* Makary criticized on drug approvals, abortion, flavored

vapes

* Wall Street Journal and anti-abortion groups called for

exit

* FDA struggles with leadership turnover, staff

departures

By Yasmeen Abutaleb and Jarrett Renshaw

WASHINGTON, May 8 (Reuters) - The White House signed off

on a plan to fire U.S. Food and Drug Administration Commissioner

Marty Makary, according to sources familiar with the matter, in

what could be the next leadership change within the federal

health department.

The Wall Street Journal earlier on Friday first reported that

President Donald Trump planned to fire Makary.

Two of the sources, who are advisers to the White House,

said a decision was not final. A third source close to the White

House said they were told the FDA commissioner "is done" and

that Trump signed off.

The White House did not defend Makary as reports emerged of

his imminent ouster, but at least publicly, Trump has not said

he would replace him.

"No, no," Trump said on Friday evening when a reporter asked

whether he would bring in someone new to lead the FDA.

Top officials have been discussing possible replacements for

Makary in recent days, according to the three people. But they

cautioned the decision always rested with Trump and that the

president could change his mind at the last minute, as he has

during past staffing crises.

It remains unclear whether Trump will still move forward

with firing Makary or whether he has fully reversed course.

White House spokesman Kush Desai earlier said: "President

Trump has assembled the most experienced and talented

administration in history, an administration that continues to

focus on delivering more historic victories for the American

people."

The U.S. Department of Health and Human Services, which

oversees the FDA, was not available for comment.

MAKARY FACES MOUNTING CRITICISM

His firing would follow a series of controversies that drew

criticism from Trump allies, supporters of Health Secretary

Robert F. Kennedy Jr., conservative media, pharmaceutical

companies and anti-abortion groups.

The conservative Wall Street Journal editorial board published

more than half a dozen pieces criticizing Makary's stewardship

of the agency. One opinion piece asked whether any

administration official had created more headaches for Trump

than Makary, pointing to the FDA's twice-repeated rejection of

Replimune's ( REPL ) melanoma therapy.

Makary in an interview on CNBC this week said scientists

reviewing the drugs had made the decision, not him.

Shares of Replimune ( REPL ) closed nearly 22% higher on

Friday, after news of Makary's likely ouster. BMO analyst Evan

Seigerman said firing Makary would be a positive for BioPharma,

with expectations that any replacement would focus on stability

and predictability for the industry.

Makary has also found himself in the middle of the abortion pill

battle, facing growing pressure to produce a safety review he

promised last year. Susan B. Anthony Pro-Life America President

Marjorie Dannenfelser renewed her call this week to terminate

Makary, saying his indifference was unacceptable to millions of

anti-abortion voters.

Anti-abortion activists met with White House officials on Friday

amid their growing frustration.

Trump was also angered by Makary's handling of flavored

e-cigarettes, a product he had pledged to protect during his

2024 campaign, with the Wall Street Journal reporting that Trump

rebuked his FDA chief over the weekend for not approving them

more quickly.

FINDING A REPLACEMENT

The White House is considering naming FDA Deputy Commissioner

Kyle Diamantas, who heads the agency's food group, as acting

commissioner, according to one of the sources and an additional

source.

Potential names under consideration as the actual nominee to

run the agency include former FDA Commissioner Stephen Hahn and

former Acting Commissioner and Assistant Health Secretary Brett

Giroir, according to those two sources and a third source.

EXODUS OF EXPERIENCED REGULATORS

The agency under Kennedy and Makary has been mired in

high-profile departures, feuds between top leaders, accusations

of politicization and low morale. It has lost thousands of

employees to layoffs and resignations and cycled through five

directors of its drug center since January last year.

Biologics officials Peter Marks and Rachael Anatol, and drug

evaluation figures Richard Pazdur and Jacqueline Corrigan-Curay

were among the departed senior regulators.

Vinay Prasad, ousted as biologics division director last July

only to be reinstated two weeks later, was recently involved in

controversial rare-disease treatment decisions before his final

departure last month.

Former FDA Chief Scientist Jesse Goodman said a new

commissioner would need to rebuild the top leadership, with both

of the FDA's divisions that regulate drugs currently headed by

acting directors.

"There is a vacuum that has created a lot of gaps in

expertise and experience," Goodman said.

Makary's departure would add to a series of leading

officials who have left agencies within the Department of Health

and Human Services, including top leaders at the Centers for

Disease Control and Prevention, the National Institutes of

Health and others.

A surgical oncologist at the Johns Hopkins University School of

Medicine, Makary was confirmed as FDA commissioner last March.

He wrote best-selling books on healthcare costs and what he

described as modern medicine's failures, and has been one of the

key advocates of the Make America Healthy Again movement backed

by Kennedy.