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# Reps Seek FDA Action on Drug Research in China
- URL: https://www.fdaweb.com/reps-seek-fda-action-on-drug-research-in-china/
- Published: 2024-08-20T12:00:00.000Z
- Updated: 2026-09-14T14:38:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157610

A bipartisan group of four House members is asking FDA commissioner **Robert Califf** to tell what steps the agency is taking to counter potential issues associated with drug companies conducting trials with medical centers and hospitals associated with China’s People’s Liberation Army (PLA). The [letter](https://www.documentcloud.org/documents/25052080-81924-fda-letter-on-pla-trials?responsive=1&title=1&ref=fdaweb.com) says such trials usually produce sensitive and proprietary data, which could lead to intellectual property being transferred to Chinese interests. It says there also are concerns about the trustworthiness of clinical trial data produced overseas from PLA institutions, noting that FDA previously has declined to approve oncology treatments based on clinical trial data solely produced from clinical trial sites in China, “suggesting that FDA should also impose similar scrutiny to clinical trial work done in cooperation with the PLA.”

The letter also cites concerns specifically about trials being conducted in the Xinjiang Uyghur Autonomous Region (XUAR) “where the Chinese Communist Party is engaged in genocide of the Uyghur population. Given the historical suppression and medical discrimination against ethnic minorities in this region, there are significant ethical concerns around conducting clinical trials in the XUAR.”

The letter says that while FDA primarily determines whether responsible parties are complying with requirements for submitting information to ClinicalTrials.gov and meeting regulatory guidelines, regulations specifically grant the commissioner the authority to request and analyze data from clinical trials domestically and outside of the U.S. Thus, it says, data from drug companies who conducted clinical trials at institutions affiliated with the PLA or other organizations in the XUAR are likely already in FDA’s possession.”

The representatives ask for responses to these questions:

- whether FDA has reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities;
- whether FDA has ever been denied access to foreign clinical trial sites in the People’s Republic of China (PRC);
- the number of PLA-owned, operated, affiliated facilities FDA has reviewed for clinical trial work;
- FDA’s estimated average cost for adjudicating a clinical trial conducted in the PRC;
- the earliest date for which FDA received clinical trial data that included PLA organizations;
- whether FDA has ever notified any U.S. biopharmaceutical organization that it has conducted studies with the PLA or in the XUAR, and the number of notices, when they were issued, and if the companies were responsive; and
- the metrics FDA uses when assessing intellectual property and technology transfer risks.

“The United States needs FDA to take on a greater role in protecting U.S. national security interests,” the letter concludes. “With this data, it is clear that FDA should play a greater role in analyzing U.S. biopharmaceutical entities’ clinical trial operations in the PRC.”