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Manufacture Biosimilars, Small Molecules

For Patients, Not Profits

Back in January 2018, “Project Rx” was announced – an ambitious initiative to establish a not-for-profit generic drug company. Further exciting details have now emerged (1): the company will be called Civica Rx and will be headed by Martin Van Trieste, former chief quality officer at Amgen and number 2 on The Medicine Maker’s Power List of Industry Influencers (2) More than 120 health organizations – representing a third of national hospitals in the US – have expressed an interest in some sort of participation.

A huge number of generic medicines have been approved in the US, but shortages – and high prices – are still an issue, particularly for sterile, generic medicines considered “foundational” to hospitals (3). The American Society of Health-System Pharmacists has listed hundreds of compounds facing shortages (4) – but a clear problem is that demand is outstripping supply.

Van Trieste has described the company as “a public asset with a mission to ensure that generic medications are accessible and affordable.” Leading very much from the front, Van Trieste takes on the new role without compensation.

What are the facts?
  • Civica Rx will be an FDA-approved manufacturer that will either directly manufacture generic drugs or sub-contract manufacturing to reputable contract manufacturing organizations.
  • The company will seek to stabilize the supply of essential generic medicines administered in hospitals. 
  • A secondary goal is to boost competition within the generic market to lower the costs of crucial medicines.
  • 14 hospital-administered generic drugs will be targeted by the company as an initial focus.
  • The first products are expected to be on the market as early as 2019.
Who’s involved?
  • Catholic Health Initiatives 
  • HCA Healthcare 
  • Intermountain Healthcare
  • Mayo Clinic
  • Providence St. Joseph Health
  • SSM Health
  • Trinity Health
  • The US Department of Veterans Affairs
  • The Laura and John Arnold Foundation
  • The Peterson Center on Healthcare
  • The Gary and Mary West Foundation

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  1. BusinessWire, “Not-for-Profit Generic Drug Company Officially Established, Attracts Interest of More Than 120 Health Organizations,” (2018). Available at https://bit.ly/2CvyqHz. Last accessed September, 2018.
  2. The Medicine Maker, 2018 Power List. Available at https://themedicinemaker.com/power-list/2018/.
  3. S Barlas, “Frustration Over Generic Drug Shortages and Prices Prompts Federal and Private Actions: Health Systems Take Matters Into Their Own Hands, Pharmacy and Therapeutics, 43 (2018).
  4. ASHP, “Drug Shortages List”. Available at https://bit.ly/2L3zRNv. Last accessed September, 2018.

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