This is a guest editorial by Ronald T. Piervincenzi, CEO of the US Pharmacopeia.
In 1820, eleven physicians took action to protect the people of their young nation from poor-quality medicines. These pioneers recognized that a lack of uniform standards for preparing medications put patient lives at risk. They founded the US Pharmacopeia (USP), and for 200 years, our organization has been setting official quality standards to build the public’s trust in medicines, dietary supplements, and foods.
I feel privileged to serve as USP’s CEO, particularly as we embark on our third century. In some ways, nothing has changed. We still work to help ensure patient safety. In other ways, everything has changed: the digitization of health care; new medicine modalities; a complex, globalized supply chain; and innovative manufacturing technologies. So what has contributed to USP’s resilience?
Core to our success are the organizations and individuals with whom we partner, including more than 460 USP convention member organizations, of which the American Chemical Society is one, and the more than 800 independent volunteer scientists who contribute their expertise to develop and approve the standards that build trust in the world’s medicines.
A willingness to embrace change is also crucial. Consider how USP has adapted to advances in chemistry over the years. The first United States Pharmacopeia, published in 1820, was essentially a collection of recipes and a list of materia medica used to prepare the most common medications of the day. That changed in 1880, when under the leadership of visionary chemist and pharmacist Charles Rice, the sixth version of the United States Pharmacopeia was transformed. It was no longer a recipe book but became a viable chemistry resource that included formulations and purity tests grounded in the latest principles of analytical chemistry.
Today, USP’s existing standards are in continuous review on the basis of new evidence and technologies, emerging public health priorities, and open requests for revision. We are also continually developing new standards and related educational programs driven by need and emerging pharmaceutical innovations. Two hundred years ago, our founders focused on ensuring the quality of US medicines. Over the decades, our reach has expanded. Now USP is a global enterprise, and over 150 countries use our public quality standards.
True to its mission of improving global health through public standards and related programs, USP helped safeguard the world’s pharmaceutical supply when the Food and Drug Administration began to recall angiotensin II receptor blockers because of the threat of nitrosamine impurities, including N-nitrosodimethylamine and N-nitrosodiethylamine, that may cause cancer. To tackle broader concerns about impurities, specifically in medicines under development, USP has instituted a service that identifies, isolates, synthesizes, and characterizes impurities with the combined goal of accelerating the development process and delivering quality medicines to market.
Given the current pace of innovation in science, I wonder whether USP’s forebears could have envisioned how the field of medicine would change in 200 years. Digital therapeutics, 3-D printing, immunotherapy, gene and stem cell therapies, precision medicine, and artificial intelligence—all have arrived or are on their way.
At USP, we believe trust and quality must remain at the heart of each advancement. That’s why, as part of our anniversary celebration, we have partnered with the Massachusetts Institute of Technology Center for Collective Intelligence in the development of an online platform, the Trust CoLab, that explores the developments that will shape people’s health between now and 2040 and seeks to understand how trust in medicine and health care will evolve during that time. Copies of a report on the findings will be available by email request at email@example.com.
Strengthened by our 200-year legacy, USP is poised to be at the forefront of innovations in medicine and to remain adaptable in delivering solutions that safeguard the quality of medicines around the world. USP will work to ensure tomorrow’s remarkable innovations can be trusted in the same way quality medicines have been trusted in the past 200 years.
Views expressed on this page are those of the author and not necessarily those of ACS or C&EN.