This project has been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (DHHS). The total contract value awarded to Phlow is up to $812 million which includes a four-year base award of $354 million with an additional $458 million included as potential options for long-term sustainability.
Phlow has also said it is building the United States' first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines on U.S. soil, reducing America's dependency on foreign nations to support its drug supply chain.
"Years from now, historians will see this innovative project as a defining moment and inflection point for protecting American families‑—and our country—from current and future public health threats," said Peter Navarro, director of the White House Office of Trade and Manufacturing Policy. "For far too long, we've relied on foreign manufacturing and supply chains for our most important medicines and active pharmaceutical ingredients while placing America's health, safety, and national security at grave risk. We are now moving swiftly in Trump time to forge an American solution, one that leads with American ingenuity, American workers, and American factories all dedicated to ending our drug shortages and expanding drug manufacturing infrastructure for a healthy and secure future."
With its partners, Civica Rx, Virginia Commonwealth University's Medicines for All Institute, and AMPAC Fine Chemicals, Phlow has initiated manufacturing chemical precursor ingredients, active pharmaceutical ingredients (APIs), and finished dosage forms for over a dozen essential medicines to treat hospitalized patients with COVID-19-related illnesses. Many of these medicines are in shortage and have previously been imported from foreign nations.
The partnership with HHS/ASPR/BARDA immediately enabled Phlow, with the help of its partners, to deliver over 1.6 million doses of five essential generic medicines used to treat COVID-19 patients to the U.S. Strategic National Stockpile (SNS), including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.
"BARDA has long focused on expanding pharmaceutical manufacturing infrastructure in the U.S., not only to develop and produce vaccines, but also for essential medicines, and their key ingredients used to make these drugs," said BARDA Acting Director, Dr. Gary Disbrow. "Collaborating with Phlow and its partners is an important step in expanding our manufacturing of strategic APIs and critical medicines at-risk of shortage."
The threat of pandemics like COVID-19 has exposed the United States' heavy reliance on foreign pharmaceutical supply chains. Over 80 percent of APIs and chemical ingredients used in the U.S. to manufacture generics and over-the-counter drugs are produced abroad, the majority coming from China and India.
"In the midst of this pandemic, America needs a reliable source of high quality, domestically manufactured, affordable pharmaceuticals and their key ingredients," said Eric Edwards, MD, PhD, co-founder, president and CEO, Phlow. "This advanced manufacturing capability will significantly fortify our nation's pharmaceutical supply chain for critical medicines, including many required to treat patients hospitalized with COVID-19."
Over the past twenty years, due to economic and regulatory factors among others, manufacturing of active pharmaceutical ingredients and essential generic medicines in the U.S. sharply declined. This collaboration with United States Government provides security and sustainability to the nation's drug supply chain, enabling the U.S. to create a solution to combat the nation's chronic issue with generic drug shortages.