Malloy, Mrs. John, San Diego, Calif., accompanied by Mrs. Albert Green, Glencove, Long Is., and Mrs. Janice Luder, Los Angeles, Calif., a panel__ Greenwald, Peter, M.D., director, Cancer Control Bureau of New York State Department of Health, clinical assistant professor of medicine at the Albany Medical School, and assistant attending physician at the Albany Medical Center Hospital, accompanied by Robert H. Pantell, M.D., consulting pediatrician and clinical scholar at the Stanford Uni- versity School of Medicine, and Ms. Belita H. Cowan, college instructor of health care in Ann Arbor, Mich., a panel_ Seife, Dr. Marvin, Director of the Generic Drug Division, Bureau of Drugs, Food and Drug Administration, accompanied by Dr. Vincent Karusaitis, obstetrician and gynecologist, medical officer in the Generic Drug Divi- sion, Food and Drug Administration__. Furman Robert H., M.D., vice president, Lilly Research Laboratories, Eli Lilly, Inc., accompanied by Robert L. Pillarella, president, Tablicaps, Rauscher, Frank, Ph. D., Director, National Cancer Institute, National In- stitutes of Health, accompanied by Alexander M. Schmidt, M.D., Com- missioner, Food and Drug Administration; J. Richard Crout, M.D., Di- rector, Bureau of Drugs; Peter Barton Hutt, General Counsel; and Robert C. Wetherell, Jr., Director, Office of Legislative Services_. Furman, Robert H., M.D., vice president, Lilly Research Laboratories, Eli Lilly, Inc., accompanied by Robert L. Pillarella, president, Tablicaps, Greenwald, Peter, M.D., director, Cancer Control Bureau of New York State Department of Health, clinical assistant professor of medicine at the Albany Medical School, and assistant attending physician at the Al- bany Medical Center Hospital, accompanied by Robert H. Pantell, M.D., consulting pediatrician and clinical scholar at the Stanford University School of Medicine, and Ms. Belita H. Cowan, college instructor of health care in Ann Arbor, Mich., a panel---. Malloy, Mrs. John, San Diego, Calif., accompanied by Mrs. Albert Green, Glencove, Long Is., and Mrs. Janice Luder, Los Angeles, Calif., a panel__ Rauscher, Frank, Ph. D., Director, National Cancer Institute, National In- stitutes of Health, accompanied by Alexander M. Schmidt, M.D., Com- missioner, Food and Drug Administration; J. Richard Crout, M.D., Di- rector, Bureau of Drugs; Peter Barton Hutt, General Counsel; and Robert C. Wetherell, Jr., Director, Office of Legislative Services__ Seife, Dr. Marvin, Director of the Generic Drug Division, Bureau of Schmidt, Alexander M., M.D., Commissioner, Food and Drug Administra- Greenwald, Peter, M.D., director, Cancer Control Bureau of New York State Department of Health, clinical assistant professor of medicine at the Albany Medical School, and assistant attending physician at the Al- bany Medical Center Hospital, prepared statement (with attachments) – Pantell, Robert H., M.D., consulting pediatrician and clinical scholar, Stan- ford University School of Medicine, prepared statement__ Cowan, Belita H., college instructor of health care in Ann Arbor, Mich., Seife, Marvin, M.D., Director of the Generic Drug Division, Bureau of Rauscher, Frank J., Jr., Ph. D., director, National Cancer Program, Na- tional Cancer Institute, National Institutes of Health, prepared state- Vaginal Cancer After Maternal Treatment With Synthetic Estrogens, by Peter Greenwald, M.D., Joseph J. Barlow, M.D., Philip C. Nasca, M.S., and William S. Burnett, M.D., from the New England Journal of Medi- cine, vol. 285, August 12, 1971_ Diethylstilbestrol Contraindicated in Pregnancy, FDA Drug Bulletin, Adenocarcinoma of the Vagina, Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women, by Arthur L. Herbst, M.D., Howard Ulfelder, M.D. and David C. Poskanzer, M.D., from the New England Journal of Medicine, April 22, 1971_ Postcoital Diethylstilbestrol, FDA Drug Bulletin, May 1973-. Prenatal Exposure to Stilbestrol, a prospective comparison of exposed female offspring with unexposed controls, by Arthur L. Jerbst, M.D., David C. Poskanzer, M.D., Stanley J. Robboy, M.D., Lawrence Fried- lander, M.D., and Robert E. Scully, M.D., from the New England Journal of Medicine, vol. 292, No. 7, February 13, 1975__ Postcoital Contraception With Diethylstilbestrol, by Lucile Kirtland Kuchera, M.D., from Jama, vol. 218, No. 4, October 25, 1971_. Diethylstilbestrol as a "Morning After" Pill, paper from the University of Certain Estrogens for Oral or Parenteral Use, from the Federal Register, vol. 38, No. 186, September 26, 1973_-_. DES Label and Packaging Changes When Used as Emergency "Morning After" Contraceptive, news release of FDA, September 21, 1973_. New Drugs-Diethylstilbestrol as Postcoital Oral Contraceptive; Patient Labeling, from the Federal Register, vol. 40, No. 25, February 5, 1975__ Morning After Pill: Diethylstilbestrol (DES), FDA talk paper, February 5, Furman, Robert H., M.D., vice president, Lilly Research Laboratories, Page 65 26 Tablicaps, Inc., Robert L. Pillarella, president, prepared statement (with 32 132 REGULATION OF DIETHYLSTILBESTROL (DES), 1975 THURSDAY, FEBRUARY 27, 1975 U.S. SENATE, SUBCOMMITTEE ON HEALTH OF THE PROCEDURE OF THE COMMITTEE ON THE JUDICIARY, Washington, D.C. The subcommittee met, pursuant to notice, at 9:34 a.m., in room 4232, Dirksen Senate Office Building, Senator Edward M. Kennedy (chairman of the Subcommittee on Health), presiding. Present: Senators Kennedy and Schweiker. Committee staff present: LeRoy G. Goldman and Walter Sheridan, professional staff members; and Jay B. Cutler, minority counsel. Senator KENNEDY. The subcommittees will come to order. DES is a drug out of control. It is known to cause cancer in the daughters of some mothers who take it during pregnancy. It is in widespread use in the United States as a morning after contraceptive and has been for many years. The knowledge of this wide and inappropriate usage is, in part, responsible for FDA's recent decision to approve it as a morning after pill in emergency situations. In previous testimony before the Health Subcommittee, FDA has defined such emergencies to be rape, incest, or a similar tragedy. All experts agree that, because it does cause human cancer, DES must be used with great caution and only in emergency situations. Most experts also agree that continued widespread misuse would present a major health hazard. These statistics which exist must make one skeptical that the drug will be used as advised by the FDA. It is ironic and disheartening that the FDA, through a major bureaucratic error, has contributed to the national confusion about DES. In May 1973, the FDA sent out its drug bulletin to physicians, informing them that the agency had approved DES as a morning after pill for emergency situations. The bulletin was wrong. The drug was not approved until this month-almost 2 years later-but the error was never corrected. In effect then, in the real world, doctors have been operating since 1973 under the assumption that the drug has been approved for emergencies. Thus, for example, the University of Michigan has been informing its coeds that the drug is FDA approved since that time. At that university, the definition of emergency has gone far beyond rape and incest. (1) The fact that the Commissioner acknowledges widespread use of the drug as a morning after pill in his statement this morning must be interpreted in light of the fact that doctors were explicity, although incorrectly, told by FDA that its use was for emergencies only. Why, then, should it be assumed that appropriate use will result from the now official approval of the drug? My concern is for those times that DES does not work and female children are born. How many times will that happen if the drug is widely misused? How many times will the patient be lost to followup or take the drug when already pregnant? How sure are we that there will be no risk to the mother at all? The tragic consequences of misuse of DES will be made dramatically clear at this hearing. Who should be responsible if misuse of the drug continues and more American daughters fall victim to a deadly cancer? Is it the FDA's responsibility to assure appropriate use? Is it the drug industry's? Is it the medical profession's? Will any group assume the responsibility? DES is also still being used as a cattle feed additive. The FDA has been trying, administratively, to remove it from the market for 2 years. Because of procedural difficulties, the District of Columbia Court of Appeals overturned their ban on DES in January 1974. Now, we are back where we started. DES is once again appearing on the American dinner table. In the week of January 31, 1975, residues were reported to be as high as 4.1 parts per billion. The Department of Agriculture has reinstituted its certification program. The Director of the National Cancer Institute, who we will hear from this morning, is on record supporting the removal of DES from cattle feed. So is the Director of the Cancer Control Bureau of New York State, who is also with us this morning. So is the U.S. Senate, which passed a ban on DES in 1972. So is FDA, which moved, although inadequately, to remove it from the market. Over 20 countries prohibit its use. Two countries have banned the importation of American DES-fed meat. Yet, when this Nation sits down to eat around the dinner table tonight, if they have meat, they may still be ingesting DES. What will it take to get it out of meat? If we do not get assurances today of prompt action by FDA on this matter, I will reintroduce legislation to ban the use of DES in cattle feed, and hopefully will be joined by many of my colleagues in the U.S. Senate. Given the substantive relevance of the health subcommittee's past hearings on the public health problems associated with the use of DES in animals, I intend to incorporate in this hearing record pertinent portions of the 1972 hearings in the appendix. [The bill subsequently introduced follows:] 91T CONGRESS 1ST SESSION S. 963 IN THE SENATE OF THE UNITED STATES MARCII 5, 1975 Mr. KENNEDY (for himself and Mr. SCHWEIKER) introduced the following bill; which was read twice and referred to the Committee on Labor and Public Welfare A BILL To amend the Federal Food, Drug, and Cosmetic Act to prohibit the administration of the drug diethylstilbestrol (DES) to any animal intended for use as food, and for other purposes. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That section 301 of the Federal Food, Drug, and Cosmetic 4 Act is amended by adding at the end thereof the following 5 new subsections: 6 "(q) The administering of the drug diethylstilbestrol 7 (DES) to any animal intended for use as food or any animal 8 the product of which is intended for use as food. II |