THE COVID-19 crisis has illuminated a scary truth: many of the active pharmaceutical ingredients (API) needed for medications to treat patients with coronavirus and many other serious diseases in the United States are imported from overseas—where manufacturing costs are much cheaper. But when there’s conflict or a worldwide demand for certain drugs as there has been during this pandemic, this supply chain is less than reliable.
Last December, even before COVID-19 hit the U.S., Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, testified before the House Subcommittee on Oversight and Investigations that just 28 percent of APIs were manufactured in the U.S. Although nearly half (47 percent) of prescription drugs are finished here, drug companies have to import more than 70 percent of the raw materials they need.
The FDA stepped up its foreign inspection program in 2006, and since 2015, the agency has conducted more foreign inspections of drug manufacturing plants than domestic ones. However, Dr. Woodcock noted that “under our current authorities, foreign-based manufacturers of certain drugs can legally ship drugs to the United States without ever having been inspected by FDA. Drugs in this category typically include over-the-counter monograph drugs and APIs used in pharmacy compounding. This increases the risk of exposing American patients to unsafe or ineffective drugs and requires resource-intensive efforts on FDA’s part to identify and respond to any problems that arise subsequently.”
That’s precisely why the April announcement that Phlow, a Richmond-based pharmaceutical company, received a $354 million federal contract from the U.S. Department of Health and Human Services to manufacture key pharmaceuticals in Virginia was such welcome news. The federal funds enabled the company 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, including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain essential antibiotics.”
The reality that doctors and hospitals in the U.S. might not be able to obtain such needed drugs during the next medical or geopolitical crisis is frightening. The fact that Phlow will start producing a secure and reliable source of APIs and high-quality, low-cost generic drugs here in Virginia is reassuring. Better yet, the medicine will be manufactured in Petersburg, employing about 350 Virginians in a city that needs the jobs.
The company says it plans to use “continuous manufacturing” to produce finished drugs, which is faster, more efficient, and more likely to reduce human error than the more commonly used “batch manufacturing” process. The new technique also makes it easier to respond to market changes, such as when demand surges during a pandemic.
Phlow was co-founded by Dr. Eric Edwards, a pharmaceutical executive and entrepreneur who graduated from the Medical College of Virginia, and Dr. Frank Gupton, a professor in Virginia Commonwealth University’s Department of Chemical and Life Science Engineering. “In the midst of this pandemic, America needs a reliable source of high quality, domestically manufactured, affordable pharmaceuticals and their key ingredients,” Dr. Edwards said. And the commonwealth is ideally suited for such a venture.
President Trump has vowed to bring critical supply chains back to the U.S. to ease the nation’s dependence on other countries, particularly China. The Phlow contract is a good place to start. “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.
Sen. Mark Warner agreed. “Virginia will be better equipped to lead the production of these vital medical resources here in the U.S.,” he said, noting that he has also raised concerns about the nation’s dependence on Chinese drug imports.
The entire world has benefited from robust trade with other countries. But pharmaceuticals and military equipment needed for our national defense are two categories that should always be marked “Made in the USA.”