Medicines360 CEO battles for IUD access

The pharmaceutical business, as you might've heard once or 62,500 times during the ongoing run-up to the presidential election, is generally not known for its charitable inclinations. 

This perception might not necessarily be a fair one—the whole “list price/actual price” distinction seems lost on many audiences—but it sticks nonetheless. Perhaps that's why an interview with Medicines360 CEO Dr. Jessica Grossman feels less like a formal get-to-know-you chat and more like being on the receiving end of a passionate sermon.

That's a good thing. The nonprofit Medicines360 was founded (and funded to the tune of $74 million by an anonymous donor, revealed by Bloomberg Businessweek to be the Susan Thompson Buffett Foundation) in 2009 with a single aim in mind: to bring to market a low-cost IUD and make it accessible to women receiving birth control via Planned Parenthood, STD clinics, rural and inner-city clinics and other public-sector organizations. While approximately 60% of women using contraception take the birth-control pill, the pill is only effective when used correctly.

IUDs, on the other hand, rank among the most effective long-acting reversible contraception (LARC) devices—and, prior to Medicines360's arrival on the scene, there were only three on the market. The lack of competition drove prices sky-high; at around $600, those IUDs were, and are, too expensive for most publicly funded organizations. By comparison, the Medicines360 IUD, Liletta, costs those groups $50. (For private entities, the price differential between Liletta and the competition is not as profound.)

“What our funders heard for years was that at public-facing institutions, women—particularly indigent women—were hearing, ‘We love these LARCs, but we can't afford to have them on our shelves.' They ended up giving women the pill or nothing at all, then the women came back pregnant,” Grossman says.

As she relates this history, Grossman's voice bristles with frustration. Perhaps this is due in part to her personal and professional history of, as they say in the biz, getting stuff done. She received her medical degree from Thomas Jefferson University in Philadelphia but never practiced. “Halfway through my residency, I thought, ‘There's got to be a better way to impact patient care.' I admire physicians immensely, but for me there was something else out there,” she recalls. Around this time Grossman “heard about this Silicon Valley place” and relocated to the area, where she found work at a range of medical-technology companies.

The successes came quickly. At Gynesonics she oversaw a team that developed the first minimally invasive surgical device for fibroid tumors. Later, as president and CEO of Sense4Baby, she helped usher the company's fetal heart-rate monitor for high-risk pregnancies through the FDA-approval process.

After sitting on the board of Medicines360 since 2011, Grossman accepted the CEO post last July, a few months after the FDA approved Liletta. Originally licensed from a European company in 2009, Liletta underwent what Grossman characterizes as the largest clinical trial for an IUD on US soil (1,751 women). The trial was similarly uncommon in its goal. “It was all about access. It was designed to combat and dispel some of the myths associated with IUD use,” Grossman says.

Among them was the long-held belief that IUDs should not be inserted until a bevy of tests are conducted. During the trial, IUDs were inserted without waiting for test results; patients had the same outcomes as they did with the testing-related delay. “In the past, if women had to come back [to the clinic after asking for an IUD], they often came back pregnant. We showed there's no risk in doing same-day insertion,” Grossman explains. In March, the FDA approved Liletta for a three-year indication. Sales have since been brisk.

So who's to say it can't happen again? Grossman notes that Medicines360 hopes to expand its pipeline to include “anything that meets an unmet need in women's health.” Doing so will likely require partnerships of the kind it forged on Liletta. In 2013 Medicines360 teamed with a company that was ultimately swallowed up by Actavis for sales and distribution help.

“Typically you don't see many nonprofit pharmaceutical companies. I think we were in uncharted territory, and I think we still are,” Grossman says. “We're just 25 people. We're doing everything we can to get people to understand the importance of what we're doing.”

Dr. Jessica Grossman

CEO, Medicines360 (July 2015–present)

CEO and president, Sense4Baby (February 2013–March 2014)

Medical director, medical affairs, Ethicon Endo-Surgery (November 2010–February 2013)  

Co-founder, Materna Medical (January 2008–June 2010)

Founder, Gynesonics (January 2005–February 2008)