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In the second of a two-part series, leaders of industry associations present their expectations for pharmacy operators for this year.
The past year was significant for the pharmaceutical industry, as we witnessed major milestones and celebrated advancements in innovation. We saw an official end to the COVID-19 pandemic public health emergency and unlocked the potential of mRNA technology in treating diseases and viruses. At the same time, gaps in the global pharmaceutical supply chain became more pronounced, as we experienced ongoing shortages of over 300 drugs in the United States, with cancer patients struggling to get life-saving medicines and parents finding it difficult to find antibiotics and asthma medications for their children.
Ronald Piervincenzi
The organization I lead, the U.S. Pharmacopeia (USP), represents leading independent scientific experts who volunteer their time to develop the quality standards and related programs that underpin the availability of safe, quality medicines around the world. Through this work and our collaboration with industry leaders, regulatory bodies and policy makers, we have a role in almost every stage of the medicine supply chain. Our work provides us with unique insights into what is happening across the pharmaceutical industry and what issues are top-of-mind for our key stakeholders. As we enter 2024, we see the biggest areas of focus centering on improved supply chain resilience, medicine quality and biomedical innovation in emerging medical fields.
Strengthening the medicine supply chain
Although the global medicines supply chain is stronger than other supply chains, such as for household products, it needs to be more resilient, as brought to focus during the COVID-19 pandemic. Industry leaders and policy makers are feeling the pressure to find ways to make the supply chain stronger to ensure patients can get the medicines they need when they need them.
In 2023, drug shortages were the highest they’ve been in decades, diminishing access to hundreds of different drugs in various therapeutic areas. More than 15 life-saving chemotherapy drugs, various ADHD medicines, and common antibiotics, such as amoxicillin, experienced shortages, creating serious health concerns for patients across the country and even globally. Given the severity of these drug shortages — some of which have forced health care practitioners to make difficult decisions in prioritizing access to a limited supply of medicines — the lack of transparency due to insufficient access to information has become apparent. Continued, proactive data and information sharing among industry professionals, policy makers and government officials is necessary to mitigate ongoing and future shortages.
At USP, we monitor the medicine supply chain through tools like the USP Medicine Supply Map (MSM) to analyze vulnerabilities and identify risks for drug shortages. We use these insights to help inform industry and policy makers and advocate for action that will create a more resilient supply chain, including increasing manufacturing and promoting geographic diversity, identifying alternative suppliers or medicines, or engaging suppliers outside of the U.S. — thus increasing transparency in the pharmaceutical industry and strengthening public health and safety.
Biomedical innovation
Over the past year, we’ve continued to expand our understanding of biomedical innovation, with life-saving and life-altering medications delivered at a scale and speed unlike anything seen before. The development of novel and cutting-edge advancements in biologic medicine will increasingly become a global priority tied to access and equity, challenging us all to think critically, practically and ambitiously about the future of health care.
Advancements in biologics are essential in the rapidly growing biomedical field. However, the complexity and biomanufacturing process of biologics can result in complications when it comes to maintaining quality across manufacturing and development. In response, quality assessment solutions are now available for companies to implement to ensure safety for biologic products.
Promising areas of growth within the field of biologics include advancements in monoclonal antibody (mAb) technology and biosimilars. The majority of research in novel biologics has been based in the U.S. and EU, given the complexity and quality characteristics of these molecules, but that may be changing. USP has developed quality assessment solutions that intend to help the industry overcome these challenges and support the advancement of mAb technology. Biosimilars also offer an exciting development in biomedical innovation, as they can be approved through an abbreviated regulatory pathway and have the potential to provide more cost-effective treatment choices for patients. These benefits hold great promise to help increase the availability of quality biologic medicines for myriad conditions, ranging from diabetes to cancer.
By developing solutions to foster the advancement of quality biologic technologies and products, USP and other industry leaders are dedicated to setting and following standards, reflecting the enthusiasm for future innovation, with quality assessment tools playing a pivotal role in advancing the biomedical industry with a focus on safety and quality.
Value of collaboration and transparency
As the unprecedented pace of transformative medicine continues to accelerate, key stakeholders and regulators in the pharmaceutical industry must work together to examine existing systems with a critical lens to leverage the tools at our disposal and protect public health, as well as identify gaps in quality and safety, creating new standards and solutions to address them.
The COVID-19 pandemic broke down barriers through industrywide collaboration to identify health care solutions and provide patients with adequate access to them. This trend has resulted in knowledge and data sharing that has accelerated solutions, helped avoid duplicative efforts, and instilled a spirit of partnership and discussion.
At USP, we recognize the need for open dialogue to successfully improve supply chain resilience on a global scale, establish stable access to drugs, and create an industry environment for collaboration across borders to ensure that safe medicines are available to patients, right when they need them.
As the industry evolves to adopt advanced biologic offerings, improved treatments and new products, we will continue to develop and provide robust standards that aim to ensure the quality of these therapies, regardless of their novelty. Together, through collaborative efforts that underscore the industry’s commitment to transparency and cooperation, we will continue to foster the advancement of quality solutions.
Ronald Piervincenzi is the CEO of U.S. Pharmacopeia (USP).
