In a time of both opportunity and uncertainty across the pharmaceutical landscape, I had the opportunity to join John Murphy, President & CEO of the Association for Accessible Medicines (AAM), for a fireside chat where discussed a variety of issues facing the generic and biosimilars industries while emphasizing the importance of continued collaboration between USP, AAM, and FDA to solve these challenges.
Generic medicines account for over 90% of prescriptions filled in the U.S., providing critical savings throughout the healthcare system, while continuing to improve access and affordability for patients at the point of care. But the system that supports them is under pressure. Market dynamics, pricing models, and supply chain vulnerabilities challenge manufacturers’ ability to deliver, adding complexity and creating uncertainty. These pressures demand bold, coordinated action, because the stakes for patients are too high to ignore.
At USP, we’re leading efforts to help manufacturers navigate this complexity and deliver quality medicines. We’re working with industry and regulators to make that happen through early engagement, transparency, and collaboration:
Early engagement on standards
USP is releasing over 100 new monographs this year. Our now-public Small Molecules Pipeline offers visibility into emerging standards, enabling manufacturers to engage early and help define global benchmarks for medicine quality. We’re inviting AAM members to contribute insights, materials, and scientific expertise to shape standards that reflect real-world manufacturing realities.
Ongoing collaboration with FDA
USP works closely with FDA to align regulatory thinking with the standards we develop. FDA now encourages companies in ANDA and NDA Approval letters to engage with USP, reinforcing the role of public standards in streamlining regulatory pathways.
Addressing emerging quality challenges
USP is evolving its scientific work to help manufacturers and regulators manage new risks across the product lifecycle. We're focusing on complex generics, monoclonal antibodies (mAbs), microbial contamination control, extractables and leachables (E&L), polymeric and phospholipid excipients, and nitrosamines — all areas where quality concerns can delay access and impact patient safety.
Strengthening supply chain resilience
When we talk about the medical supply chain, we’re really referring to a thousand supply chains – each working to develop one of the many treatments that patients rely on. That results in an incredibly complex system that needs visibility and predictability to avoid disruptions. USP’s Medicine Supply Map, now expanded to include Key Starting Materials, provides manufacturers and policymakers with critical insights into supply chain vulnerabilities, helping guide investment and policy decisions.
Introducing the Drug Supply Chain Resilience Initiative
This new USP initiative is working with manufacturers and purchasers to develop criteria to assess resilience and reliability across the supply chain. By valuing resilience in purchasing decisions, we can help stabilize the generic market and ensure continued access for patients.
I want to thank AAM and its members for their enduring commitment to drive access to affordable, quality medicines. USP is committed to working hand-in-hand with AAM, FDA, and industry leaders to strengthen the pharmaceutical landscape through collaboration, transparency, and a shared focus on quality. Together, we will uphold the promise of generics—ensuring every patient receives the medicines they need, when they need them.
