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Gail Sexton Anderson
The Donor Source
www.thedonorsource.com
Part
2: A Breakdown of the FDA ruling
This
is part 2 in a multi-part series concerning the
new FDA regulations affecting the fertility field.
Even
though it’s been a little over a month since
the new FDA regulations have taken effect, there
is still confusion on how the regulations affect
the fertility field. Although we cannot provide
you with the definitive answer to every question
you may have, we will attempt to provide some
useful information that will start to give you
an idea of the bottom line.
This
month we will focus on three aspects of the regulations
to pay attention to:
| •
|
Who
needs to register with the FDA? |
| •
|
How
different facilities subject to this ruling
interact? |
| •
|
What
does the FDA mean by “screening”
and “testing”
and how do the requirements apply? |
FDA
Registration:
All facilities that “...recover, process,
store, label, package, or distribute any HCT/P,
or screen or test the HCT/P donor...” must
register with the FDA and renew that registration
every December. There are a few exceptions, but
they are limited.
Practically
speaking, not all of this applies. It is apparent
that all fertility practices that perform IVF
and deal with any kind of reproductive donor tissue
MUST register. It seems that other facilities/companies
that support the fertility field may have to as
well.
Interacting
with outside agencies:
The FDA requires that “before entering into
a contract, agreement, or other arrangement with
another establishment to perform any step in manufacture
for you, you must ensure that the establishment
complies with applicable CGTP requirements.”
This has caused confusion as to whom this applies
to and under what circumstances.
Many
are interpreting this to mean that any support
facility for the fertility field (i.e. sperm bank,
donor agency, long-term cryostorage facility,
clinical testing laboratory) is subject to this
part of the ruling. A number of fertility practices
are making attempts at acquiring information from
these facilities to determine whether they follow
FDA regulations and some have already taken steps
to inform their clients that they are compliant.
The
Difference between “Screen” and “Test”:
Many in the field have different meanings for
the terms “screening” and “testing”
and the FDA does make a distinction between them.
From the regulations, it seems that:
“Screening”
a donor is the process of administering questionnaires,
performing physical assessments and reviewing
any medical or other pertinent records of a donor
to determine if there are any risk factors for,
or clinical evidence of relevant communicable
diseases. This distinction is important since
the FDA requires that donors be “screened”
for the potential exposure to certain diseases
that currently cannot be tested for using FDA-approved
tests.
“Testing”
a donor is the process of obtaining blood samples
or cultures, testing the samples with FDA-approved
or cleared tests performed by a “certified”
clinical laboratory, and obtaining results as
to what those tests showed in terms of relevant
clinical disease(s). As more tests become approved
by the FDA (i.e. West Nile Virus, SARS), keep
in mind that the FDA may require those tests to
be added to the current list of diseases for which
donors must be tested.
Resources:
For further information, go to the FDA website
to look through the different rulings and guidances
they have published. Here is a good place to start:
http://www.fda.gov/cber/tiss.htm
The
links to “Tissue Registration” and
“Publications” will have important
information on registration and the actual FDA
rulings and guidances that have been published.
As
a regulated facility, there are independent companies
that can help you with your FDA compliance issues
as well.
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
|
Although many donors may be initially attracted by money,
most follow through for more altruistic reasons. Ovum donorship
attracts women who are bright, and many have researched on-line
or through friends to determine if egg donation is a good
choice for them. This is reinforced by the psychological evaluation
that donors are required to have prior to going through an
egg donation cycle. The consensus among psychologists is that
egg donors are usually of superior intelligence and are delightful,
engaging young women who want to help a couple in need. 
