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. Sincerely, ROBERT G. TORRICELLI United States Senator RGT:akp