A bipartisan group of U.S. lawmakers has launched national security investigations into Merck & Co. Inc. (MRK) and AbbVie Inc. (ABBV) over concerns that clinical trials conducted in China may have exposed sensitive U.S. biotechnology research to ethical and security risks.
The lawmakers are seeking details about the companies' clinical trial operations, data protection measures, and due diligence practices at research sites across China, including facilities in Xinjiang and military-affiliated hospitals.
China's Expanding Role In Drug Development Under Scrutiny
According to Reuters, China's share of global early-stage drug development programs climbed to more than 32% by 2024, up from 8% in 2015, while the U.S. share declined to about 37% from 48% over the same period.
Merck has sponsored or collaborated on 224 clinical studies in China since 2005, including at least 31 in Xinjiang and 40 at military-affiliated hospitals and medical centers.
AbbVie has participated in more than 100 studies in China since 2007, including at least 17 sites in Xinjiang and 16 military-affiliated centers.
The lawmakers said conducting research at military hospitals could place the biotechnology intellectual property of American companies at risk of being transferred to the Chinese military.
Congress Seeks Details On China Clinical Trial Practices
Citing letters dated Monday, Reuters reported that lawmakers led by Rep. John Moolenaar, the Republican chairman of the House Select Committee on the Chinese Communist Party, asked both drugmakers to respond by July 17.
The committee requested information on due diligence procedures, data security safeguards, and operating standards at Chinese clinical trial sites, with particular focus on facilities in Xinjiang and hospitals affiliated with China's military.
The letters state there is no evidence that either company engaged in illegal activity or wrongdoing.
However, lawmakers argued that conducting clinical trials in China could expose U.S. companies to ethical concerns and national security risks.
Lawmakers Cite Security And Ethical Risks
The committee said Xinjiang remains the center of Beijing's campaign against Uyghurs and other ethnic and religious minorities.
It also cited reports from Chinese researchers documenting shortcomings in obtaining informed consent from clinical trial participants.
Lawmakers noted that while the Uyghur Forced Labor Prevention Act of 2021 does not specifically cover clinical trials, it reflects broader best practices aimed at avoiding operations linked to forced labor and other ethical concerns.
Citing the letters, Reuters also noted that China's combination of regulatory changes, government subsidies, and what lawmakers described as questionable ethical standards has made the country one of the world's fastest and least expensive locations for early-stage drug development.
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