By Yasmeen Abutaleb
WASHINGTON, Aug 19 (Reuters) - U.S. President Donald Trump named White House policy aide Heidi Overton to lead the Food and Drug Administration, turning to an "America First" ally to steady an agency shaken by staff losses, low morale and fights over vaccines, the abortion pill and drug approvals.
Trump's previous FDA commissioner, Marty Makary, resigned in May after 13 months in the job, following clashes with White House officials over flavored vapes, a stalled abortion-pill safety
study and public disagreements with drugmakers such as Replimune, Sarepta and Moderna over reviews of potentially lifesaving medicines and vaccines.
The choice of Overton, an ally of Makary, may deepen concerns among drugmakers and some FDA staff seeking stability after months of upheaval. Chris Meekins, a former Trump health official who is now an analyst at Raymond James, said industry groups are likely to view Overton's lack of management experience negatively and warned her appointment could accelerate staff departures and reverse progress made since Makary's exit.
Overton, a doctor by training who serves as deputy director of the White House domestic policy council, must be approved by the U.S. Senate. She previously worked at the America First Policy Institute, a conservative think tank.
"She is known to take on the HARDEST issues, and bring me solutions that work best for the Country," Trump wrote in a social media post on Wednesday. "We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES."
FDA FACES NUMEROUS CHALLENGES
The FDA has faced numerous challenges in Trump's second term, including an exodus of experts and top talent and plummeting morale after Health Secretary Robert F. Kennedy Jr. fired thousands of people across the health department.
The agency, which is responsible for regulating and approving all drugs, treatments and vaccines, has lost more than 3,000 staff over the past year, including division heads, and is under pressure to rebuild confidence among industry and public-health groups.
Overton's nomination coincides with new efforts by Trump health officials to take action on a number of controversial issues, including autism and vaccines as well as the abortion pill.
Overton spoke at a White House event last week at which Trump announced a new executive order that calls for significantly cutting back the national childhood vaccination schedule and splitting the measles, mumps and rubella (MMR) vaccine into three separate shots, which pharmaceutical companies said could take years.
"Heidi brings exceptional judgment, professionalism, discipline, and an unwavering commitment to the American people. I have seen her challenge assumptions, demand excellence, and turn bold ideas into meaningful results," Kennedy wrote on X.
Overton is likely to be viewed skeptically by pharmaceutical companies and a broader healthcare industry looking for stability at the embattled agency.
Meekins, a health official in Trump's first term, wrote in an analyst note on Wednesday that Overton has "seemingly no real experience running anything of consequence."
"Industry will view this pick as extremely troublesome and FDA career staff will continue to flee the agency in my view," Meekins wrote. "Any progress made since Makary's departure is likely to be quickly reversed if she is confirmed."
Kennedy has struggled to retain top health officials, creating turbulence at federal agencies responsible for nearly $2 trillion in government spending. Erica Schwartz earlier this month was confirmed as director of the Centers for Disease Control and Prevention. The role had been vacant for over a year after Kennedy fired Susan Monarez within weeks of her confirmation due to a clash on vaccine policy.
Kyle Diamantas has served as acting FDA chief since May. Under his watch, the agency has reversed course on several drug approvals or reopened regulatory consideration 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.
It remains unclear whether Overton will continue Diamantas' approach. Trump in recent months has pressed Kennedy for more action on vaccines and what Trump and Kennedy say is a possible link to autism, a view refuted by years of scientific research.
Overton's appearance and endorsement of Trump's executive order on vaccines last week unnerved some career staff at FDA, according to a person familiar with the dynamics.
(Reporting by Ismail Shakil and Susan Heavey; Editing by Alison Williams and Howard Goller)
