Good morning! Kamala Harris breaks her silence after the election, Mexico's president Claudia Sheinbaum warns Trump against tariffs, and Fortune's Nina Ajemian reports on the state of male birth control—amid a tumultuous political environment for women's health and drug approvals. Have a restful weekend.
- In control. For years, advocates of reproductive freedom have been waiting for the arrival of male birth control (besides condoms and vasectomies). New options are finally getting closer to market—just as the second Trump administration enters the White House.
This is an issue on which the Trump White House could be a bit of a wildcard. On the one hand, the conservative roadmap Project 2025 threatens access to birth control for women, from allowing employers to opt out of covering it to limiting the contraceptive methods that can be covered under the Affordable Care Act. But male birth control has the luxury of being “removed from the whole debate” about abortion, says Darlene Walley, CEO of Next Life Sciences' Plan A, a male contraceptive in development. Most women know that treatments for men and women are often viewed differently, like how insurers have covered birth control compared to Viagra. Trump's Health and Human Services nominee Robert F. Kennedy Jr., meanwhile, is poised to overhaul the FDA and its drug approvals process just as new treatments seek the FDA’s signoff.
“We're in a time of transition, and the time is right for male contraception to really move out and get onto the market,” says Heather Vahdat, executive director of advocacy group the Male Contraceptive Initiative. There have been efforts made to get products on the market before, but no male contraceptive has cleared phase three trials. A lack of funding from pharmaceutical companies and severe side effects have gotten in the way. (Men have been more reluctant to tolerate side effects and treatments have been harder to get approved because pregnancy does not pose a physical risk to men.)
One of those birth control methods is Next Life Sciences’ Plan A, a non-hormonal, reversible contraceptive for men that lasts 10 years and is inserted in an outpatient procedure. Expected to enter clinical trials in the first quarter of 2025, Plan A uses a hydrogel that acts like a filter to stop sperm from moving through the vas deferens. The company plans for its FDA submission, approval, and commercialization to go through in 2027. “We're hoping that by giving the other half of the population the ability to participate in birth control that we can have a profound effect on pregnancies,” Walley says. Another is Contraline, which is also developing a hydrogel—this one’s called ADAM—and has been in human clinical trials for two years with FDA approval anticipated by 2027.
It may not be fair that male birth control gets to be considered a topic separate from abortion rights while women’s birth control is wielded as a political flashpoint, but the introduction of male contraceptives can still ultimately benefit women. Even founders of women’s health companies see it that way. “My passion project after this business would be making male birth control mainstream because I just think it's so unfair that it all falls on women,” says Jamie Norwood, cofounder of the women’s health brand Winx.
“Male contraception is a female reproductive health product,” argues Vahdat. “The goal will be to stop referencing it as male versus female contraception. Any contraception is ultimately trying to prevent an unintended pregnancy.”
Nina Ajemian
nina.ajemian@fortune.com
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Correction, Nov. 30, 2024: A previous version of this article misstated the timing of Contraline's human trials.
