FDA questioned on China

Three US senators have questioned the FDA about clinical trials of drugs in China.

The republican members of the House Committee on Energy and Commerce have expressed concern about an increase of FDA drug approvals based on what they call a ‘surge of clinical trials’. Data suggests that trial initiations increased from 15.5% in 2017 to 21.6% in 2018 and it’s these results that they say are now beginning to show.

The GOP representatives have said that there is a particular problem relating to oncology with immune checkpoint inhibitors. Information recently published in The Lancet Oncology outlined that many sponsors of the clinical study of drugs in humans in China began their development after the results of other checkpoint inhibitors were publicly available.

They also referenced a trend of ‘me too’ drugs where developers seek to use data from other checkpoint inhibitors as the basis of their data. The complaints to the FDA outline that these drugs still require complete studies and manufacturing processes developed and cannot rely on the information generated by already approved checkpoint inhibitors.

Concerns were also raised about the quality of clinical data.

The representatives requested that FDA Commissioner Robert Califf identify the number of licence and drugs applications for China-based trials, how many trial sites they inspected there pre-pandemic and their outcomes, and for any trial sites involved in data withdrawals.

They also requested the FDA to elaborate on how they could address data integrity issues and whether clinical trial sites in China represent a significant number of patients in international, multi-regional clinical trials submitted to regulatory agencies.