House lawmaker raises new concerns over FDA's ultra-fast drug review program

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House lawmaker raises new concerns over FDA's ultra-fast drug review program

2026-02-04 01:31 Last Updated At：01:40

WASHINGTON (AP) — A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials involved in the effort are complying with federal ethics rules.

In a letter sent Tuesday, Rep. Jake Auchincloss of Massachusetts took issue with the agency’s handling of the program and questioned its legal underpinnings, noting that Congress did not sign off on the plan.

The new scrutiny comes as the FDA is scheduled to hold an employee town hall Tuesday afternoon on the Commissioner’s National Priority Voucher program, according to three agency staffers who spoke to The Associated Press on condition of anonymity to discuss confidential agency matters.

Under the voucher program, drugmakers are promised expedited reviews of one to two months for new medicines that support “ national interests.” It’s at the center of FDA Commissioner Marty Makary’s stated goal of “cutting red tape” and “challenging assumptions” at the agency.

But the effort has become a flashpoint for controversy outside and inside the agency, with several senior staffers declining to sign off on drug approvals going through the program, as previously reported by the AP.

“The public must have transparency about the ‘voucher’ program, under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership,” states Auchincloss, who is a member of a House subcommittee on health.

Auchincloss asserts that the FDA has failed to publish or disclose financial disclosure forms for eight senior FDA officials who vote on which drugs should receive priority vouchers. Membership of group, which was first reported by Stat News, is mostly comprised of officials closely aligned with Health Secretary Robert F. Kennedy Jr., including Deputy FDA Commissioner Dr. Sara Brenner, Dr. Vinay Prasad, who oversees vaccines, and Dr. Tracy Beth Hoeg, FDA’s drug center director.

The forms, which are collected annually by the Office of Government Ethics, list investments, outside income and other financial details for senior government officials and their spouses. Such disclosures are considered critical to avoiding potential conflicts of interest at the FDA, where staffers are often involved in regulating multibillion-dollar, publicly traded companies.

A Department of Health and Human Services spokesperson didn't immediately respond to AP's questions about the letter.

Elsewhere in his letter, Auchincloss questions whether the FDA had the legal authority to establish the voucher program without action from Congress, which typically legislates such programs into law. His letter states that the FDA's legal office “was not consulted nor provided findings to support the agency’s claim,” that it could independently establish the program.

Auchincloss also notes that FDA officials did not respond to two letters he sent last year requesting information. In the new letter, the lawmaker instructs the agency to “affirm or refute,” his findings.

In November, Sen. Bernie Sanders of Vermont and Rep. Frank Pallone of New Jersey sent a letter seeking answers to 15 questions about the FDA’s voucher program. Pallone is the top Democrat on the House Energy and Commerce Committee, which oversees health agencies.

The agency did not respond to the letter, according to a committee staffer.

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.

Lindsey Vonn is 'confident' she can race at Olympics despite ruptured ACL in left knee

CORTINA D'AMPEZZO, Italy (AP) — Lindsey Vonn is “confident” she can compete at the upcoming Milan Cortina Winter Olympics with a torn ACL from a crash four days ago.

Vonn said on Tuesday the damage to her left knee was a “completely ruptured” ACL, bone bruising “plus meniscal damage.”

After three days of physical therapy and doctors' advice, Vonn tried skiing on Tuesday. She did not appear to be limping as she entered and exited a news conference.

“My knee is not swollen, and with the help of a knee brace, I am confident that I can compete on Sunday," Vonn said.

“So this is not obviously what I had hoped for. I know what my chances were before the crash and I know my chances aren’t the same as it stands today but I know there’s still a chance. And as long as there’s a chance, I will try.

“I will do everything in my power to be in the starting gate."

Vonn crashed in a World Cup downhill in Crans-Montana, Switzerland on Friday and ended up in the safety nets. After skiing to the bottom of the course she was taken to hospital.

The 41-year-old American was expected to be one of the biggest stars of the Winter Games, which start Friday with the opening ceremony. Her first race comes two days later in the women’s downhill. Vonn also plans on competing in super-G and the new team combined event.

The opening women’s downhill training session is scheduled for Thursday.

Teammate Bella Wright said Vonn has what it takes — a strong mental state — to ski through her injuries.

“If anyone can do it, it’s Lindsey,” Wright said.

Breezy Johnson, the downhill and combined world champion, was in a similar situation to Vonn at Cortina during a World Cup weekend in 2022.

“I’ve tried and failed to ski this course with no ACL and that doesn’t mean that she can’t do it,” Johnson said. “There are more athletes that ski without ACLs and with knee damage than what we talk about.”

Andrea Panzeri, the chief physician for the Italian Winter Sports Federation, said numerous athletes have competed at elite level with a torn ACL and other severe knee issues.

Vonn’s fellow downhiller Sofia Goggia came back to win a silver medal at the 2022 Olympics weeks after spraining her left knee, partially tearing her ACL and suffering a “minor fracture” of the fibula bone in her leg — plus some tendon damage.

Italian freetsyle skier Flora Tabanelli tore the ACL in her right knee in November but put off surgery until after the Olympics.

Tabanelli is 18, though.

“But (Vonn) has experience, the physical ability and the experience on this course,” Panzeri said. “If she decides to try and race, it’s because her clinical condition and her doctors are allowing her to. She doesn’t have anything to lose. I think it’s worth a try.”

Vonn has had numerous crashes and injuries in her career. One of her worst was at the 2013 world championships in Schladming, Austria during a super-G that was also held in difficult conditions.

Vonn tore her right knee. She returned the following season, got hurt again and missed the 2014 Sochi Olympics.

She was also battered up before the 2019 world championships but took bronze in downhill before going into a nearly six-year retirement.

“I’ve been in this position before. I know how to handle it,” Vonn said. “I feel a lot better now than I did in 2019 . . . And I still got a medal there with no LCL and three tibial plateau fractures. So, like I said, this is not an unknown for me. I’ve done this before.”

Still, Vonn added, “This would be the best comeback I’ve done so far. Definitely the most dramatic.”

Vonn made a stunning comeback last season after nearly six years away. Skiing with a partial titanium implant in her right knee, she has been the circuit’s leading downhiller this season with two victories and three other podium finishes in five races.

Including super-G, Vonn completed eight World Cup races and finished on the podium in seven of them. Her worst finish was fourth.

Women’s skiing during the Games will be in Cortina, where Vonn holds the World Cup record with 12 wins.

She has won three Olympic medals: Gold in downhill and bronze in super-G in 2010 and bronze in downhill in 2018.

It hasn’t just been about recovery for Vonn these past few days.

On her way to Cortina, she stopped at the grave of her childhood coach Erich Sailer, who died in August aged 99.

Sailer coached Vonn at Buck Hill in Minnesota. He’s buried just outside Innsbruck, Austria.

Vonn said she shed some tears during the graveside visit – the only tears she’s shed these past few days.

“I miss him. And I know exactly what he would say to me right now. And it definitely gives me additional hope that I know that he would support me,” Vonn added.

“He would say, ‘It’s only 90 seconds. What’s 90 seconds in a lifetime? It’s nothing. You can do it.’” Vonn said. “That’s what he said to me before my last run in Are, and I know he would say it to me again today.”

Associated Press writer Jennifer McDermott contributed.

AP Olympics: https://apnews.com/hub/milan-cortina-2026-winter-olympics