HHS Takes Action to Make the U.S. the Most Competitive Nation in the World for Pharmaceutical Manufacturing
Senior leaders from the U.S. Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR) today visited On Demand Pharmaceuticals' (ODP) new Centralized Production and Repackaging (CPR) manufacturing facility in Rockville, MD, and virtually toured ODP's Pharmacy on Demand (PoD) modular manufacturing unit. ODP's CPR plant produces active pharmaceutical ingredients (APIs) for medicines of critical importance to the U.S. health system. The PoD is a modular manufacturing platform (that can be as small as the size of a tractor trailer) that leverages the latest AI and machine learning techniques and can be quickly customized to produce any finished dosage form (FDF) whenever and wherever needed. The PoD is currently deployed to Northern Mississippi Medical Center to produce medicines that are in shortage in real-time.
Under the U.S. Department of Defense (DoD) and ASPR-funded effort, ODP is building out its domestic capability to manufacture APIs and FDFs using a game-changing, manufacturing technology platform that will enable the production and distribution of critical medicines at the point of care, such as a hospital or clinic that is facing drug shortages, or after a disaster or public health emergency. ODP's distributed manufacturing network – from chemical synthesis to drug formulation to finished product – will save time, money, and overcome many supply chain challenges in the United States.
"This collaboration not only underscores the strategic importance of bolstering domestic production of finished drugs but also sets the stage for transforming how medicines are made and delivered in this great country of ours," said ASPR Principal Deputy Assistant Secretary John Knox. "Having the added flexibility and capability to deploy a network of modular, medicine production facilities to produce drugs wherever needed is key to mitigating drug shortages and supporting disaster operations, especially when responding to unexpected disease outbreak or to hurricanes, wildfires, or other natural disasters that often disrupt regular distribution channels or cause sudden shutdowns to pharmaceutical manufacturing plants"
Today's visit is part of the ongoing collaboration between HHS-ASPR, DoD, and ODP that began in September 2020, as part of the first Trump Administration's efforts to reshore America's pharmaceutical supply chain and reduce dependency on foreign countries. This effort also aligns with the current Trump Administration's executive order Regulatory Relief to Promote Domestic Production of Critical Medicines.
Funding to support ODP's Pharmacy on Demand – which is just one part of more than $1 billion HHS has invested in domestic manufacturing of APIs and FDPs – will help patients get more reliable access to the quality medications they need. The investments also fulfill a promise President Trump made to the American people: to build advanced manufacturing technologies that address shortages of medicines, speed time to market, and "make the United States the most competitive nation in the world for the manufacture of safe and effective pharmaceutical products."
