• Summary
• Credits

1. The Long Road of Contraceptive Development
• Testing Can Take Years
• Will Advances in Contraception Continue?
• Scope of This Report
2. Vaginal Rings
3. Transdermal Contraception
4. Contraceptive Implants
5. Combined Injectables
6. Condoms
7. Fertility Awareness-Based Methods
8. Oral Contraceptives
9. Intrauterine Devices
10. Transcervical Female Sterilization
11. Male Hormonal Contraception
12. Bibliography
13. Web Supplements

• Clinical trials assess effectiveness and safety of new contraceptives
• New low-dose DMPA formulation
• More long-term choices for men

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The Long Road of
       Contraceptive Development

A new contraceptive travels a long road before reaching the public. Most of today’s new contraceptives result from investments started 10 to 20 years ago. Most potential new contraceptives undergo extensive research and rigorous clinical trials as part of their development and must obtain government regulatory approvals before they become available to the public.

Regulatory decisions made by the US Food and Drug Administration (US FDA) and the European Medicines Evaluation Agency (EMEA) play an important role in the introduction of new contraceptive methods in developing countries as well as in the US and Europe (1). The contraceptives distributed by the US Agency for International Development (USAID)—one of the largest suppliers of contraceptives in the developing world—usually need approval from the US FDA before they can be offered to organizations that receive support from USAID (248). Many developing countries have their own approval or registration processes for new health care products, but, because they have limited regulatory infrastructure, they often rely on US or European regulatory approval as a guideline (270).

After receiving regulatory approvals, new contraceptive methods reach people in developing countries primarily through two routes. First, some new methods may be introduced into national family planning programs for distribution through public-sector clinics and nongovernmental organizations (NGOs), often with support from donor agencies such as the United Nations Population Fund (UNFPA) and USAID. Second, private pharmaceutical companies that develop contraceptive methods may contract with manufacturers and distributors that make them available for sale through pharmacies, private clinics, and other retailers.

Not all new methods will reach developing countries, however. For each new method that becomes approved, donors and country programs must weigh the added cost of introducing it against the added benefits for contraceptive users (212, 272). Many factors other than regulatory approval—including logistics infrastructure, service delivery systems, method characteristics, cultural norms, and user preferences—influence how soon a new method is introduced into a country, or whether it is introduced there at all (111).

Typically, even before clinical trials in humans start, potential new contraceptives face several years of preclinical testing involving test-tube, or “in-vitro” studies, followed by testing in live animals. Preclinical testing evaluates the safety of the drug, device, or materials used to make the proposed method. After completing preclinical testing, a research organization seeking US FDA approval submits to the regulatory agency an Investigational New Drug Application or an Investigational Device Exemption to begin clinical trials. The method then must undergo three or four phases of clinical trials (see Table 1).

Generally, companies prefer to introduce new contraceptives that are modifications of currently available products because they have already proven safe and effective and therefore require fewer clinical trials and less expense and time than developing completely novel approaches to contraception (74, 111). Most recent advances in contraception have been variants of existing methods. Still, it is biologically and technologically feasible to go further —to develop entirely new methods that are more effective, have fewer side effects, and are more acceptable than many methods currently in development (112) (see Web Supplement, “Novel Gene-Based Approaches Promise Dramatic Change in Contraception”).

Are pharmaceutical companies and other organizations making sufficient investments today to keep up with future contraceptive needs and to take advantage of scientific advances? Contraceptive research and development is funded primarily by the World Health Organization (WHO), the US National Institutes of Health (NIH), USAID, charitable foundations, and small private companies (112). Contraceptive research and development in the pharmaceutical industry in recent years has been done primarily in Europe or by smaller US companies.

Most large, for-profit manufacturers will pursue development of a potential contraceptive only if the estimated future profits are substantial enough to make up for the large investment costs (111, 112). Pharmaceutical companies tend to view the US market for contraceptives as saturated and potential markets in developing countries as unprofitable (205). Also, to justify investment in a new contraceptive method, the company must project that it could offer a better financial return than other investments could offer (231).

Companies also worry about lawsuits and liability associated with potential new contraceptives (17, 205). Risk is less tolerated in preventive medical products and approaches for healthy people—such as contraception—than in curative ones for sick people (111, 181, 231). Moreover, products related to reproduction often elicit emotional reactions and cause controversies that other medical products do not (181, 205). Family planning advocates have expressed concern that regulatory agencies hold contraceptives to more restrictive standards than other drugs or devices (35, 81, 181, 231).

To help compensate for diminishing pharmaceutical company investment, manufacturers of contraceptive products are collaborating with academic research centers and nonprofit organizations (111). International networks and public-private partnerships for contraceptive development have been instrumental in attracting and retaining donor and private-sector interest in contraceptive development (80, 112).

This report does not attempt to cover all new contraceptive methods that have been recently released or that are in research and development. The report focuses on selected innovations in contraceptives that are more effective, less costly to manufacture, easier to deliver, and that cause fewer side effects than currently available options. The report also covers some existing contraceptive methods that are not yet widely known or generally available, or that have recently been approved by the US FDA. Additional new methods, including innovative gene-based approaches and cervical barriers, are covered in a Web Supplement to this report, available at: http://www.populationreports.org/m19/supplements.

Disclaimer: The information provided on this web site is not official U.S. Government information and does not represent the views or positions of the U.S. Agency for International Development or the U.S. Government.