The United States Pharmacopeia: 200 Years of Building Trust in Medicine

The TEDMED 2020 theme is Make Way For Wonder, and we are looking forward to convening our Community and embracing the wonders of our times, the astonishing accomplishments, incredible possibilities, and extraordinary potential for the future. So, we were thrilled when the United States Pharmacopeia (USP) decided to celebrate its 200th Anniversary with TEDMED. After all, today’s wonders are built upon a strong foundation of scientific discovery. And, humanity is especially eager for those innovations that will help people everywhere live longer and healthier lives. In anticipation of USP’s presence at TEDMED in March, we talked with Ronald T. Piervincenzi, Ph.D., chief executive officer, about the organization’s history, its current work, and its approach to building trust in the future of medicine, supplements, and foods.

TEDMED: We’re excited to have you and USP join the TEDMED Community, especially on the occasion of such a monumental milestone – USP’s 200th anniversary.

Ronald T. Piervincenzi: Thank you. I’m thrilled to introduce USP to TEDMED’s audience and look forward to meeting attendees in Boston in March.

TM: What made you choose TEDMED to celebrate this milestone anniversary?

RP: Today, we are observing an unprecedented transformation in healthcare. USP’s 200-year legacy is built on trust and confidence in healthcare systems and anticipating and responding to emerging health challenges. Our founders joined together in 1820 to protect patients from a prevalence of poor-quality medical products. The backdrop today is different in scale, geography, modalities and many other factors. But the value of our work is the same. We are exploring how to build trust in future medical breakthroughs. There are many in the TEDMED community we can learn from and engage with as we imagine what the future holds.

TM: That’s exactly what TEDMED is all about! Let’s dive in. What is a pharmacopeia and what does USP do?

RP: Simply put a pharmacopeia is an official publication that includes a list of medicinal drugs and contains how those medicines are to be prepared, directions for their use, and assays to assess medicinal quality. The United States Pharmacopeia–National Formulary, which USP publishes, is the official quality standard for medicines marketed in the U.S. It is also used in over 140 other countries. USP is the leading independent scientific nonprofit organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and capability building, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. As the world gets smaller and more connected, quality issues affect everyone. Diseases travel. Drug resistance grows. Fake medicines kill. The foundation of quality we’re building helps address these and other global health challenges. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we’re there across 10 global sites working to protect the health of people all over the world.

TM: This seems like a very modern approach to medicine. Why did the U.S. need a pharmacopeia in 1820?

RP: Today, people trust U.S. medicines to be among the safest in the world but that wasn’t always true. In 1820, the U.S. was a new country. Medicines were made individually and differently by physicians or apothecaries. There were no regulations or more importantly, standards, to ensure that what you received in one city was the same as another. A medicine’s strength, quality, and even its identity varied widely depending on where it was made. Simply put, before our founding in 1820, there was no way to ensure that what was on the medicine label was what was actually in the bottle. Our founders—11 independent, forward-looking physicians— were concerned about this lack of uniformity and acted to protect patients from poor-quality medicines. Three of our founders were not only physicians, but also U.S. Senators—they were the voice that the U.S. needed to ensure the quality of medicines Americans used. They established the U.S. Pharmacopeial Convention, which published the first U.S. Pharmacopeia. A great deal has changed since our founding but the importance of having quality standards for medicines and other new therapies remains—now, our work is much more global.

Image courtesy of USP

TM: This year’s TEDMED theme, “Make Way for Wonder,” explores how medicine and healthcare is changing. Is that a theme that resonates with you?

RP: Absolutely. Wonder and scientific discovery makes medical breakthroughs possible. But trust makes them popular. More than 800 independent volunteer scientists contribute their expertise to develop and approve USP’s standards. They help to build trust by setting clear quality expectations for medicines, dietary supplements, and foods. In turn, USP standards help manufacturers worldwide bring more quality and affordable products to market, which benefits people everywhere. A recent Johns Hopkins University study found that on average, drugs with a USP public quality standard had approximately 50% more generic manufacturers compared with medicines without such a standard. The study also found that quality standards helped facilitate pharmaceutical competition and reduce prescription drug costs in the U.S.

Image courtesy of USP

TM: How does a 200-year-old organization prepare for the future?

RP: New technologies and treatments—precision medicine, digital therapeutics, 3D printing, immunotherapy, gene and stem cell therapies, and artificial intelligence—have arrived or are on their way. As we prepare for dramatic breakthroughs, we must work to ensure trust and quality are established as a part of these advances. Unfortunately, trust broadly is in a precarious position across sectors. Our history has taught us that for an innovation to become a widespread reality, both quality and trust are critical to its broad acceptance. USP together with hundreds of our stakeholder organizations and partners are already working to build confidence in future breakthroughs and to anticipate and address where the gaps will be. We know that when a USP public standard is available, we help manufacturers be better able to adopt the new technology, which is often a significant cost savings. In addition to conducting workshops and roundtables on topics such as cell and gene therapies and digital therapeutics, USP is working with the MIT Center for Collective Intelligence and more than 100 leaders from health and science worldwide to explore the developments and role that trust will play in shaping people’s health between now and 2040. We will explore the project’s findings from this “Trust CoLab” with the TEDMED 2020 Community.

Image courtesy of USP

TM: We’ll look forward to learning more about the Trust CoLab. Until then, what else should the TEDMED Community know about USP?

RP: I mentioned our volunteer scientists earlier. I invite TEDMED community members who are committed to making the world healthier, being scientifically rigorous, and working independently from politics or the private sector, to consider becoming a Champion of Trust. They can learn more by visiting our website or by stopping by the USP Lounge in the Social Hub at TEDMED. I also encourage everyone to also learn more about USP’s past, present and future and opportunities for other collaborations with us at www.usp.org/200.

TM: Thank you, Ron and very best wishes on the beginning of USP’s third century.