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Test tubes are seen in front of a displayed Abbvie logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tab
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Summary
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Companies
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Merck, AbbVie asked to provide trial details by July 17
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Trials in Xinjiang and military hospitals under scrutiny
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China has overtaken US in early drug development
June 30 (Reuters) - A bipartisan group of U.S. lawmakers has opened national security investigations into whether drugmakers Merck (MRK.N), opens new tab and AbbVie (ABBV.N), opens new tab have been involved in clinical trials conducted in China that helped fuel the communist country's military capability, according to letters seen by Reuters.
In the letters dated Monday and first reported by Reuters on Tuesday, lawmakers led by Republican Representative John Moolenaar of Michigan, chair of the China Select Committee, asked the drugmakers to provide by July 17 details of due diligence, data protection processes and other standards at their trial sites in China, particularly in the Xinjiang region and at military hospitals.
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Merck said patient safety and ethical integrity are priorities of its clinical research program and it follows all global guidelines. AbbVie declined to comment.
A spokesperson for China's embassy in the U.S. in an email said that there is "nothing credible" in the committee's actions and China opposes moves to politicize trade and tech issues.
The letters note that Xinjiang is the epicenter of Beijing's " genocide" targeting Uyghurs and other ethnic and religious minorities. They say Chinese researchers have documented lapses in securing informed consent, opens new tab from trial participants.
The Uyghur Forced Labor Prevention Act of 2021 does not specifically address clinical trials, but it reflects best practices given the ethical risks of making sure operations do not involve forced labor, the letters said.
"Through a combination of regulatory reforms, state subsidies, and (at best) questionable ethics, China has transformed itself into the cheapest and fastest place in the world to run early-stage human drug trials," the letters said.
China in recent years has outstripped the U.S. in trial volume, opens new tab. By 2024, the U.S. share of global early drug development programs had dropped to around 37% from 48%, opens new tab in 2015, while China's share rose to over 32% from 8%, according to one study.
The Merck and AbbVie investigations are the latest sign of growing U.S. government concern over China's role in the biotech industry. The National Security Commission on Emerging Biotechnology in a December report, opens new tab warned that "China has systematically built a vertically integrated biotechnology ecosystem that is now in prime position to challenge U.S. leadership."
The letters to AbbVie CEO Robert Michael and Merck CEO Robert Davis say that "while there is no evidence" that either company "has engaged in illegal activity or wrongdoing, conducting clinical trials in China ... exposes American companies to ethical and security risks."
The committee said New Jersey-based Merck has sponsored or collaborated in 224 clinical studies in China since 2005, including at least 31 trials in Xinjiang and 40 at medical centers and hospitals affiliated with China's military.
It said Illinois-based AbbVie has sponsored or collaborated on more than 100 clinical studies in China since 2007, including at least 17 sites in Xinjiang and 16 at military centers.
"Conducting this research at PRC military hospitals puts the cutting-edge, biotechnology Intellectual Property of American companies at potential risk of being transferred to the Chinese military," the letters said.
Moolenaar is also sponsoring a bipartisan bill, the Biotech Investment National Security Act, opens new tab, that would amend last year's Comprehensive Outbound Investment National Security Act to add biotech to a list of screened technologies. The legislation would require outbound U.S. biotechnology licensing deals, joint ventures and equity investments in China to be subject to strict national security review.
The Biosecure Act, opens new tab signed into law by President Donald Trump late last year, restricts federal agencies' business dealings with non-U.S. biotechnology companies.
Reporting by Deena Beasley in Los Angeles; Editing by Caroline Humer and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles., opens new tab
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