Dive Brief:
- The Food and Drug Administration has accused another Chinese facility of copying results from another study or falsifying data.
- FDA officials, who published the claims on May 22, accused Sanitation & Environment Technology Institute of Soochow University of wrongdoing after seeing “highly improbable” data from tests the lab performed on guinea pigs.
- The FDA will reject all data from studies run at the Chinese lab, which does business as SDWH, until it adequately addresses issues raised in the letter to show its results are reliable and valid.
Dive Insight:
The FDA flagged an “alarming” rise in the inclusion of fabricated, duplicated or otherwise unreliable data in premarket submissions in February 2024. Within weeks of issuing the alert, the FDA inspected SDWH and Mid-Link Technology Testing, which the agency also calls Mid-Link Testing Company. The agency sent warning letters to both companies in September.
Mid-Link received a letter focused on the FDA’s data integrity concerns in February. The FDA published the letter in March, revealing the agency had concluded Mid-Link copied or falsified results and as such it had “no reason to believe” any data produced at the lab are reliable.
The FDA leveled the same accusations at SDWH in a letter it sent earlier this month. As happened in the Mid-Link investigation, the FDA used “implausible” weight gain data to make the case that SDWH copied results from another study or falsified the findings. The FDA raised its concerns with SDWH late last year.
SDWH’s response failed to address the FDA’s concerns about the causes of the data anomalies, whether other studies may have similar problems and why the evidence of falsification should not raise questions about the validity of all data generated by the lab. The company sent additional responses in February and March that were still under review when the FDA sent the letter earlier this month.
The FDA, which also called SDWH’s response to the earlier warning letter inadequate, said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data and have potential implications for patient safety.
“Patient or user exposure to a medical device could result in adverse health effects such as cytotoxicity, allergic reactions, skin irritation or inflammation, fever, toxicity that leads to loss of tissue/organ function or failure and anaphylaxis,” the FDA said. “These adverse health effects represent a clear risk to patients and clinical practitioners.”
Like Mid-Link, SDWH needs to address the concerns before the FDA will accept its data in submissions. The company’s response may include the implementation and adherence to procedures that prevent the use of copied, falsified or otherwise invalid data, the agency said. The FDA may inspect SDWH to verify corrective actions and its future regulatory compliance.
