HEARINGS BEFORE A 4-APR-9 SUBCOMMITTEE OF THE COMMITTEE ON 1970 GOVERNMENT OPERATIONS. T HOUSE OF REPRESENTATIVES NINETY-FIRST CONGRESS FIRST SESSION APRIL 17, 18, AND 22, 1969 Printed for the use of the Committee on Government Operations 72-606578 37-327 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1970 Statement of Dr. Herbert L. Ley, Jr., Commissioner of Food and Drugs, Consumer Protection and Environmental Health Service, Public Health Service, Department of Health, Education, and Welfare; accompanied by William W. Goodrich, Assistant General Counsel, HEW; J. Kenneth Kirk, Associate Commissioner for Compliance; B. Harvey Minchew, M.D., Acting Director, Bureau of Medicine; John Jennings, M.D., Acting Deputy Director, Bureau of Medicine; Jean Lockhart, M.D.; Letters, statements, etc., submitted for the record by- Fountain, Hon. L. H., a Representative in Congress from the State of North Carolina, and chairman, Intergovernmental Relations Joint letter along with Congresswoman Florence P. Dwyer to Dr. Herbert L. Ley, Jr., Commissioner of Food and Drugs, Consumer Protection and Environmental Health Services, Public Health Service, Department of Health, Education, and Welfare re problems concerning FDA's policies and actions with respect to certain chloramphenicol products dated April Letter from Dr. Herbert L. Ley, Jr., in answer to joint letter of Sundry communications concerning complaints by Rachelle Laboratories, Inc., re Parke, Davis & Co., use of chloram- phenicol sodium succinate as opposed to their limited use of Sundry communications in support of the effectiveness in the use of chloramphenicol and/or chloramphenicol sodium suc- Gray, W. Donald, senior investigator, Intergovernmental Relations Report of Panel on Anti-Infective Drugs (III) re effectiveness or 114 Ley, Dr. Herbert L. Jr., Commissioner of Food and Drugs, Consumer Protection and Environmental Health Service, Public Health Service, Department of Health, Education, and Welfare: Communications re patient consent for volunteer studies con- Letters, statements, etc.-Continued High-ranking personnel who have left FDA for nonregulated Page High-ranking personnel who have left FDA for regulated in- Initial batches of chloramphenicol capsules certified, table__ February 21, 1968.. May 2, 1969 May 12, 1969. July 22, 1968. April 16, 1970.. 26 17 171 96 109 109 112 130 Rachelle Laboratories, Inc., original labeling of March 23, 1967, Statement... Sundry correspondence re resignation of Dr. Robert M. Hodges 59 6 31 DRUG EFFICACY (Part 1) THURSDAY, APRIL 17, 1969 HOUSE OF REPRESENTATIVES, INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, D.C. The subcommittee met at 10 a.m. in room 2203, Rayburn House Office Building, the Honorable L. H. Fountain (chairman of the subcommittee) presiding. Present Representatives L. H. Fountain, Benjamin S. Rosenthal, Clarence J. Brown, and Guy Vander Jagt. Professional staff present: Delphis Č. Goldberg, W. Donald Gray, and Robert S. McCleery, Intergovernmental Relations Subcommittee, and William P. Russell, assistant minority counsel, Committee on Government Operations. Mr. FOUNTAIN. Let the subcommittee come to order and the record. show that a quorum of the members are present. I would like for the record to show that Mrs. Dwyer, the ranking minority member of our subcommittee, has asked me to express her deep personal interest in this hearing, and in the unfortunate situation with which it is concerned. Mrs. Dwyer regrets very much her inability to be with the subcommittee today, but she has asked me to assure all concerned that she intends to study the hearing record and join in whatever subsequent action may be indicated. This morning the subcommittee resumes its hearings on the drug safety activities of the U.S. Food and Drug Administration. These hearings have extended over a considerable period of time and have covered many aspects of the agency's activities in the drug field. However, one area which the subcommittee has not explored in depth is that pertaining to the agency's responsibility for assuring that drugs on the market are effective as well as safe for their intended use. This responsibility was given to the Food and Drug Administration by the Drug Amendments Act of 1962 and applies both to completely new drugs and to drugs which were approved for marketing prior to 1962 on the basis of safety alone. This morning we will examine FDA's handling of the antibiotic chloramphenicol. Chloramphenicol is a potent antibiotic with a wide range of activity which has been on the market for many years. However, because chloramphenicol is also known to cause serious and potential fatally blood disorders, its labeling has been progressively restricted so that its use is presently limited to serious and life threatening conditions for which there is no effective alternative treat ment. (1) |