AMERICAN JOURNAL OF
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Editorials Health February 1976 Volume 66, Number 2
Established 1911
Do-it-Yourself Pregnancy Testing Editor's Note: Not long ago we received manuscript evaluating a test for pregcalled Ova 11. The report, published on page 166 of this issue, demonstrates that if a wvoman wvants to know hether or not she is pregnant, tossing coin wvould give her as valid an answer as performing this particular test. The issues surrolnding pregnancy tests and their sale by prescription onlv or over-the-counter are complex and convoluted. We solicited the legal and medical comments wthich followt. a
EDITOR Alfred Yankauer, MD, MPH
EDITORIAL BOARD
Michel A. Ibrahim, MD, PhD (1977) Chairman Faye G. Abdellah, PhD (1977) Rashi Fein, PhD (1978) Ruth B. Galanter, MCP (1977) H. Jack Geiger, MD, MSciHyg (1978) George E. Hardy, Jr., MD, MPH (1978) C. C. Johnson, Jr., MSCE (1977) M. Allen Pond, MPH (1976) Pauline 0. Roberts, MD, MPH (1976) Ruth Roemer, JD (1978) Sam Shapiro (1976) Robert Sigmond (1976) Jeanette J. Simmons, MPH, DSc (1978) David H. Wegman, MD, MSOH (1976) Robert J. Weiss, MD (1977) STAFF
William H. McBeath, MD, MPH Executive DirectorlManaging Editor Allen J. Seeber Director of Publications Doyne Bailey Assistant Managing Editor Deborah Watkins Production Editor
AJPH February, 1976, Vol. 66, No. 2
nancy,
a
The Legal Perspective
...
A Federal Court in New Jersey recently ruled that the Food and Drug Administration could not require scientific demonstration that a do-it-yourself pregnancy diagnosis kit was effective. The result could be unlimited marketing of this product, "Ova II", and similar products, even though Ova II is unreliable and based on the discredited rationale that early pregnancy can be detected by measuring estrogen levels in the urine. At stake in the case is FDA's ability to police a host of products which are not "drugs" in the technical, medical sense but which are closely related to personal health care and treatment. The basic authority FDA has had since 1938 over "new drugs" has been the requirement that manufacturers submit, prior to marketing, a new drug application which contains scientific demonstration that the product is safe and effective. This requirement is at the core of FDA's ability to prevent injury. Without it, drugs would be able to be marketed until FDA had scientific proof in hand that a product was definitely unsafe or ineffective, an unlikely event since FDA does not have the budget necessary to conduct such tests on individual products. The courts have been sympathetic to FDA's efforts to protect the public from untested products, and in 1969 the Supreme Court in the Bacto-Unidisk caseI defined "'new drug" liberally to include an antibiotic sensitivity disc, which never touched the body but was used to determine which antibiotic should be prescribed for an infected patient. The New Jersey judge, however, stated that Ova II was not a drug. First, he explained, Ova II is used outside the body and "does not involve the injection or ingestion of any material in the human body itself;" second, drugs are used for disease but Ova II is used for pregnancy which is a "normal physiological function, and not a disease;" and further, pregnancy diagnosis "is no more than a test for news, which may be either good news or bad news depending on whether pregnancy is wanted or not." The judge apparently felt that full-term pregnancy was an inevitable condition to be undergone without altered behavior, possibly because of his belief, expressed in the opinion, that all pregnancies except one have occurred due to "original sin".2 129
EDITORIALS
A pregnancy test does have direct implications for the health care of any woman and for the treatment of abnormal pregnancies or pregnancies of women in poor health. It is not merely "news". There are many good reasons for diagnosing pregnancy as soon as possible, all of which are important to the health of the woman. Early diagnosis is important for those seeking induced abortions, in order to minimize complications and delay. Early knowledge of pregnancy is crucial for women with hypertension, diabetes, heart disease, or renal disease, both for their own health and well-being and for normal development of the fetus. Early diagnosis also helps women avoid any potentially damaging exposure to xray, aspirin, or sex hormones.3 Consumers should be able to buy pregnancy diagnosis kits without a prescription, and the Ova II decision does allow continued over-the-counter sales. However, consumers gain little and risk much by using tests which are not reliable and cannot be regulated adequately by FDA. Apart from its power to regulate "new drugs" on a premarket basis or to ban drugs which lack evidence of safety and effectiveness. FDA has limited power over other medical products, the power to ban once it can prove that the product is harmful or ineffective. As a practical matter, this power is rarely exercised because the tests needed to document the harm or inefficacy are not conducted, due to budgetary limitations. FDA's budget for those medical devices which are not deemed "drugs", for example, is only $6 million, so manufacturers can and do market worthless products with
might also jeopardize FDA's licensing of other pregnancy tests-such as those based on measuring chorionic gonadotropin in the urine-because "biological products" under the authorizing Public Health Services Act are defined in part by their applicability to the treatment or prevention of disease.5 Medical devices legislation is now under consideration in the Congress. The final shape of this legislation had not been determined when the Journal went to press, but it probably will not significantly expand FDA's authority in most situations-as stated earlier, FDA has had the power to regulate most devices through its ability to deem them "new drugs" -and it may impede FDA because of elaborate procedural requirements and compulsory advisory committees. However, the bills in both the House of Representatives and the Senate define medical devices as instruments "for use in the diagnosis of disease or other conditions." Perhaps the slight addition of the words "or other conditions" will deter judges in the future from decisions like Ova II. Whether or not the new legislation passes, it is hoped that Ova II is merely a temporary aberration from a long line of court decisions which show a keen awareness of the damage which unproven health products can wreak.
ANITA JOHNSON, JD
impunity.
Ms. Johnson is an attorney with the Public Citizen's Health Research Group, 2000 P Street, NW, Washington,VD.C. 20036
Under the New Jersey judge's reasoning, however, it is unlikely that FDA could act against Ova II even if it could spend the money for the studies needed, since medical devices are defined by the Food, Drug and Cosmetics Act as "instruments, apparatus, and contrivances, intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or affect the structure or any function of the body of man or other animals" -exactly the same criteria as the drug definition, with the addition of the words "instruments, apparatus and contrivances."4 The reasoning
1. 394 United States Code, 784 2. Unpublished opinion of Judge Vincent P. Biunno, U.S. District Court for the District of New Jersey, Civil No. 745-72, July 16, 1975. 3. These points were made in affidavits from medical experts, filed by FDA in the case. 4. 21 United States Code, 321(h). 5. 42 United States Code, 262.
REFERENCES
The Medical Perspective... The recent decision by a Federal Judge in New Jersey that the U.S. Food and Drug Administration could not restrict the sale of a do-it-yourself pregnancy test has brought to the fore the issue of the availability of pregnancy tests for self-use by women. Over the past 15 years pregnancy tests have undergone a technological revolution. The Aschheim-Zondek type tests involved the sacrifice of various animals and were so highly complex as to make the question of self-testing a moot point. Their replacement has been the immunologic test for chorionic gonadotropin which has been refined into a highly accurate, simple agglutination inhibition 2-minute slide test that can be performed by any person who can read the instructions. One such test, Pregnosticon Dridot, comes in 130
small complete test kits of 25's and 100's that require no refrigeration or other materials and may easily be sent through the mails. For some time prior to the recent Federal Court decision a flourishing self-pregnancy testing underground has existed in the women's health movement. Baker, et al, in a study reported in this issue of the Journal,' have given a negative evaluation of one Do-It-Yourself Pregnancy Test (Ova II). Their report can only put this particular test to rest (assuming FDA's appeal is upheld by higher courts). The issue of do-it-yourself pregnancy testing is still very much alive. Immunologic slide tests are highly accurate and can be used by women to diagnose their own pregnancies. It appears quite feasible that such tests could be marketed and AJPH February, 1976, Vol. 66, No. 2
_ri 0
Editorials Health February 1976 Volume 66, Number 2
Established 1911
Do-it-Yourself Pregnancy Testing Editor's Note: Not long ago we received manuscript evaluating a test for pregcalled Ova 11. The report, published on page 166 of this issue, demonstrates that if a wvoman wvants to know hether or not she is pregnant, tossing coin wvould give her as valid an answer as performing this particular test. The issues surrolnding pregnancy tests and their sale by prescription onlv or over-the-counter are complex and convoluted. We solicited the legal and medical comments wthich followt. a
EDITOR Alfred Yankauer, MD, MPH
EDITORIAL BOARD
Michel A. Ibrahim, MD, PhD (1977) Chairman Faye G. Abdellah, PhD (1977) Rashi Fein, PhD (1978) Ruth B. Galanter, MCP (1977) H. Jack Geiger, MD, MSciHyg (1978) George E. Hardy, Jr., MD, MPH (1978) C. C. Johnson, Jr., MSCE (1977) M. Allen Pond, MPH (1976) Pauline 0. Roberts, MD, MPH (1976) Ruth Roemer, JD (1978) Sam Shapiro (1976) Robert Sigmond (1976) Jeanette J. Simmons, MPH, DSc (1978) David H. Wegman, MD, MSOH (1976) Robert J. Weiss, MD (1977) STAFF
William H. McBeath, MD, MPH Executive DirectorlManaging Editor Allen J. Seeber Director of Publications Doyne Bailey Assistant Managing Editor Deborah Watkins Production Editor
AJPH February, 1976, Vol. 66, No. 2
nancy,
a
The Legal Perspective
...
A Federal Court in New Jersey recently ruled that the Food and Drug Administration could not require scientific demonstration that a do-it-yourself pregnancy diagnosis kit was effective. The result could be unlimited marketing of this product, "Ova II", and similar products, even though Ova II is unreliable and based on the discredited rationale that early pregnancy can be detected by measuring estrogen levels in the urine. At stake in the case is FDA's ability to police a host of products which are not "drugs" in the technical, medical sense but which are closely related to personal health care and treatment. The basic authority FDA has had since 1938 over "new drugs" has been the requirement that manufacturers submit, prior to marketing, a new drug application which contains scientific demonstration that the product is safe and effective. This requirement is at the core of FDA's ability to prevent injury. Without it, drugs would be able to be marketed until FDA had scientific proof in hand that a product was definitely unsafe or ineffective, an unlikely event since FDA does not have the budget necessary to conduct such tests on individual products. The courts have been sympathetic to FDA's efforts to protect the public from untested products, and in 1969 the Supreme Court in the Bacto-Unidisk caseI defined "'new drug" liberally to include an antibiotic sensitivity disc, which never touched the body but was used to determine which antibiotic should be prescribed for an infected patient. The New Jersey judge, however, stated that Ova II was not a drug. First, he explained, Ova II is used outside the body and "does not involve the injection or ingestion of any material in the human body itself;" second, drugs are used for disease but Ova II is used for pregnancy which is a "normal physiological function, and not a disease;" and further, pregnancy diagnosis "is no more than a test for news, which may be either good news or bad news depending on whether pregnancy is wanted or not." The judge apparently felt that full-term pregnancy was an inevitable condition to be undergone without altered behavior, possibly because of his belief, expressed in the opinion, that all pregnancies except one have occurred due to "original sin".2 129
EDITORIALS
A pregnancy test does have direct implications for the health care of any woman and for the treatment of abnormal pregnancies or pregnancies of women in poor health. It is not merely "news". There are many good reasons for diagnosing pregnancy as soon as possible, all of which are important to the health of the woman. Early diagnosis is important for those seeking induced abortions, in order to minimize complications and delay. Early knowledge of pregnancy is crucial for women with hypertension, diabetes, heart disease, or renal disease, both for their own health and well-being and for normal development of the fetus. Early diagnosis also helps women avoid any potentially damaging exposure to xray, aspirin, or sex hormones.3 Consumers should be able to buy pregnancy diagnosis kits without a prescription, and the Ova II decision does allow continued over-the-counter sales. However, consumers gain little and risk much by using tests which are not reliable and cannot be regulated adequately by FDA. Apart from its power to regulate "new drugs" on a premarket basis or to ban drugs which lack evidence of safety and effectiveness. FDA has limited power over other medical products, the power to ban once it can prove that the product is harmful or ineffective. As a practical matter, this power is rarely exercised because the tests needed to document the harm or inefficacy are not conducted, due to budgetary limitations. FDA's budget for those medical devices which are not deemed "drugs", for example, is only $6 million, so manufacturers can and do market worthless products with
might also jeopardize FDA's licensing of other pregnancy tests-such as those based on measuring chorionic gonadotropin in the urine-because "biological products" under the authorizing Public Health Services Act are defined in part by their applicability to the treatment or prevention of disease.5 Medical devices legislation is now under consideration in the Congress. The final shape of this legislation had not been determined when the Journal went to press, but it probably will not significantly expand FDA's authority in most situations-as stated earlier, FDA has had the power to regulate most devices through its ability to deem them "new drugs" -and it may impede FDA because of elaborate procedural requirements and compulsory advisory committees. However, the bills in both the House of Representatives and the Senate define medical devices as instruments "for use in the diagnosis of disease or other conditions." Perhaps the slight addition of the words "or other conditions" will deter judges in the future from decisions like Ova II. Whether or not the new legislation passes, it is hoped that Ova II is merely a temporary aberration from a long line of court decisions which show a keen awareness of the damage which unproven health products can wreak.
ANITA JOHNSON, JD
impunity.
Ms. Johnson is an attorney with the Public Citizen's Health Research Group, 2000 P Street, NW, Washington,VD.C. 20036
Under the New Jersey judge's reasoning, however, it is unlikely that FDA could act against Ova II even if it could spend the money for the studies needed, since medical devices are defined by the Food, Drug and Cosmetics Act as "instruments, apparatus, and contrivances, intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or affect the structure or any function of the body of man or other animals" -exactly the same criteria as the drug definition, with the addition of the words "instruments, apparatus and contrivances."4 The reasoning
1. 394 United States Code, 784 2. Unpublished opinion of Judge Vincent P. Biunno, U.S. District Court for the District of New Jersey, Civil No. 745-72, July 16, 1975. 3. These points were made in affidavits from medical experts, filed by FDA in the case. 4. 21 United States Code, 321(h). 5. 42 United States Code, 262.
REFERENCES
The Medical Perspective... The recent decision by a Federal Judge in New Jersey that the U.S. Food and Drug Administration could not restrict the sale of a do-it-yourself pregnancy test has brought to the fore the issue of the availability of pregnancy tests for self-use by women. Over the past 15 years pregnancy tests have undergone a technological revolution. The Aschheim-Zondek type tests involved the sacrifice of various animals and were so highly complex as to make the question of self-testing a moot point. Their replacement has been the immunologic test for chorionic gonadotropin which has been refined into a highly accurate, simple agglutination inhibition 2-minute slide test that can be performed by any person who can read the instructions. One such test, Pregnosticon Dridot, comes in 130
small complete test kits of 25's and 100's that require no refrigeration or other materials and may easily be sent through the mails. For some time prior to the recent Federal Court decision a flourishing self-pregnancy testing underground has existed in the women's health movement. Baker, et al, in a study reported in this issue of the Journal,' have given a negative evaluation of one Do-It-Yourself Pregnancy Test (Ova II). Their report can only put this particular test to rest (assuming FDA's appeal is upheld by higher courts). The issue of do-it-yourself pregnancy testing is still very much alive. Immunologic slide tests are highly accurate and can be used by women to diagnose their own pregnancies. It appears quite feasible that such tests could be marketed and AJPH February, 1976, Vol. 66, No. 2
