January 3, 2000
Ms. Ilsa Demby Barber
28 Taylor Terrace
Colonia, New Jersey 07067
Dear Ms. Barber:
Thank you for contacting me regarding the
use of beef insulin to treat diabetes. I
appreciate your interest in this issue, and
I welcome the opportunity to respond.
As you know, along with human insulin and
pork insulin, beef insulin is used to
control the symptoms of diabetes. In the
U.S., beef insulin was until recently
produced and sold by Eli Lilly.
Unfortunately Eli Lilly has discontinued
marketing Iletin-1, a combination beef-pork
insulin product. Although other types of
insulin are available in America, the Food
and Drug Administration (FDA) has not
approved insulin derived from beef for use
in this country.
While foreign manufacturers do continue
to produce and distribute beef insulin,
these products are not available to U.S.
consumers. This is due to the possible
threat of bovine spongiform encephalopathy
(BSE) or “mad cow disease”, which can be
transmitted through the beef insulin that
comes from foreign drug manufacturers. The
FDA will not approve any applications from
foreign manufacturers of beef insulin to
sell their product in the U.S. as long as
the threat of mad cow disease persists.
However, you may still be able to import
beef insulin for your personal use from a
foreign country, if you follow certain FDA
and United States Department of Agriculture
(USDA) requirements. The FDA allows the
importation of some unapproved drugs into
the U.S. under certain conditions, such as
if the product is medically necessary and
not available in the U.S. If a person with
diabetes can not be treated with either
human or pork insulin, the FDA and USDA
often permits them to import beef insulin
into the U.S. for personal use. For more
information about the importation of beef
insulin, please feel free to contact the
USDA at: 1-301-734-3277 or visit their
website at www.usda.gov.
Again, thank you for contacting me, and
please keep in touch.
ROBERT G. TORRICELLI
United States Senator