HHS NEWS

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

           REINVENTING THE REGULATION OF HUMAN TISSUE

     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), Parkinsonþs 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: 
*    preventing the unwitting use of contaminated tissues with the
     potential for transmitting infectious diseases; 
*    preventing improper handling or processing that might
     contaminate or damage tissues; 
*    and ensuring that clinical safety and effectiveness are
     demonstrated for certain cells and tissues.  These include
     highly processed tissues, as well as those that are used for
     other than their normal purposes, those that are combined with
     non-tissue components, and many that are used for metabolic
     purposes (such as to treat diabetes).  
     This tiered approach will impose little or no regulation for
some products, with the degree of oversight increasing with the
potential risk, so that extensively  processed and novel products 
would require FDAþs approval before they could be marketed.  All
tissue processing facilities would be required  to register with
the FDA and to list their products, and all labeling and promotion
of these products would have to be clear, accurate, balanced, and
non-misleading.  
     In designing this new approach, FDA focused on five broad
public health and regulatory questions: (1) How can the spread of
communicable diseases be prevented?  (2) What processing controls
are needed to prevent contamination and preserve the integrity of
cells and tissues?  (3) How can clinical safety and effectiveness
be assured? (4) What labeling is necessary, and what kind of
promotion is permissible, so that the product may be used properly?
and (5) How can FDA best monitor and communicate effectively with
the cell and tissue industry?
     The following examples show how the tiered approach would
work:
*    FDA would not regulate cells and tissues removed from and
     transplanted into the same person in a single surgical
     procedure.
*    For most conventional and reproductive tissues that are
     minimally processed and used for their normal functions, FDA's
     oversight would focus on proper handling and on ensuring that
     the products are not infectious.  
     Registration, product listing, and adverse event reports     
     would be the only submissions required.
*    FDA would require that all tissues (except those removed and
     transplanted back into the same patient in one surgical
     procedure) be handled according to þgood tissue practices.þ 
     FDA would also prescribe procedures for testing the tissue for
     infectious agents and screening the donor about potential
     exposure to disease agents.
*    For tissue stored for use in the same person from whom it was
     obtained (or in a sexually intimate partner of a reproductive-
     tissue donor), FDA would recommend but not require that
     similar testing and screening procedures be followed.  To
     protect health care workers, FDA would also require labeling
     according to whether the tissue poses a potential biohazard.
*    For most tissue transplanted from one person to another, FDA
     would require infectious disease testing, donor screening, and
     processing controls.
*    For some tissues, FDA would require controlled clinical trials
     and pre-market approval to demonstrate safety and
     effectiveness.  This requirement would apply to tissues and
     cells processed to alter their biological or functional
     characteristics; tissues and cells used to perform other than
     their normal functions; many tissues and cells used for      
     metabolic purposes; and tissues and cells that are combined
     with medical devices, drugs, or other biological products. 
     Somatic cell therapy and gene therapy would be covered by this
     category of regulation, as would many forms of stem cell
     therapy.
     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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