DIETHYLSTILBESTROL (DES) TUESDAY, DECEMBER 16, 1975 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, D.C. The subcommittee met, pursuant to notice, at 1:30 p.m., in room 2322, Rayburn House Office Building, Hon. Paul G. Rogers, chairman, presiding. Mr. ROGERS. The subcommittee will come to order, please. This afternoon the subcommittee begins its consideration of legislation which would affect the use of a controversial estrogen, diethylstilbestrol-DES-which is a known carcinogen. Diethylstilbestrol, or DES as it is commonly known, is currently in widespread use as a growth promotant for beef cattle. DES, whether fed to or implanted in beef cattle leads to a more rapid production of lean meat and improves the efficiency of conversion of feed into beef. The known carcinogenic nature of DES and the likelihood that residues of the substance are finding their way into the human food chain, however, have led to public demands that DES be banned as a cancercausing food additive under the Delaney clause of the Food, Drug, and Cosmetic Act. In 1973 FDA banned DES for use in beef and sheep production, but the ban was nullified by the U.S. Court of Appeals for the District of Columbia circuit, primarily on the basis that FDA had conducted no hearings prior to its action. This afternoon's hearing will focus on the therapeutic uses of DES in humans, principally in women. During the 1940's and early 1950's DES was frequently prescribed in obstetrical practice for the treatment of habitual or threatened miscarriage. In 1971 an association was reported and confirmed between the maternal ingestion of DES during pregnancy and the occurrence of vaginal cancer in the female offspring. A new study has been published recently which broadens the association to include male offspring. DES is also used to suppress lactation and to treat menopausal syndrome, and, in recent years, DES has seen an increasing use as a postcoital contraceptive, a morningafter pill. This subcommittee has always been reluctant to usurp the legitimate role of the regulatory agency in making determinations based on sound, scientific data. It is, however, this subcommittee's responsibility to insure that the Food and Drug Administration's regulatory policies adequately protect the public health. We have scheduled witnesses today who will speak to both sides of this controversial issue and expect to develop a balanced hearing record so that any subcommittee decision to legislate with respect to DES will be based on complete information. Without objection, the text of title I of S. 963 as it passed the Senate on September 9, 1975, will be placed in the record at this point. [Text of title I of S. 963 follows:] (1) To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the introduction or delivery for introduction into interstate commerce of the drug diethylstilbestrol (DES) for purposes of administering the drug 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, TITLE I-CANCER PREVENTION 3 4 SEC. 101. Section 301 of the Food, Drug, and Cos5 metic Act is amended by adding at the end thereof the fol6 lowing new subsection: 7 "(q) The administering of the drug diethylstilbestrol 8 (DES) to any animal intended for use as food or any animal I 2 1 the product of which is intended for use as food until the 2 Secretary makes a determination, based on scientific evi3 dence and acting through the National Cancer Institute of 4 the National Institutes of Health, that the drug DES is 5 safe and presents no significant health hazard and does not 6 contribute unreasonably to man's carcinogenic burden. For 7 purposes of this subsection, the Secretary of Health, Educa8 tion, and Welfare is directed to accumulate and analyze all 9 data related to the public health aspects of the use of diethyl10 stilbestrol (DES) as a growth promotant in animals intended 11 for use as food, and to report to the Congress the results 12 of such accumulation and analysis, together with his recom13 mendations as to the appropriate course of action to be taken 14 with regard to such use of DES. Such data shall be made 15 available to the Secretary of Agriculture, who shall make an independent and concurrent report to the Congress with 17 the Secretary of Health, Education, and Welfare as to the 16 18 appropriate course of action to be taken with regard to such 19 use of DES. Such report shall be submitted within four 20 months after the final report on the DES portion of the 21 Estrogen Project of the National Center for Toxicological 22 Research (NCTR) Division of the Food and Drug Adminis23 tration, and shall include the results of all studies on DES 24 completed as of the date of completion of the NCTR studies.". 1 3 SEC. 102. Section 502 of the Food, Drug, and Cosmetic 2 Act is amended by adding at the end thereof the following "(q) (1) If it is, or purports to be, or is represented as a drug composed wholly or partly of diethylstilbestrol 4 5 6 (DES), unless "(2) THIS DRUG MAY NOT BE USED AS A CONTRACEPTIVE AFTER SEXUAL 66 9 10 11 12 13 14 15 16 17 18 19 20 21 AND 2235 (3) THIS DRUG MAY NOT BE TAKEN UNLESS A PATIENT OR PATIENT'S LEGAL GUARDIAN HAS GIVEN HIS WRITTEN CONSENT AFTER FULL VERBAL DISCLOSURE BY THE ATTENDING PHYSICIAN OF THE RISKS, BENEFITS, ALTERNATIVE METHODS TREATMENT; and OF "(B) each and every capsule or tablet is pre packaged, by the drug producer, in units which contain 4 the appropriate number of capsules or tablets for the desired course of treatment and the statements required by subsection (q) (1) (A) of this section are conspicuously placed on the label next to the capsules or tablets so as to permit the patient an opportunity to read the statements during the entire prescription period. The letters contained in the statements required by subsection (q) (1) (A) of this section are twice as large in size as any other words and statements required by this Act; and "(C) there is a multicopy 'informed consent form' which is deemed part of the label for the purpose of this Act; and "(D) a copy of each and every executed informed consent form and a written record of each and every attending physician's prescription for such drug is submitted by the attending physician to the Secretary at such times and in such form as the Secretary may require but not less than four times a year. Each and every executed informed consent form and prescription record submitted to the Secretary shall contain both the attending physician's license number and the name of the State which issued such license number; and "(E) a copy of each and every prescription for such drug which has been presented to a pharmacist is submitted by the pharmacist to the Secretary at such 65-596 76-2 |