Commentary from Civica Rx CEO Martin VanTrieste:
We are halfway through Civica Rx’s first year. When I reflect on all that has happened since our company’s launch in September 2018, I am proud of what we have accomplished and more motivated than ever to deliver on our mission of making essential generic medications accessible and affordable.
With each new conversation we’ve had and with each new partnership we’ve forged in these early stages of Civica’s development, I am profoundly moved by the stories I hear about the impact of generic drug shortages on patients due to delayed surgeries and/or sub-optimal treatments. These include reports of weekly, sometimes daily huddles of hospital staffers who must triage alternative drug solutions for their patients instead of being able to use that time to provide excellent patient care. They include stories about patients rationing their own medicines. And they include stories from physicians who have had to tell patients they have a devastating illness and have also had to tell them that the best drug to treat them is not available due to a drug shortage.
Chronic generic drug shortages in the US have been a problem for over a decade. Yet, Civica’s strategy for reducing them is brand new and that’s one reason why public interest in Civica is high. Our momentum to date, and the fact that more than 200 drugs have been on and off the FDA’s shortage list in recent years, confirms the timely need for us to influence and help improve the way the generic drug marketplace works.
A Disruptive Enterprise
Civica exists in the public interest as a non-stock, non-profit corporation to address shortages of generic drugs while lowering their cost. The company was founded by seven leading hospital systems concerned about generic drug shortages and three philanthropic members passionate about improving healthcare. These “Governing” organizations make up Civica’s Board of Directors. In recent months, nearly 20 more health systems have joined Civica as Founding and Partnering members. In all, Civica’s membership consists of more than 800 hospitals across the US.
What makes Civica different from other generic drug companies is our commitment to transparency, a one-price-for all model regardless of hospital size, and a membership structure that is open to all. We are pro-competitive and are committed to eliminating uncertainty in the generic drug supply chain, in part by entering long-term contracts with both our health system partners as well as with multiple manufacturing partners in multiple locations, allowing us to set the demand and ensure that we have dedicated manufacturing capacity for the drugs we need to deliver.
Civica will focus first on providing 14 much needed medications, mostly sterile injectables such as anesthesia medications, antibiotics, and pain medications and expects to deliver these products this year. Best case scenario is that we surpass these expectations. We have enlisted the support of a Drug Selection Advisory Committee, which includes health system pharmacy experts, to prioritize the medicines we make and the order in which we make them. So far, the Committee’s input has reflected incredible alignment on the most urgent medication needs.
From a manufacturing perspective, we are pursuing three approaches simultaneously. These include:
- working with multiple generic drug manufacturers that have US FDA approved manufacturing facilities and the capacity to produce Civica Rx labeled generic drugs
- developing or acquiring Abbreviated New Drug Applications (ANDAs) and working with contract manufacturers
- buying or building Civica Rx manufacturing facilities
Collaboration Is in the Best Interest of Patients
Multiple market dynamics driving generic drug prices to “race to the bottom” or leading to “predatory” pricing have gotten us to this point of a need for disruption and sustainable solutions. The reality is, no one entity has caused the drug shortage problem and no one entity will fix it. With its member-driven approach and pro-competition philosophy, Civica’s business model is all about collaboration and we invite opportunities to innovate in ways we haven’t yet considered.
It has been an exciting beginning for Civica Rx, thanks to all of those who have become central to our mission on behalf of hospital patients across the country. These include the creator of the Civica Rx concept, Dan Liljenquist, SVP and chief strategy officer at Intermountain Healthcare, our hospital system members, our philanthropy partners, our potential supplier partners, and our newly established management team. These leaders bring experience in drug development, manufacturing, quality/regulatory compliance, and all aspects of pharmaceutical operations necessary in assuring the availability, quality and affordability of generic medicines. I am honored to work alongside each one of them and thank them for their steadfast commitment to improving patient care.
As we look ahead to the next six months of Civica and beyond, we know that serving patients is a privilege and one that comes with great responsibility. We will know we have succeeded in our mission-driven venture when our results include:
- a robust supply chain for important medications, including older drugs
- protection from predatory pricing
- long-term certainty for manufacturers so that they can invest in their manufacturing plants and prevent future drug shortages
The most important result will be that essential generic medications are available to patients when they need them. Civica exists for one reason and that is to do what is in the best interest of patients by delivering quality medicines in a reliable manner at fair and sustainable prices.