Medicines360’s long and winding, $82 million road to create and distribute $50 birth control

abcnews.go.com:

Drugs and medical devices rarely come from the nonprofit world

Drugs and medical devices rarely come from the nonprofit world. There are more than 2,600 for-profit pharmaceutical companies in the United States, but only three nonprofits have products on the American market.

One of them is Medicines360, which in 2015 became the first nonprofit to introduce a medical device — an IUD. The genesis of the device came from an anonymous foundation that saw one of the most effective and reversible birth-control methods, the hormonal IUD, was too expensive for most women. Even insured women could be billed copays of up to $1,000.

In 2008, the foundation (which Bloomberg reported was the Susan Thompson Buffett Foundation) partnered with pharmaceutical scientist and MacArthur fellow Victoria Hale and decided to make a six-year, $82.2 million investment to develop a low-cost hormonal IUD through a nonprofit company.

“The real goal of the donor and of Medicines360 was to provide this product to safety net clinics at a very, very affordable price,” said Medicines360’s Autumn Ehnow, referring to health care sites that serve uninsured patients.

Medicines360 recently issued a report summing up what did and did not work in the seven years since it distributed devices for $50 apiece. The organization recounts meeting its goals: It expanded access to the device and introduced competition to the market and thus lowered prices.

However, it also faced unanticipated roadblocks, including the discovery that a low-cost product did not necessarily guarantee market adoption. Substantial challenges included a tax code and Food and Drug Administration regulations unfavorable to nonprofit pharmacies, a lack of access to investment, middlemen who