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11 December 2019Big PharmaSaman Javed

US senators question ‘national security risks’ posed by Chinese drugs

US senators have requested information regarding the national security risks posed by the role of foreign manufacturing, specifically in China, in the US pharmaceutical products supply chain.

In a letter, published December 5, a group of four bipartisan senators said that in light of a recent report from the US-China Economic and Security Review Commission, which highlights the US’ "growing reliance" on drugs made in China, it is “critical that the Department of Defense (DoD) address the dangers posed by US reliance on foreign drug makers.

The letter, which was addressed to the US secretary of defence, Mark Esper, referred to the commission’s 2019 US-China relations Annual Report.

The senators said that despite the critical role of active pharmaceutical ingredients (API) in drug production, China is now the world's leading producer of APIs and accounts for more than 20 percent of total global output.

Active pharmaceutical ingredients are raw chemical components of drugs that have a direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease.

This “systematically undercuts market prices, forcing US, European and Indian producers out of business”, the letter said.

“Globally, the data is also alarming as India is fully dependent on APIs imported from China. More concerning, the US relies on imports of general antibiotics from China—including penicillin, the most basic component of antibiotics—for diseases and infections across the spectrum,” it added.

Additionally, the senators said there is evidence disputing the reliability of Chinese pharmaceutical products.

In 2018, the US Food and Drug Administration found N-Nitrosodimethylamine, a known carcinogen, in the popular blood pressure medicine valsartan.

The contaminant was traced back to one of China's largest pharmaceutical ingredient manufacturers, after the drug was sold to millions of people in 23 countries, including to US service members and their families.

“Medicines can be used as a weapon of war against the United States,” the letter said.

“In the hands of an adversary, they can be weaponised. Supplies can be withheld. Medicines can be made with lethal contaminants or sold without any real medicine in them, rendering them ineffective,” the senators warned.

The senators also asked the DoD to answer a number of questions relating to the report’s findings.

They asked if the DoD had identified a list of drugs, APIs or other pharma products that are vulnerable to foreign interference.

They also asked if the DoD had conducted an assessment of its supply chain, and how it decides which vendors or manufacturers to take out contracts with.

The letter was signed by Elizabeth Warren, Tom Cotton, Tim Kaine and Mitt Romney.

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