Issue link: https://www.e-digitaleditions.com/i/1112785
Chronic generic drug shortages have been a problem in the US for more than a decade, and more than 200 drugs have been on and off the FDA's shortage list in recent years. The stories about how these short- ages impact patients are profoundly moving. Hospitals are forced to delay surgeries or offer sub-optimal treat- ments. Hospital staffers hold weekly, or sometimes daily, huddles to triage alternative drug solutions for patients rather than using that time to provide excellent patient care. Patients ration their own medicines. And physicians must tell patients that they have a devastating illness but that the best treatment option is not available due to a drug shortage. Disrupting the generic drug marketplace In May 2019, Civica Rx was launched with a brand-new strategy to influence and help improve the generic drug marketplace. Civica Rx exists in the public interest as a non- stock, non-profit corporation to address shortages of generic drugs while lowering their costs. The com- pany 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 Rx's board of directors [1]. In recent months, nearly 20 more health systems have joined Civica Rx as "founding" and "partnering" mem- bers [2,3]. In all, Civica Rx's mem- bership includes more than 800 hos- pitals 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 hos- pital size, and a membership struc- ture that is open to all. We are pro-competitive and committed to eliminating uncertainty in the generic drug supply chain, in part by entering into long-term contracts with both our health-system partners and with 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. Initially, Civica Rx will focus on providing 14 much-needed medica- tions, primarily sterile injectables such as anesthesia, antibiotic, and pain medications. We expect to begin delivering these products this year. A best-case scenario would be that we surpass our expectations and deliver more than the initial 14 med- ications this year. We've enlisted the support of a drug-selection advisory committee comprised of health-sys- tem 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 with the most urgent medication needs. From a manufacturing perspec- tive, Civica Rx is simultaneously pur- suing three approaches: • working with multiple generic drug manufacturers that have US FDA-approved manufacturing facili- ties and the capacity to produce Civica Rx-labeled generic drugs; • developing or acquiring abbre- v i a t e d n e w d r u g a p p l i c a t i o n s (ANDAs) and working with contract manufacturers; and • buying or building Civica Rx manufacturing facilities. Collaborating to serve the best interests of patients Multiple market dynamics driving generic drug prices to "race to the bottom" in some instances or result- ing in "predatory" pricing in others have led the pharmaceutical industry to a point where it needs disruption and new, sustainable solutions. No single entity has caused the drug shortage problem, and no single entity will fix it. With our mem- ber-driven approach and pro-compe- tition philosophy, Civica Rx is all about collaboration, and we invite opportunities to innovate in ways we haven't yet considered. Serving patients is a privilege that comes with great responsibility. As we finish our first year and look ahead to the future, we'll know we've succeeded in our mission if our results include: • a robust supply chain for important medications, including older drugs; • protection from predatory pric- ing; and • long-term certainty for manu- facturers, so 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 Rx exists for one reason: to serve the best interests of patients by delivering quality medi- cines in a reliable manner at fair and sustainable prices. T&C References 1. https://tinyurl.com/civica-govs. 2. https://tinyurl.com/civica-found. 3. https://tinyurl.com/civica-part. Martin VanTrieste is president and CEO of Civica Rx (800 242 4677, www. civicarx.org). He recently retired as senior VP of quality at Amgen and was chair of the Parenteral Drug Association board of directors. VanTrieste also founded the non- profit international supply-chain organi- zation Rx-360. b a c k p a g e Civica Rx: A disruptive solution for generic drug shortages