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74. Lila D56 415

Regulation of DES

CONTENTS

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S. 963, as introduced-----

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APPENDIX

Schmidt, Alexander M., M.D., Commissioner, Food and Drug Administra-

tion, Public Health Service, Department of Health, Education, and Wel-

fare, prepared statement---

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.,

-prepared statement-------

Seife, Marvin, M.D., Director of the Generic Drug Division, Bureau of

Drugs, Food and Drug Administration, curriculum vitae of_------

Rauscher, Frank J., Jr., Ph. D., director, National Cancer Program, Na-

tional Cancer Institute, National Institutes of Health, prepared state-

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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,

November 1971-------

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

Michigan ------

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,

1975 (with attachments)----

Furman, Robert H., M.D., vice president, Lilly Research Laboratories,

prepared statement (with attachments)---

Tablicaps, Inc., Robert L. Pillarella, president, prepared statement (with

attachments) ----

Regulation of Diethylstilbestrol (DES), 1972, excerpt from Health Sub-

committee hearing, July 20, 1972----

Text of:

S. 963, as reported.

Senate Report 94–264-

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REGULATION OF DIETHYLSTILBESTROL (DES), 1975

THURSDAY, FEBRUARY 27, 1975

U.S. SENATE,
SUBCOMMITTEE ON HEALTH OF THE
COMMITTEE ON LABOR AND PUBLIC WELFARE;
SUBCOMMITTEE ON ADMINISTRATIVE PRACTICE AND
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:]

Str. CONGRESS

91T CONGRESS

IST SESSION

S. 963

IN THE SENATE OF THE UNITED STATES

SEARCH 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 pro

hibit the administration of the drug dictlıylstilbestrol (DES) to any animal intended for use as food, and for other purposes.

Be it enacted bij the Senate and FIouse 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 9 (DES) to any animal intended for use as food or any animal

oduct of which is intended for use as food.

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