Trump picks White House adviser Heidi Overton to run FDA, source says

By Yasmeen Abutaleb and Carlos Méndez

Aug ‌18 (Reuters) - U.S. President ​Donald Trump ​has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, a source familiar with the matter said on Tuesday, months after previous chief ‌Marty Makary quit.

If approved by the Senate, Overton will take over an FDA that ⁠has lost more than 3,000 staff, including division heads, over the past year, and is under pressure to rebuild confidence ‌among industry and public-health groups amid ‌concerns the regulator has become too political.

The White House, the FDA and Overton did not immediately respond to Reuters' requests for comment.

Overton, a doctor by training, is currently deputy director of the White ​House domestic policy council and has previously worked at the America First Policy Institute, a conservative think tank.

She received her medical degree from the University of New Mexico, trained in general surgery ⁠at Johns Hopkins, and pursued clinical-investigation research training at the Johns Hopkins Bloomberg School of Public Health.

Last week, Overton appeared at a ​White House event where Trump announced an executive order that calls for reducing the childhood vaccine schedule and splitting the measles, mumps and rubella vaccine into ​three separate shots, which could take drug developers years to ‌achieve.

Overton was among three candidates, including oncologist Jeffrey Vacirca and Pentagon health official Stephen Ferrara, the administration focused on for Trump to nominate as FDA commissioner, ⁠Reuters reported earlier.

Kyle Diamantas has been running the agency as acting chief since May, when Makary resigned 13 months into the job after clashing with top White House and health advisers and drawing scrutiny for a series of ⁠controversial agency decisions.

Makary drew criticism for his handling of the reintroduction of flavored vapes into the U.S. market, a stalled ​abortion-pill review and public disagreements with drugmakers such as Replimune, Sarepta and Moderna over reviews of potentially lifesaving medicines and vaccines.

Since Diamantas took over as acting chief, the FDA has reversed course or reopened regulatory paths for rare-disease ‌therapies from Regenxbio, uniQure and Replimune.

It also launched steps aimed at speeding up drug research by pairing sponsors with qualified research institutions to shorten the time from ‌drug identification to first-in-human studies.

Before Makary's exit, the FDA's biologics division chief Vinay Prasad departed in April amid controversy ⁠over vaccine trial revisions and rare-disease drug ‌rejections.

Bloomberg News reported first that ​Trump picked Overton to lead the FDA.

(Reporting by Yasmeen Abutaleb in Washington, Carlos Méndez in Mexico City, Christy Santhosh in Bengaluru; Editing by Jacqueline Wong, Tom Hogue and ‌Sonali Paul)

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