Testimony of Father Joseph C. Howard, Jr.
Food and Drug Administration
June 29, 2000
I serve as the executive director of the American Bioethics Advisory Commission,
a division of American Life League, Inc., in Stafford, Va. There is no financial
association with any pharmaceutical companies who manufacture oral contraceptives.
I speak to you today regarding the possibility of oral contraceptives being made
available over the counter that would not require a prescription by a physician.
Because of serious side effects and complications associated with the use of oral
contraceptives, it is absolutely essential that physicians maintain control of who
has accessibility to them. It is therefore imperative that oral contraceptives not
be made available over the counter. From a scientific perspective alone, it is clearly
in the best interest of women that oral contraceptives remain available by prescription
only where physicians can monitor their patients accordingly.
The use of oral contraceptives is associated with increased risks of serious
conditions including the following:
- Thromboembolic disorders and other vascular problems such as myocardial
infarction, thromboembolism and cerebrovascular diseases
- Hepatic neoplasta
- Ocular lesions
- Gallbladder disease
- Carbohydrate and lipid metabolic effects
- Hypertension
- Headache
- Bleeding irregularities
The risk of morbidity and mortality increases significantly in the presence of
other underlying risk factors such as hypertension, hyperlipidemias, obesity,
and diabetes. While it is true that many of these deleterious physiologic effects
are associated with the use of oral contraceptives containing higher formulations
of estrogens and progestogens, the effects of long-term use of oral contraceptives
containing lower formulations of both estrogens and progestogens remains to be
determined.
One grave concern that exists if oral contraceptives were made available over the
counter is the predicted significant increase in STDs—particularly HIV.
Large numbers of high school and college students engage repeatedly in high-risk
sexual behaviors not realizing or accepting the fact that they are candidates to
contract such diseases that can have devastating consequences on their lives. Having
taught high school and college biology, physiology, philosophy and theology for
the past ten years, I am acutely aware that these young people would probably be
most affected by increases in STDs because many of them are unaware or in denial
that such effects are applicable to them in their lives. It is very common for
both high school and college students in America to be completely unaware that at
this time in America, HIV is most rapidly spreading in heterosexuals in the high
school and college populations. We must not and cannot allow our youth to be exposed
to such risks because they are the future leaders of our country. We must do
everything that is ethically appropriate to protect them and prepare them to assume
leadership positions in the United States of America. Making oral contraceptives
available over the counter can only contribute to the detriment of our youth and
subsequently our country. It would clearly be an unjust practice especially in
regard to our young people as well as women in general. In closing, I strongly urge
that the FDA not make oral contraceptives available over the counter in America.
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