By Samantha Cart
The COVID-19 pandemic forced ordinary Americans—not just economists, manufacturers and businesspeople—to consider and confront the country’s supply chains. Even now, two years after the onset of the pandemic, walking the aisles of a supermarket can reveal bare shelves and empty spaces where certain products should be. As a result, more and more people want to know where their merchandise comes from.
In December 2021, the U.S. Food and Drug Administration (FDA) announced that 111 drugs were on backorder, including some heart medications, antibiotics and cancer medications. While some of those issues have since been resolved, the FDA’s Center for Drug Evaluation and Research subsequently asked manufacturers to evaluate their entire supply chains.
According to Dr. William Petros, professor of pharmaceutical sciences, Gates Wigner Endowed Chair and dean of the West Virginia University (WVU) School of Pharmacy, experts have been discussing the hazards of the offshore manufacturing of pharmaceuticals for several years.
“If I go buy a shirt, I can look on the tag and see where it is made. You know where your food is made, you know where your clothes are made, but you don’t know where your pharmaceuticals are made,” he says.
Petros says even pharmacists have a hard time finding this information. Containers of drugs delivered to a pharmacy are distributed from a certain company, but this company may have plants in multiple countries.
When taking a pill or tablet, what is ingested is not all drug. There are usually around 10 other ingredients in it to help it dissolve in the body, among other things. The active pharmaceutical ingredient (API) combined with these additional ingredients creates the final dosage product.
“Here are the hard facts: approximately 90% of our generic drugs and about half or more of our brand name drugs are made, at least in part, overseas, and 90% of the API in the world is made in China right now,” he says. “You can just imagine if we ever went to war with China or China shut down for some reason—the world would be in trouble.”
These facts have forced Americans, including many West Virginians, to consider what would happen if they no longer had access to their daily blood pressure, cholesterol, diabetes or other chronic condition medications. In a state with a prevalence of poor health diagnoses, including the highest overall cardiovascular disease prevalence in the nation, this information elicits questions such as: Do medications produced in India and China present a greater risk to U.S. patients? Does our reliance on foreign suppliers put us at risk for lower quality medications or an overall shortage of these medications? What can we do to ensure access to safe, domestically manufactured pharmaceuticals?
“As we experienced the COVID-19 pandemic, we saw that a lot of supply chains were quite disrupted because of our reliance on other countries, whether it was China, India or Italy,” says Clay Marsh, M.D., vice president and executive dean for health sciences at WVU and West Virginia’s coronavirus czar. “When they got in trouble as countries and started having surges, they not only produced less, but they were also using more of those materials for their own population and weren’t able to meet some of the supply chain needs of other countries. That is going to be part of our understanding as far as assessing our own vulnerabilities that COVID-19 has exposed to us. That is something we need to change in the future so we are much more self-reliant.”
How Did We Get Here?
In the U.S., most of the medications people take are generic, and generic drugs also make up the majority of those in short supply.
“Why are we in this quandary? In my mind, the main reason we’re here is because generic drugs have become a commodity—they are too cheap,” says Petros. “Because they’re so cheap, people can’t make a lot of money off of them, and you end up with limited manufacturers in the world and production is pushed to the place where they can be made the cheapest.”
For example, sodium phosphate is commonly used in hospitals and is currently in short supply. While it only costs pennies to make, there are limited companies that manufacture it.
“I know it sounds ludicrous to say generic drugs cost too little,” says Petros. “Approximately 90% of prescriptions in the U.S. are for generic drugs, but generic drugs only make up 23% of our total drug spend in the U.S.”
At one point in time, Mylan Pharmaceuticals in Morgantown, WV, was one of the largest manufacturers of generic drugs in the world, producing approximately 18 billion doses of medicine each year.
“For years, Mylan saved this country and patients trillions of dollars,” says Petros.
In 2019, after nearly 60 years as a West Virginia and Pennsylvania company, Mylan merged with a division of Pfizer Inc. to became Viatris. Viatris serves more than 165 markets around the world and has three global centers located in Pittsburgh, PA; Shanghai, China; and Hyderabad, India.
Are We at Risk?
“We have become too reliant on supply chains outside our own control, whether it is therapeutic drugs or steel or computer chips, and it happened because everybody wanted the lowest price possible,” says Major General James Hoyer, USA, retired, and vice president of economic innovation at WVU. “That put us, in my opinion, in a very vulnerable national security position.”
While this is cause for concern, Hoyer believes the U.S. can take advantage of this knowledge and create many jobs in the process.
“How do we become part of the solution set? How can we use applied research and knowledge so when the next virus or bug comes, there has already been some modeling done that looks at how, in 90 days or less, we could roll out something?” he says. “I think the applied capability to do that is there, but you also need the manufacturing piece. We must look at it from a national perspective. In the National Guard, I always said our job was to turn challenges into opportunities. This is clearly
a national security challenge that we ought to turn into an opportunity going forward. The will is there, but it is going to take policy, political will and private capital investment to turn it around—and we have to do it pretty quickly.”
According to Marsh, the U.S. needs a foundation of its own production and manufacturing capabilities to rely on in times of crisis.
“In times of tremendous stress, these channels can fracture, and these will be part of our national security and crisis response requirements in the future,” he says. “As part of our state leadership, we talk about the reagents we need to be able to save lives and protect hospital capacity here in West Virginia, and one of the reagents that is now in shorter and shorter supply is monoclonal antibodies. We are seeing a reduction in the availability of this vital supply. From a human health and well-being perspective and from our hospital system’s capacity perspective, we need to have access to critical factors, whether it is drugs, intravenous solutions, durable equipment, personal protective equipment, ventilators or oxygen.”
How Do We Move Forward?
In early 2021, the Made in America Act was proposed in Congress to create tax incentives to bring pharmaceutical manufacturing back to the U.S. The bill is currently under the review of the Subcommittee on Commodity Exchanges, Energy and Credit. Only time will tell whether government or private entities will take up the mantle—and the opportunity—of manufacturing pharmaceuticals on U.S. soil.
“When we debrief and do the autopsy on COVID-19, this is going to be important because as we rely on other countries for our supply chain, distribution channels and critical materials, we see the vulnerability we have in the U.S. I think it’s a wakeup call for us,” says Marsh.
