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Beyond the pill?

It has been twenty-five years since the landmark Supreme Court decision in Griswold v. Connecticut brought contraceptive use under a constitutionally protected fight to privacy. However, according to a recent publication by the Committee on Population for the National Research Council of the Institute of Medicine, "since the introduction of the pill and the IUD in the early 1960s, no fundamentally new contraceptive methods have been approved for use in the United States," in marked contrast to many innovative approaches in foreign countries. Why? In Developing New Contraceptives: Obstacles and Opportunities, the NRC report cites four factors--"the social benefits of contraception, the complexity of contraceptive-related risks and benefits, the problems of evaluating the uncertain impact of long-term contraceptive use, and the effects of uncoordinated and sometimes discrepant public policies"-that together work to restrict the availability of contraceptive products in the U.S.

The "social benefits" of a wider array of accessible and safe contraceptives, according to the report, would include a substantial impact on problems of unintended pregnancy, unwanted children, and high rates of abortion. For example, some 1.6 to 2 million "accidental" pregnancies occur on an annual basis, with perhaps one-half of the nation's 1.5 million yearly abortions attributable to contraceptive failure. Hence, the report's authors conclude, "the stronger the desire to reduce abortion, the greater should be the investment to develop new methods of contraception" (pp. 22-23).

What stands in the way of developing new methods has to do fundamentally with the regulatory and legal ethos of the U.S. The report notes that the Food and Drug Administraton imposes a more stringent standard of safety for contraceptives than for other drugs and devices attributable to an unduly narrow risk-benefit analysis. Most FDA reviews concern the impact of a drug on a specific health condition or illness, not as with contraceptives, its impact on a healthy user irrespective of alternatives. The committee thus proposes a regulatory modification that would allow FDA approval even of drugs or devices that present risks, so long as "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" (2-3).

There is, moreover, only one major U.S. company currently doing research on contraceptives, Ortho Pharmaceuticals, in part because research and development costs can be extensive (up to $50 million) with no promise, due to regulatory review that can extend for fifteen years, of immediate financial return. The more prominent deterrent for such companies, however, is the fear of monumental losses from product liability lawsuits, such as the $275 million in claims paid that drove A.H. Robins into bankruptcy following discovery of disease, injury, and even death from use of its Dalkon Shield IUD. ($2.5 billion is currently in reserve for pending claims.) To counteract this, the report proposes that companies receive a "limited defense" from liability for contraceptive drugs and devices that have received EDA. approval.

Ethical values, including the views of religious traditions, seem to the committee not to pose a major obstacle to the development of new contraceptives, notwithstanding concerns about racism, sexism, and medicalization historically associated with the implementation of new birth control devices and programs. However, certain alternatives available in foreign countries, such as RU-486 or Norplant, could be considered morally suspect in the U.S. because they may blur important lines between abortion and contraception or sterilization and contraception. Even given broad support among the public for safer and more effective birth-control, a complex interrelation of policy, law, and ethics may well fulfill the report's prediction that "the prospects for having one or more fundamentally new methods available in the United States by the year 2000 are negligible" (39).-CSC
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Title Annotation:National Research Council report on contraception
Author:Campbell, Courtney S.
Publication:The Hastings Center Report
Date:May 1, 1990
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