Reinventing the Regulation of Human Tissue

P97-8                          Food and Drug Administration
FOR IMMEDIATE RELEASE          Lenore Gelb:     (301) 443-3285
February 28, 1997              Broadcast Media: (301) 827-3434
                   Consumer Hotline:(800) 532-4440


The Food and Drug Administration today announced a plan for a
new, comprehensive regulatory framework for products derived from
cells and tissues that would protect the public health through
innovative common-sense government oversight.  Today's proposal is
the FDA's sixth reinvention reform as part of the Clinton
Administration's Reinventing Government Initiative.

"This new regulatory framework, developed after discussions
with industry, academics and professional groups, will allow
greater flexibility and innovation in this promising field of
medicine," said Vice President Al Gore. "At the same time,
safeguards are maintained to protect the public health."

"Human tissues have wide uses in medicine, including skin
replacement after severe burns, tendons and ligaments to repair
injuries, and corneas to restore eyesight,"  said HHS Secretary
Donna E. Shalala. "Now that science is providing even more new ways
of using tissues, FDA has developed an innovative regulatory
approach to allow these novel products to benefit patients as soon
as possible."

In recent years, scientists have developed innovative methods
of manipulating and using human cells and tissues for therapeutic
purposes.  For example, using somatic cell therapy, scientists are
studying how to manipulate and use human cells to treat viral
infections (including HIV), Parkinson's disease, and diabetes. 
Other tissue research includes the treatment of diseases and
medical conditions by using "cord blood" (from the placenta and
umbilical cord) and processed structural cells and tissues.  

This new regulatory framework, which provides a tiered
approach with the level of regulation proportionate to the degree
of risk, focuses on three general goals:

The following examples show how the tiered approach would

FDA's current regulation of unmodified or minimally modified
tissues that traditionally have been used for replacement purposes
(such as bone replacement) focuses on preventing the spread of
communicable disease.  In December 1993, FDA issued an interim
final rule that required the testing of tissue donors for certain
transmissible disease such as HIV infection and hepatitis, as well
as the screening of donors for behavioral risk factors.  FDA
intends to finalize these requirements soon.  The requirements for
this new regulatory framework would be phased in over the next two
to three years.

The new regulatory framework does not include whole organs or
minimally-manipulated bone marrow, which are both regulated by the
Health Resources and Services Administration.  It does not cover
blood products -- such as whole blood, red blood cells, platelet
and plasma -- for transfusion or animal-derived tissues, which FDA
regulates under existing authorities.  Additional products covered
by other regulations and standards include human milk, collagen,
and growth factors.

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