Getting contraceptives for men to the market will take pharma’s help

That the responsibility for preventing unintended pregnancy still lies almost exclusively with women remains one of the world’s great health inequities. Beyond condom use, vasectomy, and withdrawal, there are no other male-controlled methods of contraception, even though it’s an entirely feasible option. One of the biggest obstacles to the development of male contraceptives has been the lack of interest and involvement from pharmaceutical companies.

At a time when more governments are restricting access to female contraception, expanding male contraceptive options could help to make family planning more of a shared responsibility between women and men. And that’s becoming closer to reality.

I joined a group of researchers this week at the Second International Congress on Male Contraception in Paris to share updates on a range of new contraceptive products for men. These include implants, gels, pills, and injections. A large Phase 2b efficacy and safety study will begin this summer on a promising option: a transparent gel a man applies once a day to his shoulders and upper arms. The gel is designed to decrease a man’s sperm production without reducing his sexual drive or enjoyment. The trial is expected to enroll 420 couples in seven countries.

Whether this and other promising products ever come to market, however, will depend on whether we can overcome several key misconceptions about male contraception — and whether the pharmaceutical industry will overcome its longstanding reluctance to invest in contraception for men.

One basic misperception slowing the field is that new options aren’t needed because a number of contraception products already exist for women. The reality is that many women lack access to safe and affordable contraception. But even if female contraceptives were universally available, leaving men out of the responsibility for family planning is less than ideal.

Consider what may be the most compelling argument for male contraception: the extraordinarily and stubbornly high rates of unintended pregnancy. Worldwide, 44 percent of pregnancies — more than 90 million pregnancies each year — are unplanned. Safe, effective, and reversible tools for men to control their own fertility could represent a game-changer, and give new meaning and significance to the term “family planning.”

Another misperception is that men are not interested in, or are even afraid of, tools to control their own fertility. Research shows that’s not the case however, with as many as half of men surveyed saying they would use a male contraceptive if it is reversible and easy to use. And there is good reason to believe that willingness to use male contraception would increase once proven contraceptive tools for men are available.

Perhaps the greatest barrier to the development of male contraceptives has been the lack of interest and involvement from pharmaceutical companies. The costs of scientific discovery and research on the new contraceptive gel, for example, have been borne by the National Institutes of Health and my organization, the nonprofit Population Council. The World Health Organization’s Contraceptive Research and Development program and several universities also play an important role in supporting research on male contraception.

Government and philanthropic support for male contraceptives is important, but not enough. Today, this work struggles forward with little or no support from the pharmaceutical industry. That needs to change. Oft-cited and assumed perceptions that men would be unwilling to use male contraception or that the field would prove to be unprofitable are not borne out by the data. If a male method managed to be approved by the Food and Drug Administration in the next five years, market projections predict a market of $1 billion by 2024 with annual growth of 6 percent over the following 10 years.

Bringing safe and effective male contraception options to market could revolutionize the global contraception paradigm, attract millions more customers, and prevent untold numbers of unintended pregnancies, helping couples decide whether and when to have children, and how many.

In considering whether to develop a new drug, pharmaceutical companies consider the regulatory environment. When they look at male contraception, they see a global regulatory system that is largely unprepared to guide and support the study and approval of male contraceptive products. The good news is that the Phase 2b trial of the novel gel will help pave the way for future male contraceptive products to be evaluated by the FDA. Having clear guidance and policies from the FDA and the European Medical Agency around the regulatory process for male contraception, which exists for female contraception, will be transformational.

It’s past time for industry and regulators to catch up to the science. The potential for male contraception is huge. But as researchers gathered this week to compare data and promising new approaches to male contraception, the question on everyone’s lips was, “When will these products ever come to market?”

Régine Sitruk-Ware, M.D., is a distinguished scientist at the Population Council’s Center for Biomedical Research and a co-founder of the International Consortium of Male Contraception.