Drug Efficacy Study: Final Report to the Commissioner of Food and Drugs - Food and Drug Administration (1969)

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~RUG EFFICACY STUDY Final Report to the Commissioner of Food and Drugs Food and Drug Administration from the Division of Medical Sciences ,K. ,,National Research Council National Academy of Sciences Washington, D. C. OCT 2 9 1S81 1969 i LIBRARY 

., .";- . This study was prepared under FDA contract 66-197 (neg) SPONSORED BY THE PUBLIC HEALTH SERVICE CONSUMER PROTECTION AND ENVIROMENTAL HEALTH SERVICE FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE RM300 .077 I 969 c. 1 Drug efficacy study : Final reoprt to the Commissioner ... Order from National Technical Information Service, Springfield, Va. 22161 Order No. ft> d.3/-lo4~ i1 

PREFACE This report of the activities of the Drug Efficacy Study is sub- mitted to the Commissioner of Food and Drugs at the time of the Study's completion. The narrative section of the report describes the administrative structure of the Study and its scope, progress, and completion, and identifies the major problems encountered along the way. The appendixes comprise a series of general statements on the prin- ciples of usage of various categories of drugs that were prepared by a number of the panels to supplement their recommendations on individual drugs. The report and its appendixes constitute the permanent record of the work of the Drug Efficacy Study. Additionally, it is hoped that many of the general statements, as well as the substance of the reports on individual drugs, will find their way into the mainstream of medical literature. iii 

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CONTENTS I. INTRODUCTION. • • • • • . • . . • • • • • • • • • • • 1 II. DESIGN AND CONDUCT OF THE STUDY • • • • • • • • • • • • • • 2 III. THE INFORMATIONAL BASE OF THE STUDY • • • • • • • • 4 IV. SCOPE OF THE STUDY • • • • . . • . • • • • • 5 v. PROGRESS OF THE STUDY • • • • • • 5 VI. THE MAJOR PROBLEMS ENCOUNTERED. • 6 VII. LOOKING TO THE FUTURE • 13 VIII. ACKNOWLEDGMENTS • • • • • • • • • 15 APPENDIXES: A. APPENDIXES NOTED IN THE REPORT OF THE DRUG EFFICACY STUDY 1. Members of the Executive Committee of the Policy Advisory Committee, Drug Efficacy Study • • • • • 21 2. Chairmen and Members of Panels, Drug Efficacy Study. • • . . . . . . . . . . . . . . . . . . . 23 3. Guidelines of the Drug Efficacy Study • • • • • 39 a. Members of the Policy Advisory Committee, Drug Efficacy Study. • • • • • • • • • • • 46 b. Federal Register Announcement of 9 July 1966 • 49 c. Form A and Form B, Drug Efficacy Study • • • • • • • • 51 4. Members of the Professional Staff, Drug Efficacy Study 55 5. Replies of Members of Panels to Letter of 24 January .l969. 57 I. Retrospective 1. The Quality of Evidence of Effectiveness • • 61 2. The Quality of Labeling Materials • • • • • 65 3. Reflections on Fixed Combinations of Drugs 72 4. Reflections on Therapeutic Equivalence •• 77 II. Prospective 1. The Need for Nongovernment Participation in Drug Evaluation. • • • . • • • • • • • • • • • • • 82 2. The Need for Continuing Review of the Drug Market • • • . • • . . • • . . • • • • • . 86 3. Reflections on Testing Procedures • • • • • 92 4. Reflections on the Need for a Compendium 97 5. Training Needs • . • . . . . . • • • 101 B. GENERAL STATEMENTS OF PANELS ON USES OF SELECTED CATEGORIES OF DRUGS 1. Panel on Drugs for Relief of Pain Statement Concerning the Package Inserts Used for Drugs for Relief of Pain . • • . . • • • 105 2. Panel on Drugs Used in Anesthesiology a. Statement on the Use of Analeptic Drugs. 109 b. Statement on the Use of Central Muscle Relaxants • 113 v 

c. Statement on Criteria for Evaluation of Drug-Induced Respiratory Changes • • • • • • • • • • • 114 d. Statement on Criteria for Evaluating the Efficacy of Antiemetic Drugs • • • • • • • 116 e. Statement on the Use of Local Anesthetics • • • • • • • 118 f. Statement on the Use of Neuromuscular Blocking Agents. . • • • ••••••• 120 g. Statement on the Use of Pre-anesthetic Drugs • • 121 h. Statement on Treatment of Postoperative Nausea and Vomiting. • • • • • • • • • • • • 122 3. Panels on Anti-Infective Drugs a. White Paper on Fixed Combinations of Anti- microbial Agents • . • • • • • • • • • • • 123 b. Recommendations Concerning the Package Inserts for Streptomycin and Dihydrostreptomycin • • • • 140 c. Recommendations Concerning the Package Inserts for the Sulfonamides • • • • • • • • • • • • ,• • 149 d. Statement Concerning the Package Insert Infor- mation for Antituberculosis Drugs • • • • • • • • • • . 153 e. Statement on the Use of Corticotrophin (ACTH) and Corticosteroids in Tuberculosis and Infectious Diseases • . • • • • • • • • • • • • • • • • 155 4. Panels on Cardiovascular Drugs a. Statement on Criteria for Evaluation of Long- Acting Coronary Vasodilators in Treatment of Angina Pectoris • • • • • • • • • • • • • • • • • 161 b. Statement on Use of Corticosteroids in Rheu- matic Fever and Shock. • • • • • • • • • • • • 165 c. Recommended Package Insert for the Digitalis Preparations • . . • • • • • • • • • • • • • • • • • • 172 d. Recommended Package Insert for Reserpine Prep- arations Used in the Treatment of Hypertension • 176 e. Statement on Use of Sympathomimetic Amines in Treatment of Hypotension and Shock • • • • • • 181 f: Statement on Use of the Thiazide Diuretics • 182 g. Statement on Use of Xanthines in Congestive Heart Failure and Angina Pectoris • • • • • • • • • 183 5. Panel on Drugs Used in Dentistry a. Statement on the Use of Corticosteroids •• 185 b. Statement on the Use of Mouthwashes • • • • 187 6. Panels on Drugs Used in Dermatology a. Statement on the Use of Undecylenic Acid in the Treatment of Dermatophytoses • • • • 189 b. Statement on the Use of Topical Anesthetics. ..:92 7. Panels on Drugs Used in Gastroenterology Statement on the Use of Antiemetic Drugs • • 195 8. Panel on Drugs Used in Hematologic Disorders and Panel on Antineoplastic Drugs a. Statement on the Use of Adrenocortical Steroids in Hematologic Disorders • • • • • • • • • • • • . • • , 197 vi 

b. Statement on the Use of Adrenocortical Steroids in Neoplasia . . • • • • • • • • • • • • • • • 200 c. Statement on the Use of Androgens in Neoplasia • 204 d. Statement on the Use of Antihistamines in Transfusion Reactions. . • • . • • . • • • • • • 206 e. Statement on the Use of Estrogens in Neoplasia 208 f. Statement on the Use of Vitamin K in Hypoprothrombinemia. • • • • . • • • . • • • • . • • • 211 9. Panel on Drugs Used in Endocrine Disturbances and Panel on Drugs Used in Metabolic Disorders a. Statement on the Use of Multiple-Vitamin Preparations . . • • . • • • • • 213 b. Statement on the Use of Propylthiouracil • • • • • 214 c. Statement on the Use of Single-Vitamin Preparations • • . • . • • • • • • • • 217 10. Panel on Drugs Used in Ophthalmology Statement on Ocular Changes Secondary to the Use of Systemic Steroids • • • • • • . • • • 219 11. Panel on Drugs Used in Rheumatic Diseases a. Statement on the Use of Combination Drugs. 223 b. Statement on the Use of Corticosteroids and Corticotrophin&. • . . • • • • • • • • • 224 c. Statement on the Use of Cortisol and Cortisone • 231 d. Statement Concerning the Package Inserts in Drugs Used in Rheumatic Diseases • • • • • • • • • • • 232 12. Panel on Drugs Used in Respiratory Disturbances a. Statement on Cough Therapy for Use in Package Inserts of Prescription Drugs. • • • • • • • 233 b. Statement on Cough Therapy for Use in Package Inserts of Over-the-Counter Drugs. • • • • • 234 13. Panel on Drugs Used in Surgery Statement on the Use of Corticosteroids in Shock • 235 C. WHITE PAPER ON THE THERAPEUTIC EQUIVALENCE OF CHEMICALLY EQUIVALENT DRUGS • • • . • • • • • • • • • • • • • • • • 241 vii