Regulatory Focus™ > News Articles > 2022 > 5 > House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections

Regulatory NewsRegulatory News
Posted 25 May 2022 | By Jeff Craven 

House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections

2767 Republicans in the House Committee on Energy and Commerce have sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf asking him to provide information about drugs approved solely based on data from clinical trials conducted in China and details about FDA trial site inspections in China.

In their letter, Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-FL), and H. Morgan Griffith (R-VA), said they are concerned about an increase of FDA drugs approvals with clinical trials conducted solely in China. According to data analytics company GlobalData, trial initiations from China increased from 15.5% in 2017 to 21.6% in 2018, while trial initiations decreased from 23.7% to 21.6% over the same timeframe. “This surge of clinical trials conducted in China is starting to manifest itself in FDA submissions,” they wrote.
This is a particular problem in oncology with immune checkpoint inhibitors, the representatives said. Richard Pazdur, director of the FDA’s Oncology Center of Excellence (OCE), recently wrote in a comment published in The Lancet Oncology that at least 25 applications with data solely from China are in various stages of development, submission, or review. “Many sponsors of trials performed in China began their clinical development in China after results of other checkpoint inhibitors in the disease were publicly available,” the representatives said.
The representatives also called attention to a trend of “me too” drugs where developers are seeking to use data from other checkpoint inhibitors as the basis for their submissions to FDA. “These drugs are not biosimilar or generic drugs and, thus, are required to have complete clinical and non-clinical studies and manufacturing processes developed,” they said. “These drugs cannot rely on information generated by the already-approved checkpoint inhibitors.”
One notable recent example of this was sintilimab, a PD-1 monoclonal antibody checkpoint inhibitor for metastatic non-small cell lung cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that data from the China-based ORIENT-11 trial wasn’t sufficient to make a regulatory decision in the US market for sintilimab, and that more data for US patients was needed. (RELATED: FDA officials, advisors cast doubt on foreign-only clinical strategy, Regulatory Focus 10 February 2022)
Rodgers, Guthrie and Griffith also raised concerns about the quality of clinical data from China. “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.
To that end, 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 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.”


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you