Letters, statements, etc.-Continued Fountain, Hon. L. H., a Representative in Congress from the State of Excerpt from new drug applications for Flexilon... Excerpt of letter from FDA, to McNeil Laboratories, April 6, Excerpt of letter from George P. Larrick, Commissioner, Food August 19, 1964 Gray, W. Donald, senior investigator, Intergovernmental Relations Excerpt from letter submitted with original new drug application Excerpt from statement re description of the animal data Excerpt of memorandum from Dr. Bert J. Vos, Director, Division Kohlstaedt, Kenneth G., M.D., executive director, Medical Research, Chart-Birth of a new drug for FDA....... Developing and testing of new drugs by the pharmaceutical Excerpt from FDA form for investigational drugs. Page 605 736 462 791 645 674 717 731 596 754 624 636 Faces page 518 533 562 544 558 525 Letter from George P. Larrick, Commissioner, Food and Drugs, "The Early Life History of a New Drug," by S. O. Waife, M.D. Answers to questions submitted for the record by the subcommittee. 653 592 575 Excerpt from supplemental new drug application to FDA for 574 History of a New Drug Application. 632 Letter from John L. Harvey, Deputy Commissioner, Food and 615 Numbers of medical officers and veterinarians requested in the 618 McNinch, Dr. Joseph H., Chief Medical Director, Department of Directive, part of Veterans' Administration Services Manual, 363 372 369 Memorandum No. 10-63-29-Central Office Procedure on Ad- 368 Samples of adverse drug reaction reports: Veterans' Administration Hospital, Bronx, N.Y., March 31, 1964. 376, 379, 380 Veterans' Administration Center, Whipple, Ariz., March 31, Veterans' Administration Hospital, Memphis, Tenn., March 377 378 Letters, statements, etc.--Continued Mider, Dr. G. Burroughs, Director, Laboratories and Clinics, National Boards of scientific counselors of the National Institutes of Excerpt from the Federal Food, Drug, and Cosmetic Act, as Part 6-Inventions and patents (general). Part 8-Inventions resulting from research grants, fellow- Part 6-Patents and inventions, Manual: General Admin- Part 8-Inventions resulting from research grants, fellow- Patent policy applicable to cancer chemotherapy industrial Moss, Hon. John E., a Representative in Congress from the State of Rankin, Winton B., Assistant Commissioner for Planning, Food and Excerpt from original Orabilex labeling... Summary of reports of kidney damage associated with Orabilex.. Page 444 450 448 472 473 475 478 477 477 480 746 726 689 791 646 434 Timm, Dr. Oreon K., Assistant Chief Medical Director for Professional Services, Veterans' Administration: Information re reporting of adverse drug reactions... 373 387 Trygstad, Vernon, Director of Pharmacy Services, Veterans' Admin- 389 428 Vos, Bert J., M.D., Director, Division of Toxicology Evaluation, Excerpt from evaluation by Dr. Geoffrey Woodard of animal 592 745 Excerpt from summarization of Dr. Deichmann's evaluation of 759 Letters, statements, etc.-Continued Zbinden, Gerhard, M.D., vice president, Research Division, Hoffmann- Conclusions reached in 1963 re need for more toxicological studies. Letter from Thomas D. Finney, Jr., Clifford & Miller, to Donald Exhibit 1-Memorandum from Robert L. McNeil, Jr., vice president, McNeil Laboratories, Inc., to Food and Drug Administration, Novem- ber 14, 1955, and excerpt from Flexin new drug application.. Exhibit 2-Communications from Dr. B. Alpers, Jefferson Medical College, to Dr. James M. Shaffer, McNeil Laboratories, re case of hepatitis in Exhibit 4-Page on adverse reactions, from supplemental new drug appli- cation for Flexin, June 11, 1958.- Exhibit 5-Excerpt re adverse reactions to Flexin from proposed brochure submitted with supplemental new drug application of June 11, 1958--- Exhibit 6-Intra-agency memorandum re supplemental new drug appli- cation for Flexin, July 23, 1958.. Exhibit 7-Excerpt from supplemental new drug application for Flexilon. Exhibit 8-Article describing fatal liver damage in two patients receiving Exhibit 11-Memorandum from Robert L. McNeil, Jr., chairman of the board, McNeil Laboratories, Inc., to Food and Drug Administration, March 21, 1960, and final draft of Triurate index card__ Exhibit 12-Draft of proposed warning letter to physicians to accompany mailing of revised labeling for Flexin, Flexilon, Flexilon-HC, and Exhibit 13-Revised labeling proposed for Flexin... Exhibit 14-Suspension order for Flexin new drug application.... Exhibit 15-Excerpts from Paraflex new drug application. - Exhibit 16-Letter from Robert J. Robinson, M.D., medical officer, New Drug Surveillance Branch, Division of New Drugs, Bureau of Medicine, to McNeil Laboratories, Inc., re effectiveness of Paraflex, August 6, 1964_ Exhibit 17-Descriptions of Paraflex products from 1962 physician's desk Exhibit 20-Letter from A. J. Donnelly, Institute for Cancer Research, Philadelphia, Pa., to Charles F. Kade, Jr., M.D., McNeil Laboratories, Exhibit 21A-Excerpt from new drug application for tablets Flexilon- Exhibit 21B-Excerpt from new drug application for tablets Flexilon-HC.. Exhibit 22-Intra-agency memorandum re suspected case of liver damage Exhibit 23-Letter from Barbara Moulton, M.D., medical officer, New Drug Branch, Division of Medicine, to McNeil Laboratories, Inc., making effective the new drug application for Flexin......--- Exhibit 24-Intraagency memorandums re Triurate new drug application and letter making the application effective_-_. Exhibit 25-Report of Special Committee advisory to the Secretary of Health, Education, and Welfare to review the policies, procedures, and decisions of the Division of Antibiotics and the New Drug Branch of the Food and Drug Administration. Exhibit 26-Correspondence concerning reports of bone marrow depression Exhibit 27-Memorandum from James M. Shaffer, M.D., director, Exhibit 28B-Hepatotoxicity during Zoxazolamine (Flexin) therapy: Exhibit 31-Letter from Henry S. McNeil, president, McNeil Laboratories, Exhibit 34-Original physician's brochure for Orabilex. Exhibit 35-Letter from Sydney F. Thomas, M.D., associate professor of Exhibit 36-Letter from Sydney F. Thomas, M.D., associate professor of Exhibit 37-Post card questionnaire from Sydney F. Thomas, M.D., asso- Page 626 637 650 654 656 657 665 671 672 673 673 674 679 686 686 687 689 692 693 Exhibit 39-Proposed labeling changes for Orabilex... 696 698 Exhibit 42-Revised labeling, Orabilex_ 699 Exhibit 43-Telegram from M. L. Weinstein, M.D., and N. E. Roberti, M.D., Martin Luther Hospital, Anaheim, Calif., to Hon. Anthony Celebrezze, April 12, 1963.... 709 Exhibit 44-Letter from Sydney F. Thomas, M.D., to William B. Seaman, 710 Exhibit 45-Letter from E. Fougera & Co., Inc., to doctors re Orabilex recall, January 27, 1964.. 712 Exhibit 46-Letter from E. Fougera & Co., Inc., to the drug buyer re 712 Exhibit 47-Letter from E. Fougera & Co., Inc., to the accessories buyer re 713 Exhibit 48-Letter from E. Fougera & Co., Inc., to the pharmacist re 713 Exhibit 49A-Telegram from E. Fougera & Co., Inc., to drug wholesalers re Orabilex recall, February 14, 1964.. 714 Exhibit 49B-Telegram from E. Fougera & Co., Inc., to X-ray suppliers re Orabilex recall, February 17, 1964- Exhibit 50-Letter from E. Fougera & Co., Inc., to doctors re Orabilex Exhibit 51-Withdrawal of approval in the matter of Orabilex capsules_- Exhibit 53-Memorandum from E. C. Hagan, Division of Pharmacology, Exhibit 54-Letter from Clarke Davison, Ph. D., associate professor of pharmacology, George Washington University, to Hon. L. H. Fountain, March 21, 1964__ Exhibit 55-Intra-agency memorandum re Orabilex toxicity, November 16, 1962_ Page 714 714 714 715 717 717 735 Exhibit 56-Intra-agency memorandum re additional animal data on 737 Exhibit 57-Evaluation of animal studies with bunamiodyl sodium (BUN) (Orabilex) by consultants to E. Fougera & Co...-- 741 Exhibit 58-Letter and report from Leberco Laboratories, Roselle Park, Exhibit 59-Clinical evaluation reporting form for Orabilex.. Exhibit 61-Excerpts from supplemental new drug application for Ora- Exhibit 63-Intra-agency memorandum from Margaret A. Milliken, M.D., Exhibit 64-List of adverse reactions to Orabilex reported to FDA through Exhibit 66-Letter from W. B. Rankin, Assistant Commissioner, Food 750 760 767 776 786 794 794 796 797 805 |