Republicans raise questions about China-only drug applications

Republican members of a congressional committee with jurisdiction over FDA Friday expressed concern over a “surge” in Chinese clinical trials and requested data from FDA about submissions of drugs based solely on data from China. Their concerns come months after the agency has taken firm action to bar U.S. approvals, with limited exceptions, of cancer drugs supported by data generated entirely or mostly in China. 

In a letter to FDA Commissioner Rob Califf, the Republicans cited statistics on the number of clinical trials started in the U.S. and China, noting that from 2016 to 2018 the percent of trials worldwide initiated in China increased from 12.5% to 21.6%. “In just two years, China went from having half the initiations of the U.S. to pulling even” with the U.S, they wrote...