Drugs and medical devices rarely come from the nonprofit world.
for-profit pharmaceutical companies in the United States, but only three nonprofits have products on the American market., 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.
IUDs were saddled with a bad reputation in the United States due to a defective device, the Dalkon Shield, marketed in the 1970s, which caused severe infections and even deaths. Though other IUDs did not carry the risks of the Dalkon Shield, negative views of IUDs persisted for decades in the American market, and other manufacturers withdrew their products for fear of litigation and because of low demand and a strict approval process.
“The barrier to U.S. market entry was not IP,” said Ehnow. “It was just purely no one had been interested or able to raise those kinds of funds.” Though the nonprofit predicted it would sell 100,000 devices to safety-net clinics and hospitals in its first year, its actual sales were less than half of that.
It is expecting two reports from the U.S. Department of Health and Human Services on nonprofit pharma, due within the year, as well as one from the Government Accountability Office, due at the end of 2024.
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Medicines360’s long and winding, $82 million road to create and distribute $50 birth controlDrugs 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.
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