Naomi Osaka defeats Coco Gauff at the US Open to reach her first major quarterfinal since 2021

NEW YORK (AP) — Naomi Osaka smiled before her U.S. Open showdown against Coco Gauff began Monday — and after it ended. Between points, Osaka patted her left thigh and quietly told herself, almost in a whisper: “Come on. Come on.”

Once the ball was in play, Osaka's strokes were loud and on-target, producing the sort of confident, consistent and power-swinging tennis that carried her to four Grand Slam titles and the No. 1 ranking.

In the biggest statement yet that she is back at the height of her game, and again a serious contender for the sport's highest honors, Osaka eliminated Gauff 6-3, 6-2 in Arthur Ashe Stadium to reach her first major quarterfinal in more than 4 1/2 years.

“This is kind of unchartered territory at this point of my career,” said Osaka, a 27-year-old who was born in Japan and moved to the U.S. with her family at age 3. “I’m just enjoying it. I’m having fun. I’m being able to play against the best players in the world.”

The No. 23-seeded Osaka was better throughout than No. 3 Gauff, whose repeated mistakes during a tournament that's been a near-constant struggle for her really made the difference. And Gauff's body language was quite a contrast to Osaka's. Gauff repeatedly would put her palms up or cover her face with a hand or gesture toward her team in the stands, looking confused or upset.

Still, Gauff vowed afterward: “I am not going to let this crush me.”

On Wednesday, Osaka will face No. 11 Karolina Muchova of the Czech Republic for a berth in the semifinals. Muchova, the 2023 French Open runner-up and a semifinalist in New York the past two years, advanced with a 6-3, 6-7 (0), 6-3 victory No. 27 Marta Kostyuk of Ukraine.

It was Muchova who got past 45-year-old Venus Williams in three sets in the first round of this U.S. Open. Muchova also beat Osaka in the second round at Flushing Meadows in 2024.

Against Gauff, Osaka displayed the demeanor — and, importantly, the booming serve and other strokes — that carried her to hard-court Slam championships at the U.S. Open in 2018 and 2020, and at the Australian Open in 2019 and 2021.

It was at the French Open later in 2021 that Osaka helped spark a global conversation about mental health by revealing she felt anxiety and depression. She then took a series of breaks from the tour.

That most recent trophy at Melbourne Park was the last time Osaka had even made it as far as the fourth round at any major until this match against Gauff, a 21-year-old from Florida who owns two major trophies. The first came at Flushing Meadows in 2023 and the second at the French Open this June.

Osaka returned to the tour last season after a 17-month maternity leave. Her child, Shai, was born in July 2023.

“I’m a little sensitive, and I don’t want to cry, but, honestly, I just had so much fun out here," said Osaka, who first played Gauff back at the 2019 U.S. Open, also in Ashe, and won that one, too.

“I was in the stands like two months after I gave birth to my daughter, watching Coco. I just really wanted an opportunity to come out here and play,” Osaka told the crowd. "This is my favorite court in the world, and it means so much for me to be back here.”

Gauff came out jittery at the start. Her problematic serve was fine; other strokes were the problem. She finished with 33 unforced errors — way more than Osaka’s 12.

Plus, Osaka's serving and returning were terrific. She won 32 of the 38 points she served — 15 of 16 when first serves landed in — and never faced a single break point. She also converted all four break chances she earned.

“She forced me to earn every point out there today,” Gauff acknowledged.

A key: Osaka used her forehand, her best stroke, to go after Gauff’s forehand, her worst.

By the end of the first set, Gauff had made 16 unforced errors and Osaka only five. By the end of the match, 20 of Gauff’s unforced errors were off the forehand side.

“After the match, I was really disappointed. Kind of broke down to my team,” Gauff said. “Then, hearing their perspectives and everything, it definitely is a lot of positive things.”

Karolina Muchova, of the Czech Republic, returns a shot against Marta Kostyuk, of the Ukraine, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Heather Khalifa)

Naomi Osaka, of Japan, celebrates after winning a match against Coco Gauff, of the United States, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Coco Gauff, of the United States, leaves the court after losing a match against Naomi Osaka, of Japan, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Naomi Osaka, left, of Japan, greets Coco Gauff, of the United States, after their match in the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Naomi Osaka, of Japan, celebrates after winning a match against Coco Gauff, of the United States, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Coco Gauff, of the United States, reacts during a match against Naomi Osaka, of Japan, in the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Naomi Osaka, of Japan, reacts during a match against Coco Gauff, of the United States, in the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Naomi Osaka, of Japan, returns a shot against Coco Gauff, of the United States, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Coco Gauff, of the United States, reacts during a match against Naomi Osaka, of Japan, during the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

Naomi Osaka, of Japan, reacts during her match against Coco Gauff, of the United States, in the fourth round of the US Open tennis championships, Monday, Sept. 1, 2025, in New York. (AP Photo/Kirsty Wigglesworth)

FILE - Coco Gauff wipes away tears while talking to Naomi Osaka, of Japan, after Osaka defeated Gauff during the third round of the U.S. Open tennis tournament Saturday, Aug. 31, 2019, in New York. (AP Photo/Adam Hunger, File)

Naomi Osaka, of Japan, reacts after scoring a point against Hailey Baptiste, of the United States, during the second round of the U.S. Open tennis championships, Thursday, Aug. 28, 2025, in New York. (AP Photo/Yuki Iwamura)

Coco Gauff, of the United States, reacts to defeating Donna Vekic, of Croatia, during the second round of the U.S. Open tennis championships, Thursday, Aug. 28, 2025, in New York. (AP Photo/Frank Franklin II)

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical and scientific standards long used to vet the safety and effectiveness of new medicines.

Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts and leadership upheavals, according to seven current or recently departed staffers. The people spoke to The Associated Press on the condition of anonymity because they were not authorized to discuss confidential agency matters.

At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner’s National Priority Voucher program, which promises approval in as little as one month for medicines that support “U.S. national interests.”

Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agency’s political appointees and senior leaders.

But drug reviewers say they've received little information about the new program's workings. And some staffers working on a highly anticipated anti-obesity pill were recently told they can skip certain regulatory steps to meet top officials' aggressive deadlines.

Outside experts point out that FDA drug reviews — which range from six to 10 months — are already the fastest in the world.

“The concept of doing a review in one to two months just does not have scientific precedent,” said Dr. Aaron Kesselheim, a professor at Harvard Medical School. “FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn’t have the resources to do it.”

On Thursday Reuters reported that FDA officials have delayed the review of two drugs in the program, in part due to safety concerns, including the death of a patient taking one of the medications.

Health and Human Services spokesman Andrew Nixon said the voucher program prioritizes “gold standard scientific review” and aims to deliver “meaningful and effective treatments and cures."

The program remains popular at the White House, where pricing concessions announced by the Republican president have repeatedly been accompanied by FDA vouchers for drugmakers that agree to cut their prices.

For instance, when the White House announced that Eli Lilly and Novo Nordisk would reduce prices on their popular obesity drugs, FDA staffers had to scramble to vet new vouchers for both companies in time for Trump's news conference, according to multiple people involved in the process.

That’s sparked widespread concern that FDA drug reviews — long pegged to objective standards and procedures — have become open to political interference.

“It’s extraordinary to have such an opaque application process, one that is obviously susceptible to politicization,” said Paul Kim, a former FDA attorney who now works with pharmaceutical clients.

Many of the concerns around the program stem from the fact that it hasn't been laid out in federal rules and regulations.

The FDA already has more than a half-dozen programs intended to speed up or streamline reviews for promising drugs — all approved by Congress, with regulations written by agency staff.

In contrast, information about the voucher program is mostly confined to an agency website. Drugmakers can apply by submitting a 350-word “statement of interest.”

Increasingly, agency leaders such as Dr. Vinay Prasad, the FDA’s top medical officer and vaccine center director, have been contacting drugmakers directly about awarding vouchers. That’s created quandaries for FDA staffers on even basic questions, such as how to formally award a voucher to a company that didn’t request one.

Nixon, the HHS spokesman, said that voucher submissions are evaluated by “a senior, multidisciplinary review committee,” led by Prasad.

Questions about the legality of the program led the FDA’s then-drug director, Dr. George Tidmarsh, to decline to sign off on approvals under the pathway, according to several people with direct knowledge of the matter. Tidmarsh resigned from the agency in November after a lawsuit challenging his conduct on issues unrelated to the voucher program.

After his departure, Sara Brenner, the FDA’s principal deputy commissioner, was set to have the power to decide, but she also declined the role after looking further into the legal implications, according to the people. Currently the agency’s deputy chief medical officer, Dr. Mallika Mundkur, who works under Prasad, is taking on the responsibility.

Giving final approval to a drug carries significant legal risks, essentially certifying that the medicine meets FDA standards for safety and effectiveness. If unexpected safety problems later emerge, both the agency and individual staffers could be pulled into investigations or lawsuits.

Traditionally, approval comes from FDA drug office directors, made in consultation with a team of reviewers. Under the voucher program, approval comes through a committee vote by senior agency leaders led by Prasad, according to multiple people familiar with the process. Staff reviewers don't get a vote.

“It is a complete reversal from the normal review process, which is traditionally led by the scientists who are the ones immersed in the data,” said Kesselheim, who is a lawyer and a medical researcher.

Not everyone sees problems with the program. Dan Troy, the FDA’s top lawyer under President George W. Bush, a Republican, says federal law gives the commissioner broad discretion to reorganize the handling of drug reviews.

Still, he says, the voucher program, like many of Makary’s initiatives, may be short-lived because it isn't codified.

“If you live by the press release then you die by the press release,” Troy said. “Anything that they’re doing now could be wiped out in a moment by the next administration.”

Initially framed as a pilot program of no more than five drugs, it has expanded to 18 vouchers awarded, with more under consideration. That puts extra pressure on the agency’s drug center, where 20% of the staff has left through retirements, buyouts or resignations over the past year.

When Makary unveiled the program in October there were immediate concerns about the unprecedented power he would have in deciding which companies benefit.

Makary then said that nominations for drugs would come from career staffers. Indeed, some of the early drugs were recommended by FDA reviewers, according to two people familiar with the process. They said FDA staffers deliberately selected drugs that could be vetted quickly.

But, increasingly, selection decisions are led by Prasad or other senior officials, sometimes unbeknownst to FDA staff, according to three people. In one case, FDA reviewers learned from GlaxoSmithKline representatives that Prasad had contacted the company about a voucher.

Access to Makary is limited because he does not use a government email account to do business, according to people familiar with the matter, breaking with longstanding precedent.

Once a voucher is awarded, some drugmakers have their own interpretation of the review timeline — creating further confusion and anxiety among staff.

Two people involved in the ongoing review of Eli Lilly's anti-obesity pill said company executives initially told the FDA they expected the drug approved within two months.

The timeline alarmed FDA reviewers because it did not include the agency's standard 60-day prefiling period, when staffers check the application to ensure it isn’t missing essential information. That 60-day window has been in place for more than 30 years.

Lilly pushed for a quicker filing turnaround, demanding one week. Eventually the agency and the company agreed to a two-week period.

Nixon declined to comment on the specifics of Lilly's review but said FDA reviewers can “adjust timelines as needed.”

Staffers were pushed to keep the application moving forward, even though key pieces of data about the drug's chemistry appeared to be missing, according to one person involved in the process. When reviewers raised concerns about some of the gaps during an internal meeting, the person said, they were told by a senior official: “If the science is sound then you can overlook the regulations.”

Former reviewers and outside experts say that approach is the opposite of how FDA reviews should work: By following the regulations, staffers scientifically confirm the safety and effectiveness of drugs.

Skipping review steps could also carry risks for drugmakers if future FDA leaders decide a drug wasn’t properly vetted. Like other experts, Kesselheim says the program may not last beyond the current administration.

“They are fundamentally changing the application of the standards, but the underlying law remains what it is,” he said. “The hope is that one day we will return to these scientifically sound, legally sound principles.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks during a press briefing at the White House, Wednesday, Jan. 7, 2026, in Washington. (AP Photo/Jacquelyn Martin)