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OCR for page 1
Executive Summary
Currently available contraceptive methods are not well suited to the religious,
social, economic, or health circumstances of many Americans and, therefore, a
wider array of safe and effective contraceptives is highly desirable. Important
individual and social benefits are associated with lower rates of abortion and
unwanted pregnancy, especially among teenagers, that new contraceptive meth-
ods might help to bring about. The Committee on Contraceptive Development
was appointed to explore organizational and policy issues affecting the develop-
ment of such new contraceptive technologies.
THE NEED FOR NEW CONTRACEPTIVES
The committee found that important changes have taken place in contraceptive
research and development over the past two decades. All but one of the large U.S.
pharmaceutical companies formerly conducting research on new contraceptives
have withdrawn from the field. Partly as a result of this change, and partly as a
consequence of changing patterns of support from the federal government, non-
profit organizations and small firms have become more important for contracep-
tive development. Although these organizations have experienced some initial
difficulties, they are becoming better equipped to develop new products. Prog-
ress, however, has been slow and it is not clear whether these groups will have the
resources to discover, develop, and market fundamentally new methods success-
fully.
Although the rate at which new products will be developed cannot be forecast
precisely, significant innovations in contraceptive technology are currently being
1
OCR for page 2
2 DEVELOPl~G NEW CO=RACE~~ES
studied in the United States and in other countries. Moreover, important improve-
ments in contraception are already available to people in other countries; their
appropriateness in the United States should be considered.
New methods would help men and women meet the changing needs for
contraception that they face during the different stages of their reproductive lives.
An increase in the total number and type of contraceptive options available would
help to ensure a better, healthier match of methods to users. Furthermore, societal
needs change over time, and new methods could help societies address important
social problems, such as the prevalence of sexually transmitted diseases. The
significant gaps that currently exist in the range of available methods could be
filled, in part, by developing new, safe, effective, and acceptable contraceptive
methods for men, for breastfeeding women, for teenagers, for older women, and
for those with a particular health condition or illness.
Ensuring adequate and sustained financial and human resources is an impor-
tant step in strengthening the ability of existing organizations and scientists to
develop new contraceptives. Given the relatively small pool of scientists working
in this field, the committee believes that special attention should be given to
enhancing the training opportunities for young scientists interested in careers in
reproduction and contraceptive development.
FDA REGULATION OF CONTRACEPTIVE PRODUCTS
The committee concludes that recent policy changes by the Food and Drug
Administration (E7DA) have improved the review and regulation of contraceptive
products. Questions remain, however, about the standards of safety and effective-
ness applied to contraceptive products. For most drugs, the FDA reviews their
risks compared with their benefits against a specific health condition or illness. In
the case of contraceptive products, however, the FDA assesses the potential
impact of a contraceptive on healthy users, without sufficient recognition that the
risks associated with a particular contraceptive drug or device may be outweighed
by the advantages of the method for some users.
The committee believes more weight should be given to variations among
potential users that could influence their contraceptive practice. In addition, the
committee concludes that the FDA should increase the weight it assigns to
contraceptive effectiveness and convenience of use. Given the potentially serious
health consequences of an unwanted pregnancy resulting from contraceptive
failure, methods with fewer side effects are not necessarily safer if they have
higher failure rates. The social and health risk of pregnancy will be important
considerations for users and must be weighed in the calculation of the safety of
methods. The committee does not propose reducing the safety requirements
applicable to contraceptives. Instead, we propose adding new criteria to the
evaluation of safety to make it more specific to different groups of users.
The committee therefore proposes a change in policy with regard to FDA
OCR for page 3
EXECUTIVE SUMMARY 3
practices that it believes would contribute to contraceptive development: the
committee recommends that the FDA further revise its procedures for evaluating
new contraceptive products by recognizing special safety advantages of new
methods for identifiable groups not adequately served by already approved con-
traceptive methods. FDA should be prepared to approve a contraceptive drug or
device even if that drug or device presents a risk, if it can be shown that the new
contraceptive also offers a safety advantage for an identifiable group of users
when compared with that group's actual contraceptive practice, including nonuse.
Such a contraceptive should be indicated only for a well-defined population that,
in fact, is not adequately served by other contraceptives. The product's labeling
should discuss all significant risks presented by the contraceptive.
The effect of such changes might be that the FDA would view as adequate to
support approval a benefit-risk ratio currently viewed as inadequate to support
approval. Such an approval should be subject to conditions to help ensure that
approval will enhance the health of users of the new contraceptive. In order for
the FDA to make an adequate assessment that a contraceptive product is benefi-
cial, it needs feedback about its effects on the health of users. The committee's
recommendation that a comprehensive postmarketing surveillance system be
established is a good way to ensure systematic and timely feedback.
The committee does not consider an increase in the weight ascribed to contra-
cepiive effectiveness and convenience to be a major change in the FDA regulation
of contraceptives or a departure from the policy that the FDA applies with respect
to other drugs. Rather, we view it as an effort to make the FDA's regulation of
contraceptive drugs and devices more similar to its regulations of other drugs and
devices. The committee strongly endorses the FDA's paramount concern for the
safety of users of contraceptives, but we believe that concern can be most
effectively exerted by changing the current standard applied by the FDA for
approval of new contraceptives. The proposed change would still impose on
contraceptive products a safety standard more demanding than that for other
drugs and devices.
PRODUCTS LIABILITY LAW AFFECTING CONTRACEPTIVES
The committee also recommends a change in public policy related to liability
law that would contribute to the development of new contraceptives. Two aspects
of recent products liability litigation and its impact are significant in the context of
contraceptives: one is the unpredictable nature of litigation, which results in part
from the absence of stable and uniform national products liability rules and in part
from the often erratic character of the litigation system; the other is that, although
manufacturers may introduce evidence of compliance with FDA regulations in a
products liability lawsuit, this evidence is given no special status in most states.
FDA approval, for example, does not entitle the manufacturer to a presumption
that it acted with due care. Because of the length of time necessary for develop
OCR for page 4
4 DEVELOPING NEW CO=RACE~IVES
ment of a new contraceptive product and the costs of that development, manufac-
turers, in considering whether to remain in the contraceptive field, are likely to
give special attention to the prospects of extensive litigation. Without changes in
the products liability rules and procedures, it appears likely that even fewer firms
will allocate even fewer resources to contraceptive research and development.
The committee believes that the products liability rules can be changed to
remove most of their undue negative consequences for contraceptive develop-
ment without increasing the health risks of contraceptive users. The committee
has concluded that an aspect of a contraceptive drug or device that complies with
the requirements of federal food and drug law should not be determined to be a
defect or a breach of warranty under state law; that the manufacturer of that
contraceptive product should not be held negligent for complying with FDA-
approved designs or warnings; and therefore that the manufacturer of a specific
contraceptive drug or device should not be the source of compensation to some-
one injured by that aspect of the particular contraceptive drug or device. This
defense would not be available if the contraceptive manufacturer withheld rele-
vant information from the FDA in the approval process, or if information devel-
oped after approval was not reviewed by the FDA for purposes of determining
whether the contraceptive product, its marketing, or its labeling should be changed.
The committee also notes that the important issue of providing adequate compen-
sation to persons injured by defective products is part of a much broader question
of the adequacy of existing private and social insurance mechanisms, and as such
goes beyond the scope of this report.
The committee therefore recommends that Congress enact a federal products
liability statute that gives contraceptive manufacturers credit for FDA approval of
contraceptive drugs and devices. Pharmaceuticals and medical devices are unique
among products in the United States in the degree to which quality is regulated
before they are released in the market. Given that a system of careful premarket-
ing review exists, the necessity for liability as a quality control mechanism is
greatly reduced. When the FDA has considered the relevant health and safety
data on a contraceptive product, has approved the product, and has required
warning and instructions to accompany the product, it is sound national policy to
make this approval available to manufacturers as a limited defense and not to
penalize them for something they could not have known at an earlier point.
Because the statute would interact with postmarketing surveillance efforts, this
recommendation would be more compelling if formal postmarketing surveillance
studies were generally required.
CONCLUSION
There has been a tremendous growth in the use of modern contraceptives over
the past three decades. Concern about side effects and the effectiveness of exist-
ing methods and demand for safer, more effective, more convenient, and afford
OCR for page 5
EXECUTIVE SUMMARY 5
able contraceptives have also grown. The importance of these issues both in the
United States and in over countries is likely to increase in the decades to come.
But new birth control methods-even safer and more effective ones-will be of
little benefit if they are not accessible, if they are not delivered properly with
adequate screening and counseling, if they are not used, or if they are used
incorrectly.
Better education about human reproduction, sexuality, and contraception, shared
responsibility, and more open communication between parmers about sex, health,
and family planning are likely to increase motivation to use contraception and the
ability of individuals to use methods effectively. But, unless steps are taken now
to change public policy related to contraceptive development, contraceptive choice
in the next century will not be appreciably different from what it is today.
OCR for page 6
Representative terms from entire chapter:
contraceptive products
