Will the Ministry of Defense have to start producing medicines to protect the troops?

Longstanding problems with drug shortages are pushing senators to seek more solutions for the military medical system, including the ability to have the military produce certain drugs.

Senators are calling for a return to drug production in the United States amid national security concerns about risks to the Defense Department’s pharmaceutical supply chain and potential risks to service members and their families.

But that also includes the possibility of some military production, said Sen. Elizabeth Warren, D-Mass., chair of the Senate Personnel Subcommittee, during an April 30 hearing.

“It is a critical national defense issue. It is also critical to the health of our people,” Warren said. One problem is that commercial manufacturers don’t have the right incentives to produce many drugs in the US

Furthermore, she said, “we don’t even have the right information to need meaningful domestic manufacturing and meaningful supply chain visibility to know if we are safe with the drugs we are getting,” and their ingredients.

Warren said she plans to introduce legislation that would direct the Defense Department to manufacture drugs, devices, vaccines and other products when the Defense Department determines there are risks of shortages or quality problems.

“Typically, DOD will continue to purchase drugs from the commercial drug market. But there are some cases where it makes sense for DOD to produce the drugs itself, such as when DOD is the only customer,” Warren said. According to her, DOD spends more than $5 billion per year on pharmaceutical products, which amounts to approximately 2% of the entire U.S. commercial pharmaceutical market.

A number of drugs used in the military are generally not needed in the commercial market, defense officials testified. Some of these are drugs needed to fight infectious diseases and are not commercially available because there is no market for them.

If production challenges are too great for smaller — but necessary — quantities of drugs, Warren said, the government may have to turn to military production. ‘Otherwise we just won’t get them. Or we pay prices that are so outrageous that it would have been cheaper to have built (the production facilities) in-house,” she said.

An example of this is the adenovirus vaccine. Although the adenovirus typically causes mild cold or flu-like symptoms, she said, “it is a leading cause of serious respiratory illness among military personnel, especially those undergoing basic training.” That’s why the Walter Reed Army Institute of Research developed the adenovirus vaccine and licensed it to private industry.

But in 1998-1999, the last supplies of the vaccine ran out after the sole manufacturer decided to stop using it. At the time, the Defense Department estimated that the lack of vaccine would lead to about 10,000 preventable adenovirus infections, more than 4,200 medical visits by recruits and more than 850 hospitalizations within a year, said Bryce HP Mendez, a defense health policy specialist. Congressional Research Service, testifying before the panel. “To some extent, Defense has observed that,” he said.

But that’s not unique, Mendez told lawmakers, adding that the Defense Department has had problems obtaining certain drugs for decades. Current challenges include production of drugs to tackle anthrax, botulism, cholera, hemorrhagic fever and others, he said.

Lawmakers should consider legislation that provides clear options for creating a government-owned facility to produce priority health products to meet the needs of the military, said Melissa Barber, an expert in pharmaceutical manufacturing and postdoctoral researcher at the Yale School of Medicine, Yale Law School. and Yale collaboration for strict regulation, integrity and transparency. “Such a facility would ensure reliable access to quality medications for service members and provide significant cost savings.” For example, she told lawmakers that the current contract to produce the adenovirus vaccine costs the government about $38 million a year. “That’s a lot of money to pay for one vaccine,” she said.

Barber cited an Army report that estimated the start-up costs for the government to manufacture the adenovirus vaccine would be about $100 million, with annual costs of about $10 million. DOD would break even in about three years by building and operating its own facility to produce that vaccine, she said.

Government-owned and operated facilities for drug production are not a new concept, Barber said. The first example she knows of, she said, is during the Civil War, when the U.S. military set up facilities to manufacture needed medicines.

The Walter Reed Army Institute of Research researches vaccines and produces test batches, but production is limited and the Army depends on commercial manufacturers for quantity.

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The bigger problem of drug shortages

According to the Food and Drug Administration, nearly half of the drugs on the DOD’s operational drug list are in short supply, and most of these are generics, Warren said. This list includes drugs needed for warfare, she said. Some of these are in short supply: the blood thinner heparin, the common anesthetic midazolam and morphine for pain relief.

And many drugs and their key ingredients come from foreign manufacturers, including China. The Ministry of Defense has less insight into its operations, and therefore into the safety of the drugs.

Following a congressionally mandated requirement, the DoD analyzed 12,917 specific drugs, or about 10% of the entire U.S. market, as part of efforts to evaluate the military pharmaceutical supply chain. The drugs are identified in the FDA Essential Medicine List. Only a quarter of the drugs analyzed have domestic manufacturers.

According to the November DOD report, 27% of drugs analyzed are at very high risk because they rely on Chinese manufacturers that use Chinese ingredients or come from unknown sources.

“I don’t know anyone in their right mind who would trust anything made in China,” said Sen. Rick Scott, R-Fla., the panel’s ranking member.

“During COVID, we have learned the hard way that relying on non-allied countries for our medical supply chain poses a real danger. For that reason, it is imperative that we ensure that Department of Defense supply chains are independent of non-allied countries for the necessary pharmaceutical treatments,” Scott said. “Under future circumstances, these supply chains could easily cease to exist.”

Defense officials are assessing the chain and developing policies and procedures to allow for the allocation of resources in the event of supply chain disruptions, said Dr. Lester Martinez-Lopez, assistant secretary of Defense for health affairs.

If a DOD supplier can’t get a critical drug due to the shortage, that supplier should look at alternatives, Martinez-Lopez said. He used the example of amoxicillin, an antibiotic made abroad and used for basic infections. ‘Let’s just say I don’t have it. Now I have to (use) a different antibiotic and at the same time I am trying to combat antibiotic resistance, with an antibiotic that is not indicated for that condition. So I lose there twice. Firstly, because I am not giving my patient the right antibiotic, but moreover, I am losing ground in my fight against antibiotic resistance.”

In other cases, such as when no epinephrine injection is available to treat a severe allergic reaction, he said, “that can be life or death. We don’t have hours to decide what the alternative is. So that could translate into a life, on site. So this creates a conundrum for all healthcare professionals. I don’t think it’s just us. It’s all over the country, we’re facing this.”

When Scott was asked about purchasing from China, Matthew R. Beebe, director of acquisitions for the Defense Logistics Agency, agreed that the military should not buy from them, but said the reality is that current regulations sometimes require it. “We don’t buy from China unless it’s the only source available,” Beebe says. If the finished product is available domestically or in an ally country, they will buy it there, he added.

“But we don’t always have visibility into the origins,” the ingredients used to make the drugs, called active pharmaceutical ingredients, and the ingredients used to make those APIs, Beebe said.

About 5% of active pharmaceutical ingredients come from China, Martinez-Lopez said, but officials cannot determine the source of about 20% of the rest.

The percentage of those unknown sources is “just so disturbing that I don’t even know how to characterize the risk,” Beebe said. He and the other officials said they support bringing more manufacturing back to the US

Scott questioned the witnesses as to why the military could not immediately stop purchasing pharmaceutical products that are in any way sourced or produced in China. Due to the large number of drugs that would fall into this category, this would mean that some drugs would not be available, officials said.

Of the 60 essential medicines in the U.S., about 20% are sourced exclusively from China, said retired Army Col. Victor A. Suarez, founder of Blu Zone Bioscience & Supply Chain Solutions.

For many of these drugs, it is not economically feasible for companies to produce them here in the U.S., Suarez said. In recent decades, a large part of pharmaceutical production has moved abroad. China has used its competitive advantages – such as cheap labor – to drive down prices, forcing some American companies out of business.

And 40% of generic drugs sold in the U.S. have just one manufacturer, Warren said.

Scott asked the DOD witnesses to help draft a letter to several associations in the healthcare community inviting them to a conference call for ideas on helping build a domestic market for pharmaceuticals. The letter is believed to have come from Defense Department and other government officials, as well as members of Congress, Scott said.