Evofem and Agile are both scrambling to stave off a similar fate. So when Pelletier rose at 4 a.m. In December, TherapeuticsMD licensed out its women’s health products and laid off its remaining staff. “It’s pretty bad-and it’s just rampant,” says Mara Gandal-Powers, director of birth control access and senior counsel for the National Women’s Law Center. “Health insurance companies are not covering newer products the way they’re supposed to.” But insurers’ decisions are making it financially impossible for small contraceptive manufacturers to survive, according to dozens of Fortune interviews with pharma executives, patients, doctors, current and former government officials, and nonprofit experts. Wade era, access to birth control is more important than ever. The result is a climate that stifles innovation and further restricts the health care available to the 73 million U.S. Most private health care plans are not fully covering about 50% of contraceptive products approved by the FDA after 2011, a damning October report from the U.S. But in practice, they simply don’t-especially for newer, more expensive forms of birth control.
#INCONTROL MEDICAL GEL INGREDIENTS FULL#
Since 2012, the Affordable Care Act has mandated that insurers cover the full costs of women’s contraception. All three of those companies won FDA approval for new contraceptives in the past five years-only to discover that most big insurance companies would not fully cover their products, despite a federal law requiring them to do so. women who use contraception-have come from a broken health care system. Investors and large pharma companies have largely abandoned women’s health, leaving the development of new contraceptives to small, scrappy specialists like Evofem, Agile Therapeutics, and TherapeuticsMD. But the worst body blows-to Evofem, to the handful of other companies in its critical market, and to the 47 million U.S. Some of these dire problems are of Pelletier’s own making. Now some patients are casting doubts on Phexxi’s basic effectiveness, claiming in online reviews that they have gotten pregnant while using the gel.
#INCONTROL MEDICAL GEL INGREDIENTS TRIAL#
A crucial clinical trial failed in October, dooming Pelletier’s efforts to expand Phexxi’s market. Its shares have traded for pennies since last spring. Evofem more than tripled its sales in the first nine months of last year, to $16.7 million-but it lost $68.4 million over that same period and is carrying $84 million of debt. “They want to believe in her.”īut the past two years have stretched even Pelletier’s ability to win over skeptics. “She gets people to want to be a part of what she’s doing,” Barrans says. Whether talking to lawmakers, judges for an upcoming TEDxSanDiego talk, or the head of the Food and Drug Administration, Pelletier is always her product’s savviest cheerleader, never missing an opportunity to promote its feminist vibes. She favors bold clothing, including T-shirts with slogans like “No laws exist to control men’s bodies.” While she’s slight of build and conventionally pretty-her blonde hair, which she lost to chemo in 2018, has grown back long enough to pull into a ponytail-her presence fills up a room. In person, Pelletier often erupts into dramatic motion-whipping her thick-framed black glasses off to accentuate a point, waving her arms to literally keep the motion-sensitive lights on in Evofem’s offices. Ever,” says Russell Barrans, a Bayer veteran who in 2021 retired as Evofem’s chief commercial officer.
“I’ve never met a person in my life with as much energy as this woman. She then spent seven years gritting through the final stage of the expensive and often frustrating FDA-approval process-raising almost $500 million from investors and taking the company public-before it could sell a single prescription.
Pelletier, 53, was a women’s health veteran and nonprofit CEO when she joined what became Evofem in 2013. More than 100,000 people have gotten a prescription for Phexxi since it launched in late 2020 millions more have watched its $30 million viral commercial. Its first and only product is a contraceptive gel called Phexxi, which Evofem markets to millions of women eager for a birth control option without hormones. It should have been a day of celebration-or at least marketing synergy-for the CEO of Evofem Biosciences, a women’s health company with an unapologetically sex-positive mission. Valentine’s Day in San Diego this year dawned cold and grim for Saundra Pelletier.
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