With FDA Nod, Nonprofit Drug Firm Launches New IUD—And New Model

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the Dalkon Shield. It was sold in the 1970s, caused 17 deaths and 200,000 injuries, and was taken off the market a few years later. Its maker declared bankruptcy in the 1980s under the weight of hundreds of thousands of lawsuits.

With decades gone by, women have begun to return to the IUD. In the 2011-2013 time frame, 6.4 percent of women using contraception were using IUDs, nearly double the rate of 2006-2010, according to a CDC study. The rate among women aged 15 to 24, a key group in the effort to reduce unintended pregnancy, jumped to 5 percent in 2011-2013 from 0.6 percent in 2002.

But problems remain. For instance, the upfront cost is often too much for lower-income women, even though the accumulated cost of birth control pills over the several years an IUD stays in place is higher, according to Weir.

Assistance programs for low-income patients can also be cumbersome. Requesting a product for free can be a long process and cumbersome for the company fielding one request at a time. “We’re suggesting a different model,” says Weir. Medicines360 would sell the IUD to clinics and other public sector outlets at a set subsidized price and let the clinics do the per-patient pricing, which often happens on a sliding scale.

There are still lingering doubts about IUDs and some doctors won’t perform the procedure, says Weir. Part of 360’s work will be to “help remove the hurdles at the doctor level” with PR, education, and training.

Medicines360 is a nonprofit but when I ask Weir about pricing and sales strategies, it provokes a burst of capitalist competitiveness: “We won’t give away all our strategy,” she says. “Bayer is dying to know the answers,” meaning Bayer Healthcare, which has two approved IUDs on the market.

Weir is also tight-lipped about future plans. Medicines360’s IUD business will start in the U.S. and, if successful, expand to developing countries, where the nonprofit has product rights. (It’s targeting Kenya first.)

There are other women’s health indications “beyond contraception,” but Weir declines to get more specific. “First we have to show the model works here,” she says. “Hopefully by the end of this year we’ll be able to show the impact.”

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