Public health issues concerning the use of BST

Abstract

BST is currently undergoing clinical testing and is considered an investigational new animal drug subject to all of the requirements and oversight previously discussed. At this stage of the approval process, information about a drug is proprietary to the companies submitting the data to the FDA Because of the broad interest in BST, however, the companies have disclosed more information than is normally available at this early phase of the approval process.

The FDA's mission remains the same: to ensure that the nation's pharmaceutical and biological products are safe and effective and that the food supply is safe and nutritious. The law requires that our review of any new drug product, including drugs made through recombinant DNA technology such as BST, focus on whether that product is safe and effective for its intended use. The Center for Veterinary Medicine's scientists work diligently to carry out that responsibility. It is my belief that they do it as well as it can be done.

Presented at the 1989 Annual Fall Conference for Veterinarians, University of Minnesota, St. Paul, MN, October 26, 1989.