved or cleared tests
that are specific for the relevant communicable
diseases stated in the ruling and the draft
guidance. |
All of the testing results and medical records are
used together by the responsible person for the
donor eligibility review. All of the appropriate
screening questions and testing must occur within
30 days of the egg retrieval in a donor egg cycle.
Donor sperm, however, has a 7-day window requirement.
Diligent recordkeeping is required every step of
the way and policies and procedures must be written
and kept on-site. Establishing a quality assurance
program that regularly prescribes internal (and
possibly external) audits is also a good idea. Of
course, there are also many more detailed and specific
requirements stated in the ruling concerning accompanying
records, summary of records, quarantine, labeling,
and shipping requirements. The details are numerous
and beyond the scope of this article.
Finally, if there is a question of whether a particular
piece of documentation needs to occur, then it may
be helpful to remember that, “if it isn’t
documented, then it didn’t happen!”
Where do we go from here?
From a public health standpoint, the changes that
are required to take place for determining whether
a donor is eligible to donate their reproductive
tissue (i.e. eggs, sperm, and embryos) are intended
to increase the safety of the tissue available during
a donor situation.
However, there has been much debate as to whether
there were any public health issues concerning donor
reproductive tissue prior to the FDA ruling. This
debate will probably be ongoing for years to come
and will not be answered easily.
What is certain is that the new FDA ruling influences,
at least in some way, how fertility practices, donor
agencies, sperm banks and clinical testing facilities
screen, test and determine whether a donor is eligible.
The ruling also affects recipients of donated eggs,
sperm and embryos. For instance, there was a very
positive change that recently occurred in the Interim
Final Rule the FDA published the day before the
regulations went into effect that allows for more
leniency in embryo donation compared to what the
original ruling stated.
Even with the FDA making updates and changes as
time goes on, we can be sure that some form of governmental
regulation of the fertility field is here to stay.
The question we need to ask ourselves now is: How
do we—as patients, practitioners and support
personnel—help the FDA and the government
gain enough knowledge and understanding so that
they make effective and reasonable decisions regarding
fertility issues? That’s one question we all
need to think about.
This
article is merely an interpretation of the FDA
ruling
and cannot take the place of the actual regulations.
Wendy
D. Latash, Ph.D.
Jade Tree Solutions, LLC
www.jadetreesolutions.com
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Orwellian…
or Not?
In 1998, when I first started working in the field of third
party reproduction, many Intended Parents saw egg donation
as an “Orwellian” experience. Over time, perceptions
have changed and many infertile couples have accepted ovum
donation as a wonderful opportunity and are now enjoying being
parents. Today, some Intended Parents in their 40’s
are going directly to a donor cycle to avoid the emotional
and financial trauma of an unlikely positive outcome doing
an IVF cycle with their own eggs. Still, for many, the idea
of ovum donation remains an “Orwellian” idea despite
the hope it would offer them to achieve their dream of creating
a family.
 It
can be a rude awakening when a woman finds out that her egg
quality and viability starts to diminish at age 30 and then
even more rapidly after age 35. By the time most women are
40, the decline is quite dramatic. Beyond age 40, a woman’s
chance of achieving a viable pregnancy with her own eggs is
in the single digits. The good news for Intended Parents is
that the chances of having a healthy pregnancy and live birth
increase dramatically from, at best, 5% using their own eggs,
to at least 50% when working with a donor. There is always
the hope that the statistics won’t apply to “me,”
but reality is that ovarian function declines with age and
sometimes donor eggs are the best solution.
Celebrities
having children into their 40’s and beyond have exacerbated
this fantasy. The façade is that celebrities
make up that small percentage of women over 40 who can still
conceive without an ART procedure or a donor egg. A more likely
reality is that they are keeping quiet about how they have
formed their families. It would appear that their intentions
are to protect their family’s privacy, a right we are
all entitled to. Unfortunately, the sad result is that the
general population of women over age 40 look to these celebrities
as a beacon of hope. The prevailing attitude becomes, “If
a celebrity can have a baby at 50, so can I.” This false
pretense keeps ovum donation “Orwellian,” when
in reality, thousands of families are formed every year through
third party reproduction.
Some
factors to consider when using third party reproduction:
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Your child is a creation of your love relationship.
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You
have the opportunity to feel a life grow inside of you.
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You
nourish your child with your blood.
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You
alone are the mother. The donor signs a contract declaring
she has no rights to any child, embryo or eggs.
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Donors
don’t view their donation as a child, but rather as
a donation of tissue to make your child possible.
Couples
who have formed their family through egg donation that are
willing to speak about their experiences are doing a tremendous
service to help those couples that are still feeling isolated
in their infertility. They are helping couples both now and
in the future that may need some form of Assisted Reproductive
Technology to build their family. I applaud them and the handful
of celebrities who are willing to reveal their stories giving
hope to many in similar situations.
Gail
Sexton Anderson
The Donor Source
www.thedonorsource.com
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