Washington – There’s increasing concern in Congress about the impact of the coronavirus on the nation’s supply of pharmaceuticals as many U.S. drugs depend on active ingredients from China and other countries in the virus’ grip.
Sen. Chris Murphy and Rep. Rosa DeLauro are among the lawmakers leading efforts to determine whether the virus will cause a scarcity of lifesaving drugs.
“I heard from medical professionals in Connecticut over the weekend who are concerned about potential drug shortages here in the United States as a result of the coronavirus epidemic and are having regular talks with suppliers about potential shortages,” said Murphy.
The issue of the pandemic’s impact on the nation’s drug supply was discussed Wednesday at a House Appropriations subcommittee hearing on the National Institutes of Health budget chaired by DeLauro, D-3rd District.
“I was somewhat surprised-slash-shocked that 90% of the ingredients that go into drugs… come from China,” testified Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, at that hearing.
DeLauro said she will call Rosemary Gibson, the co-author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine,” to testify at a hearing of her appropriations subcommittee, which has jurisdiction on federal health spending.
DeLauro has been urging her colleagues to read Gibson’s book. She also said she would hold a hearing on “what we can do to make these ingredients here.”
On Wednesday, the Congressional Progressive Caucus sent a letter to the CEOs of leading pharmaceutical companies seeking information on potential supply chain drug shortages due to the coronavirus epidemic.
The information sought included “the number of drugs manufactured by your members that contain an ingredient only found or produced in China or other countries critical to the global supply chain.”
At DeLauro’s hearing, Rep. Jaime Herrera Beutler, R-Wash., said she has attended briefings by Vice President Mike Pence, who has been tasked with coordinating the nation’s coronavirus response, and been told “we’re fine, we’re fine, we’re fine,” when she asked about the integrity of the nation’s drug supply.
“But this past week we’ve been hearing there are some concerns,” Herrera Beutler said. “We’ve already seen shortages.”
The Food and Drug Administration alerted the public last week about the first drug shortage related to coronavirus, but the agency declined to identify the drug.
Pharma from overseas
According to Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, 72% of API manufacturing takes place outside the U.S., and that the number of facilities making APIs in China has more than doubled since 2010.
The United States “has become a world leader in drug discovery and development, but is no longer in the forefront of drug manufacturing,” she told Congress in October 2019.
But China is not the only country that partners extensively with the U.S. on pharmaceutical production.
“The U.S. imports billions of dollars worth of pharmaceuticals and medical devices from China, and I remain worried about how to ensure the integrity of these products in the midst of this coronavirus outbreak.”
Sen. Chris Murphy
On Tuesday, authorities in India ordered the country to stop exporting 26 drugs and drug ingredients, most of which are antibiotics, without government permission. The move is seen as an attempt by the Indian government to make sure there is an adequate supply of these medications in India first.
FDA Commissioner Stephen Hahn said that since news broke of the outbreak in China on Jan. 24, his agency has been in touch with more than 180 drug manufacturers “not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China.”
Active pharmaceutical ingredients, or APIs, are the main ingredient in a drug and the one that produces its intended effects.
“We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way,” Hahn said.
The specter of drug and medical supply scarcities prompted Murphy, D-Conn., and Marco Rubio, R-Fla., to write to the FDA early last month about their concerns.
The senators asked the FDA if it had enough resources to ensure the coronavirus does not impact the U.S. supply of pharmaceuticals and how many FDA employees were still in China to inspect the drugs, medical devices and food being exported to the United States.
The senators also asked if the FDA expects shortages of drugs or medical supplies and what steps the agency has taken to fill any supply shortages.
In a five-page response, Karas Gross, the FDA’s associate commissioner for legislative affairs, said the agency is working with the Department of Health and Human Services to assess its needs, and that anticipation of shortages “remains an evolving situation.”
Gross reminded the senators that while drug manufacturers must notify the FDA of supply disruptions, medical supply companies do not.
Gross also told the senators that FDA inspections of Chinese-manufactured drugs, food and medical devices have stopped due to the State Department’s warning against travel to China. But he cited other ways the FDA is ensuring those products are safe, including increased import sampling and screening.
“The robust and multi-layered compliance process at FDA is continuing to protect American patients and consumers even though we are not able to conduct inspections at this time,” Gross wrote.
“I appreciate that the FDA got back to me on these concerns – but their response did not leave me reassured,” Murphy said. “The U.S. imports billions of dollars worth of pharmaceuticals and medical devices from China, and I remain worried about how to ensure the integrity of these products in the midst of this coronavirus outbreak. I’m going to continue to press the administration until we get answers on how they plan to deal with the potential fallout if these fears come to fruition.”
Supply chain vulnerabilities
Several U.S. pharmaceutical companies, including Pfizer, AstraZeneca, and Merck, have warned in their latest filings with the U.S. Securities and Exchange Commission that the coronavirus could impact production.
“The extent to which the coronavirus impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others,” Pfizer said in its filing.
The company said the continued spread of the coronavirus globally “could adversely impact our operations, including among others, our manufacturing and supply chain.”
But Pfizer spokeswoman Amy Rose said the company has not experienced any disruptions to date. “We consistently and diligently monitor the supply of our medications,” Rose said. She also said Pfizer has a six- to 12-month supply of APIs and its “finished goods” inventory is typically two to three months.
Stamford-based Purdue Pharma said in an emailed statement that the company has created “an active coronavirus reaction team” to monitor the situation. “Currently, we have not identified any specific supply chain risks.”
Personally, think there is much more political hype about COVID-19 than there is real danger. I don’t mean to downplay the caution needed to reduce the spread of any communicable disease or illness, but I believe the politicians are also using this to keep their names in the newsfeeds.
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Perhaps companies will begin to recognize that the additional profit margin associated with outsourcing to China comes at a cost to our society. Consider who is the primary source of Fentanyl and its various permutations. Yet these companies rely on China and other countries to provide the APIs needed for our market.
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Has anyone considered how vulnerable this make the United States?
You mean those drugs for which Americans pay the highest prices in the world come from China? Not long ago Big Pharma justified the difference in cost between drugs bought in the US and those sold overseas on the basis our drugs were made in heavily regulated American factories. Turns out that was a big, fat lie. It is time to nationalize the drug industry. Seize all their patents. Start a quasi-government organization to make drugs and distribute them. Suddenly insulin will be $10/month.