A coalition of hospital groups made good on its plan to set up a nonprofit generic drugmaker Thursday.
Civica Rx has been formally established as a nonprofit organization headquartered in Utah. Seven health organizations representing 500 hospitals – Catholic Health Initiatives, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health and Trinity Health – will serve as initial governing members. Other participating health systems will be announced later this year, while the Department of Veterans Affairs will also work with the new organization. Meanwhile, three philanthropic groups – the Laura and John Arnold Foundation, the Peterson Center on Healthcare and the Gary and Mary West Foundation – have each contributed $10 million. Amgen’s former chief quality officer, Martin VanTrieste, will serve as CEO. The plan to set up the company was announced earlier this year.
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“We are creating a public asset with a mission to ensure that essential generic medications are accessible and affordable,” VanTrieste said in a statement. “The fact that a third of the country’s hospitals have either expressed interest or committed to participate with Civica Rx shows a great need for this initiative.”
The group has identified 14 generic hospital-administered generic drugs that it will initially focus on, operating as a Food and Drug Administration-approved manufacturer and either making the drugs itself or through contract manufacturing organizations. The initial goal will be to stabilize the supply of drugs administered in hospitals that have fallen into chronic shortage situations, having its first products on the market as early as next year.
Other nonprofit drugmakers have arisen as well. In June, the Bill and Melinda Gates Foundation announced the creation of the Bill and Melinda Gates Medical Research Institute, which will develop products for diseases that plague developing countries, such as malaria, tuberculosis, enteric and diarrheal diseases.
According to the American Society of Health-System Pharmacists, more than half of shortages stem from unknown reasons, while 30 percent result from manufacturing issues, followed by supply and demand issues, natural disasters, problems with raw materials and discontinuations. Hurricane Maria also played a role when it devastated Puerto Rico’s pharmaceutical manufacturing industry, resulting in shortages of drugs as well as items like IV bags.
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ASHP statistics indicate that the number of new shortages climbed from 70 in 2006 and peaked at 267 in 2011, but was 146 last year and has reached 95 this year, as of June 30. However, the number of active drug shortages has increased, hovering around 174-176 between the second half of 2016 and third quarter of 2017 and rising to 202 and 224 in the first and second quarters of this year. Antibiotics, chemotherapy, autonomic, cardiovascular, central nervous system, electrolytes, EENT, gastrointestinal and hormone drugs are commonly affected classes.
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