Monday, January 29, 1996
WASHINGTON - With the comment period winding
toward a conclusion next month, FDA Commissioner David Kessler last week signaled
that the agency will adopt a "flexible approach" to the regulation
of autologous cell transfers.
The debate over regulation of autologous transfers was sparked by FDA's decision last
April to regulate Genzyme Corp.'s Carticel process, which involves autologous
transplantation of cartilage to treat knee injuries, under provisions it uses to regulate
somatic cell transfers. The company protested and the agency decided to allow the
procedure to be used without regulation pending resolution of wider issues related to
autologous cell transfers.