U.S. Pharmacopeia (USP): Science and Resilience in the Face of Global Turbulence

As Donald Trump's policies and proposed tariffs make headlines in the United States, healthcare scientists and academics there keep their eyes on the horizon, seeking to collaborate across borders and ensuring that quality medicines remain a cornerstone of global health—for all people on the planet.

The United States Pharmacopeia (USP) convention brought together hundreds of representatives from across the U.S. healthcare and science ecosystem from May 5-8, 2025, who are undistracted by the noise of geopolitical disruptions, health crises, and protectionist debates. Among the key issues highlighted for the immediate future are: mitigating the risk of shortages, maintaining drug quality, optimizing prices, promoting biosimilar drugs, and expanding digitalization.

The event hosted a dialogue between academic institutions, manufacturers' associations, government agencies, NGOs, patient organizations, and healthcare professionals, seeking to chart a path toward a more resilient, sustainable, and equitable global supply of medicines, something that should be of great interest to Mexico as a trading partner and neighboring country. Among what is noteworthy is that the US Pharmacopeia is currently seeking to expand its presence internationally. Representatives from Mexico were present at the aforementioned event, including authorities from Cofepris—specifically, Commissioner Esther Ruiz, of Evidence and Risk Management—as well as members of the industry, particularly from the Mexican Association of Pharmaceutical Laboratories (AMELAF), with its executive director, Juan de Villafranca, who has maintained a very active relationship for three years with USP, whose CEO, Ronald Piervincenzi, is clearly interested in opening the pharmacopeia to countries in the region. Also present were Brazil, Colombia, Argentina, and Peru.

The priorities identified by USP in its 2020-2025 strategic cycle transcend political circumstances and focus on long-term structural challenges, including:

*Multilateral collaboration: USP's success lies in its global network of regulators, industry, donors and NGOs.

*Structural reform versus protectionism: Although the debate over local production in the U.S. is gaining momentum, USP sees an opportunity to discuss the geographic concentration of manufacturing and the lack of resilience in essential generics, promoting incentives that guarantee stability.

*Strengthening resilience: It's not just about resisting crises, but also about building robust supply chains. Tools like the Medicine Supply Map allow for real-time risk mapping, helping manufacturers and distributors anticipate shortages and diversify suppliers. "Avoid overdependence on one region or supplier, as seen during the COVID-19 pandemic."

*Stabilization of the generic drug market: The generic drug price crisis has affected accessibility. USP advocates for policies that promote redundancy, quality, and early warning systems, as well as incentives for reliable production.

*Scientific modernization and global standards: USP has responded to challenges such as the pandemic, the nitrosamine crisis (potentially carcinogenic compounds in some medications, raising concerns and requiring changes in manufacturing processes), and new healthcare challenges with standards developed in record time. Its modernized laboratories and leadership in advanced therapies (gene therapy, biosimilars) and green chemistry consolidate its role in more than 155 countries.

*Strengthening global capacities: Through partnerships with USAID, Unitaid (a global health agency sponsored by the WHO that seeks to innovate and accelerate access to treatments, diagnostics, and healthcare tools for low- and middle-income countries), and regulators, USP has trained more than 100,000 scientists and supported localized manufacturing projects in Africa, promoting self-sufficiency in vulnerable regions.

*Digitalization and Manufacturing 4.0: The adoption of modern technologies and digitalized processes has allowed USP to achieve operational agility.

*Patient engagement and advocacy: USP recognizes the voice of patients as essential to closing gaps with the industry and reforming purchasing policies that prioritize resilience over price.

USP's message was clear: the future is not built on protectionism, but on collaboration, agility, and a collective commitment to resilience.

Amelaf: Its proximity to USP opens doors for Mexican pharmaceutical companies in the US

Interviewed at the USP Convention, Juan de Villafranca, from Amelaf, highlighted the virtue of the USP in being one of the few pharmacopoeias that are independent of the regulatory agency, although it works jointly with the FDA, and also that its structure has been building strength beyond the US borders, such as the one in Mexico, where it has been working for three years, which helps to further promote ties between the regulatory agencies of both countries.