Carbenoxolone, cimetidine, and chenodeoxycholic acid are unavailable in the United States. Other pharmacologic agents such as lactulose and pentagastrin have recently become available, but only many years after they were demonstrated to be both safe and effective. The radioimmune assay for the detection of hepatitis B surface antigen was withheld from commercial blood bank use by licensing agencies for almost two years, while greater specificity testing could be performed. This was done despite easily documented observations that the test was far more reliable and sensitive than the counterelectrophoresis tests that were being used by blood banks in 1971 and 1972. The banning by the Food and Drug Administration of commercial distribution of serologic reagents for the detection of alpha-fetoprotein until the "safety and efficacy" of such reagents could be demonstrated, was the subject of a scathing editorial by Milunsky and Alpert (N Engl J Med 295:168, 1976). It has been alleged that if penicillin and digitalis were required to undergo the same scrutiny that new drugs incur, they would never be licensed. The Food and Drug Administration is mandated by law to assure that drugs are both safe and effective; however, have the bureaucracy and regulations that have been promulgated to protect the public gone too far? From 1974 through 1976 Dr. William H. Bachrach served as leader of the Gastrointestinal Drug Group in the Division of Cardio-Renal Drug Products, Bureau of Drugs, Food and Drug Administration. He is presently Professor of Medicine and Chief of the Gastroenterology Section at the Baylor College of Medicine. Dr. Bachrach defends the regulatory process and summarizes the current status of the evaluation process with respect to several drugs of interest to the gastroenterologist. Dr. Alastair M. Connell is Associate Dean, Mark Brown Professor of Medicine, and Director of the Division of Digestive Diseases at the University of Cincinnati Medical Center. He attacks excessive regulation of drugs and diagnostic agents as detrimental. ALLEN L. GINSBERG, MD