Former FDA official says leadership turnover won’t derail push for faster US drug trials

The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, however, continue to agree on the importance of accelerating early‑stage clinical trials and returning them to the United States.

Tala Fakhouri, Parexel’s chief artificial intelligence and regulatory strategy officer and a former FDA AI policy official, said the White House and the Department of Health and Human Services have made it clear they want the U.S. to remain the top destination for drug development and to bring early trials and manufacturing back home.

Fakhouri cautioned that policy statements alone will not achieve the goal. She emphasized that the real challenge lies in the implementation of those policies, noting that more concrete actions are needed to translate intent into faster trial timelines.

While turnover at the FDA’s top levels, including the departure of Commissioner Martin Makary, adds complexity, Fakhouri believes the overarching priorities are unlikely to shift. The success of the acceleration effort will depend on how effectively the agency and industry execute the outlined strategies.