Valisure, a trailblazer in technological advancements, and Picket Pharmaceuticals, a firm tackling the ongoing challenges of drug shortages and supply chain risks for crucial pharmaceuticals in the U.S., have unveiled a strategic partnership. This collaboration will integrate Valisure’s independent chemical analysis and certification program into Picket Pharmaceuticals’ portfolio of injectable drug offerings, aiming to mitigate the primary market failure of generic medications, characterized by insufficient quality transparency and precipitous pricing declines, which have contributed to unprecedented drug shortages in the United States.
Ongoing public health threats from significant drug shortages largely stem from quality issues, identified as the top cause of shortages. Based on FDA data regarding drug shortages with known causes, 76% of these shortages were linked to manufacturer quality problems in the period leading up to the Covid-19 pandemic, and recent analyses confirm this as a continuing major issue. Moreover, the U.S. witnesses roughly three daily drug recalls, frequently prompted by hazardous impurities.
“Implementing independent testing and ensuring transparency in the supply chain are crucial measures to safeguard the safety and effectiveness of medications. These elements have been increasingly recognized as critical gaps in the generic drug sector, ultimately leading to quality challenges and shortages,” expressed David Light, co-founder and president of Valisure. “We are thrilled to partner with Picket Pharmaceuticals in bolstering supply chain transparency and quality at this critical juncture.”
Valisure and Picket Pharmaceuticals realized their shared vision through their participation in the End Drug Shortages Alliance (EDSA). The urgency within EDSA to not only comprehend the underlying issues causing drug shortages but to take tangible steps to prevent them and enhance the pharmaceutical supply chain spurred the creation of an innovative partnership between Valisure and Picket Pharmaceuticals, aiming to establish industry-leading models for transparency and quality. Particularly with medicines facing shortages, where purchasers are pressured to swiftly approve new supply sources, an added and visible assurance of quality profoundly benefits clinical teams, hospitals, pharmacists, and the patients they serve.
“Having observed Valisure’s successful independent quality assurance for solid oral medications, we recognized the necessity to extend this critical capability to injectable drugs, particularly due to the severe nature of drug shortages and supply chain issues in this sector,” mentioned Joshua Kriger, founder and CEO of Picket Pharmaceuticals. “I am impressed by the seamless incorporation of independent testing into our current quality manufacturing framework; collaborating with Valisure became an obvious choice to transparently highlight Picket’s dedication to the utmost quality of our products and processes.”
Through this partnership, Valisure’s independent certification program will offer Picket Pharmaceuticals’ clients essential transparency regarding the chemical quality of their products. This initiative underscores both companies’ dedication to addressing systemic issues within the pharmaceutical supply chain and advocating for quality as a core consideration in medicine sourcing and distribution.
Valisure stands as a pioneering technology entity committed to bridging a critical void in the healthcare supply chain via independent quality assurance.
Picket Pharmaceuticals is devoted to tackling persistent drug shortages and supply chain risks for essential medicines in the U.S. Employing various models, Picket supports the natural alignment of existing stakeholders, each possessing unique operational and regulatory demands.