Trump taps aide Heidi Overton for FDA, pledges to speed new treatments

• President Trump nominated Heidi Overton to lead the FDA, aiming to speed new treatments and reform clinical trials amid agency turmoil.
• Overton is a medical doctor with White House experience and seen as a neutral choice without controversial regulatory views.
• She faces Senate confirmation and the challenge of stabilising the FDA after many leadership departures during a tense political climate.

WASHINGTON – US President Donald Trump nominated White House policy aide Heidi Overton to lead the Food and Drug Administration (FDA) after a turbulent year at the agency marked by high-profile staff exits and industry complaints.

Overton is a deputy assistant to the president for domestic policy at the White House working on health issues.

She worked at the think-tank America First Policy Institute, is a medical doctor and has a doctorate in clinical investigation from Johns Hopkins University.

She was also a White House fellow in the first Trump administration.

Trump announced the selection in a social media post, confirming an earlier Bloomberg News report.

He said she would work to speed up new treatments, boost US innovation and reform clinical trials.

The FDA, which regulates products that account for roughly a fifth of consumer spending in the US, has been in turmoil for months.

Former commissioner Marty Makary resigned in May after 13 months in the top role marred by clashes with staff and pushback from biotech companies.

Soon after, a wave of other senior leaders departed.

Kyle Diamantas, an attorney who led the agency’s food division and was a senior adviser to Health Secretary Robert F. Kennedy Jr, has been acting commissioner.

The White House offered Diamantas the permanent role, but he declined, according to people familiar with the matter.

Overton has been a frequent fixture in Oval Office announcements on health issues alongside Trump, including on vaccine policy, drug pricing and access to psychedelic treatments.

She has also spoken publicly about the administration’s response to the ongoing Ebola outbreak. 

Analysts viewed Overton as neutral for the pharmaceutical industry, with little established track record on regulatory policy.

Brian Abrahams, head of global healthcare research at RBC Capital Markets, called her an “unsurprising” choice who “comes into the role without any overly controversial vocal stances around drug regulation or expressed desires to remake the FDA”.

That may mean more autonomy for staff, he wrote in a research note, “and eventually, more stability, which we believe many would welcome”.

The FDA commissioner is usually not involved in product-level approval decisions.

The Trump administration has not yet announced permanent leaders for FDA’s division regulating drugs and a separate centre overseeing gene therapies and vaccines.

Those selections will be important for the industry to understand the administration’s posture towards product reviews. 

Overton has also cultivated longstanding relationships in Trump’s orbit.

She left her surgical residency at Johns Hopkins to continue working in the White House during Trump’s first term.

She worked under Brooke Rollins, now the Agriculture Secretary, in her first stint at the White House and at the America First Policy Institute.

Rollins called Overton one of her “best friends” in a social media post on Aug 19.

Overton also served on the transition team for the second Trump administration.

She will have to navigate a Senate confirmation process run by health committee chairman Bill Cassidy, a Louisiana Republican and gastroenterologist who has had a tense relationship with both Kennedy and Trump.

Republican senators have criticised the FDA for not moving faster to restrict prescribing of abortion pills via telehealth and for some of the agency’s decisions related to the reviews of drugs to treat rare diseases.

If confirmed, she will face the task of stabilising an agency roiled by an unprecedented level of leadership turnover.

Given the wide variety of industries the FDA oversees, its commissioner routinely must navigate pressures from external actors and forces inside the administration. 

The agency regulates products that have been priorities of Kennedy and the White House, including vaccines, injectable peptides, e-cigarettes and much of the food supply.

“Being able to manage a team and sort through complex issues is a big part of what Heidi has done in the last 18 months in the White House,” said former Trump White House healthcare policy official and Paragon Health Institute president Brian Blase. BLOOMBERG