GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit

Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China.

Their proposal would require the FDA to reject any data from a Chinese trial site unless the site has been inspected by the agency within a recent timeframe, and to launch a broad review of existing products that depend on such data.

The request follows a series of deaths at an investigational site in China, which lawmakers say highlight gaps in current monitoring practices.

If adopted, the measures could force sponsors to seek additional audits or shift portions of their development programs away from Chinese locations, potentially slowing the entry of new therapies.