On May 20, 2022, three Republicans on the House Committee on Energy and Commerce sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, asking him to provide information about drugs that were approved solely based on data from clinical trials conducted in China.
The three Representatives – Cathy McMorris Rodgers, Brett Guthrie, and H. Morgan Griffith – also sought details about FDA trial site inspections in China. The Representatives noted that they are concerned about an increase in FDA drug approvals with clinical trials conducted solely in China.
They refer to the “current ‘East to West’ movement of clinical data,” where most drugs discussed with the FDA are replicas of drugs already on the market, seemingly lessening innovation. Because these drugs are not biosimilar or generic drugs, they are are required to have complete clinical and non-clinical studies and manufacturing processes developed. “These drugs cannot rely on information generated by the already-approved checkpoint inhibitors. As such, there is a lot of redundancy and expense for questionable benefit,” the letter reads.
The Representatives also raised concern over diversity issues, referencing a recent statement by FDA officials Harpreet Singh and Richard Pazdur, which noted “trials relying solely on enrollment from a single country might have less ethnic and racial representation relevant to the US population, notably with regards to currently underserved groups.” Singh and Pazdur recommended that additional data be provided for clinical trials performed outside the United States, “to ensure the generalizability of their results to the US population.”
In the letter, the Representatives raised concerns about the quality of clinical data from China. There was a 2016 report in the British Medical Journal that found 80% of trials conducted in China had data quality issues. While the FDA acknowledges that there have been steps taken in the past 6 years to address these issues, the Representatives are seeking information on this topic as well. “In general, FDA has indicated it would want to explore whether any of the sites in a particular trial were involved in these withdrawals, and what was done to rectify the specific situation,” they said.
Information Requested
The representatives asked Califf to identify the number of biologics license applications and drug applications with clinical trials mainly in China, how many clinical trial sites FDA inspected in China prior to the COVID-19 pandemic and their outcomes, and any clinical trial sites in China involved in data withdrawals. The representatives also requested that Califf elaborate on how FDA could address data integrity issues, and whether clinical trial sites in China represented “a significant number of patients in international, multi-regional clinical trials submitted to regulatory agencies.”
Letter to GAO
In addition to this letter, the same Representatives sent a letter to Comptroller General of the United States Gene Dodaro, requesting that the Government Accountability Office (GAO) conduct a review of the FDA’s Bioresearch Monitoring Program (BIMO), a key component of FDA’s mission to ensure that drugs are safe and effective before approval.