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While FDA is implementing new accelerated approval reforms, Kaiser Permanente says the reforms do not go far enough. The health system, which owns an insurer , said the agency needs to work with Congress this year on new laws that crack down on biopharma companies that don’t complete confirmatory trials. The comments from Kaiser and others are on new FDA draft guidance on accelerated approvals. The intent is to give the FDA a newly strengthened ability to ensure post-approval studies are up and running prior to approval and streamline the agency’s authority to withdraw accelerated approvals. “Although these reforms are a step in the right direction, we believe Congress must go further by statutorily requiring post-approval studies for all products approved through the accelerated approval pathway using surrogate endpoints and considering specific consequences for manufacturers who fail to complete them,” Anthony Barrueta, SVP of government relations at Kaiser, wrote in comments to FDA that were released earlier this month. The agency in December and January released new draft guidance offering more specifics on its expedited withdrawals of new accelerated approvals and how if a confirmatory trial isn’t underway before an accelerated approval, the FDA won’t clear the drug for use. While the FDA currently offers a table of surrogate endpoints that companies have historically relied on for accelerated approvals, Barrueta calls on the FDA to create a publicly available record of successful surrogate and clinical endpoints and their corresponding clinical benefits by indication, “with the evidence base underlying each of those measures.” The left-leaning philanthropy Arnold Ventures raised similar concerns in its comment to FDA, noting “the lack of clear standards for how surrogate endpoints are chosen and in which specific cases they are appropriate.” The comments come as CMS denied coverage for Biogen’s first Alzheimer’s drug Aduhelm in 2022, following an unexpected accelerated approval from the FDA. That coverage denial led to broader questions on if insurers might take a harder look at accelerated approvals. “The accelerated approval program’s current weaknesses deprive physicians, patients, and other stakeholders of vital evidence that can help improve outcomes and avoid paying for ineffective therapies,” Barrueta wrote in his comment. In its comment, Harvard Medical School’s Program On Regulation, Therapeutics, And Law also called for alerts when confirmatory studies are delayed, unpublished or negative, as well as additional benefit-risk reviews to align with the European Medicines Agency’s standards for its conditional approval pathway. Italy-based Chiesi Farmaceutici is the only pharma company to comment on the draft guidance so far, calling on the FDA to describe how the agency may account for the patient and caregiver experience when it comes to confirmatory trials. Chiesi also notes the unintended consequences of provisional accelerated approval qualifications, noting that it recently filed an application for a drug for a rare disease with one available therapy approved under the accelerated pathway 18 years prior. Chiesi’s priority review action date was extended by four months by the FDA, “and during that time the other product approval was converted to a ‘traditional’ approval. As a result, Chiesi’s product was blocked from an accelerated approval just prior to the action date.”

Through a contentious three-and-a-half-hour hearing, Robert F. Kennedy Jr. emerged relatively unscathed as the Senate considers his nomination for HHS secretary. Democratic senators grilled Kennedy over his history of controversial statements on vaccines. But the hearing brought no revelations or gotcha moments for Kennedy, who attempted to sidestep on issues like abortion that might create problems with Republican lawmakers. At other times, his command of policy details — or even his own past comments — seemed weak. He often spoke in generalities about health policy reforms, occasionally getting basic facts wrong, such as referring to Medicaid’s high premiums at least twice. (Most Medicaid recipients don’t pay premiums.) Kennedy is seen as one of Trump’s most controversial Cabinet picks, with senators expected to vote largely along party lines. Republicans control 53 of 100 seats in the Senate, meaning Kennedy can afford up to three GOP defections and still win confirmation, assuming a tie-breaking vote in his favor. The hearing also touched on some of Kennedy’s more fringe positions, from asking for his thoughts on affiliated organizations selling “unvaxxed, unafraid” baby onesies, to his previous comments on the possibility of Lyme disease coming from a bioengineered virus, to comparing the CDC’s actions to “Nazi death camps.” Next up is a hearing with the Senate Health, Education, Labor, and Pensions Committee on Thursday, and an eventual vote ( likely next week ) on the finance committee that would advance his nomination to the full Senate. Read below for full updates from Wednesday’s hearing: . . . . . Kennedy describes ‘good science,’ puts amyloid hypothesis in the crosshairs (1:20pm ET): Biogen, Eisai and Lilly, look away. Kennedy elaborated on what he means by “good science,” a frequent bullet point in his quest to make regulatory decisions more transparent. He told Sen. Todd Young (R-IN) that the gold standard of science “means real scientific research with replication of studies,” which he contends the NIH is not doing. He used research into the amyloid plaque hypothesis as an example, alleging that the NIH has shut down additional research into the root cause of Alzheimer’s after one study into the amyloid theory. Wiping out amyloid plaque buildup was the mechanism for Biogen’s first and more controversial Alzheimer’s drug Aduhelm, which won FDA approval but was virtually discarded by CMS over a clear efficacy signal. But two newer Alzheimer’s drugs, Leqembi and Kisunla, are based on the same hypothesis and showed more promising Phase 3 clinical data en route to approval. Leqembi was developed by Eisai and Biogen, while Kisunla was made by Lilly. The drugmakers have also been assessing other mechanisms, like the buildup of a similar tau protein, in other clinical-stage candidates. Kennedy also pledged “radical transparency for raw data,” but didn’t explain what specific data he would release as HHS secretary. Any data submitted by biopharma companies to the FDA is considered commercially confidential and cannot be released publicly. — Max Bayer and Zach Brennan . . . . . ‘Nazi death camps’ comment (1:05pm ET): One thing there’s been a lot of is Democrats just reading Kennedy’s own words to him and asking him if he still believes them. Take this interaction with Sen. Raphael Warnock (D-GA), who asked Kennedy if he compared the CDC to “Nazi death camps.” Kennedy: “I don’t believe I ever compared the CDC to Nazi death camps … I never said it.” Warnock: “Actually I have a transcript.” Kennedy said that he was “not comparing the CDC to Nazi death camps. I was comparing the injury rate to our children to other atrocities” and that “to the extent it’s been interpreted that way, I don’t agree with that.” A lot of Kennedy’s own words are probably a more effective line of argument than lawmakers’ own attacks. Again, we’ll see if it matters. — Drew Armstrong . . . . . What hasn’t Kennedy been asked? (1pm ET): Lots of hot-button issues, actually. Like: — Zachary Brennan . . . . . Relatively smooth sailing (12:50pm ET): The committee is back from a brief break, so let’s take stock. Democrats came in wanting to highlight Kennedy’s views that could flip a handful of votes. There were no major reveals up their sleeves. They elevated some of his more fringe statements on topics from HIV to bioengineered viruses to vaccines, but there were no revelatory moments. While not dramatic, there have been several instances where Kennedy was asked for specific policy ideas on topics like Medicare, Medicaid, and PBMs, but reverted to generalities. Whether that will make a difference remains to be seen, but right now it’s hard to point to a moment where Democrats landed anything that might change a vote by a Republican like Tillis. Still, the margins in the Senate are tight. Kennedy can afford to lose three Republican votes, assuming Democrats are unanimous in their opposition. — Andrew Dunn . . . . . Kennedy backs PBM reform, has few details (12:45pm ET): The nominee told Sen. Maria Cantwell (D-WA) that he supports bipartisan legislation to rein in PBMs “in principle.” But he said he had not read the exact legislation out of the Senate. It follows a trend of Kennedy not elaborating on health policy specifics that some senators have picked at. Sen. Chuck Grassley (R-IA) also brought up PBM reform earlier in the hearing, saying that “I expect you to work with us to hold PBMs accountable.” PBM reforms were included in a House spending bill that was ultimately spiked by Trump allies in December, like Elon Musk, who demanded slimmed-down legislation. — Max Bayer . . . . . FDA has made it clear abortion drug is safe (12:40pm ET): Several Republican senators like James Lankford brought up the idea of reviewing the safety of the abortion pill mifepristone, which Kennedy said Trump is interested in. But the FDA has made clear over the years that mifepristone is safe when used as indicated and directed. First approved two decades ago, the agency noted that Mifeprex (the brand name version of mifepristone) has extensive scientific evidence showing it’s safe and effective. “The FDA’s periodic reviews of the postmarketing data for Mifeprex and its approved generic have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days gestation,” the agency said. — Zachary Brennan . . . . . Drug pricing unity with Bernie (12:25pm ET): Kennedy appeared to agree with Sen. Bernie Sanders (I-VT) on tying US drug prices to international markets. Sanders said he plans to introduce a bill on that topic. The discussion was vague, but both mentioned the US paying 10 times more for certain drugs than Europe. “I think in principle we can, we should end that disparity,” Kennedy said, before Sanders moved onto other topics. — Andrew Dunn . . . . . Is this a winning tactic? (12:23pm ET): Some of the members on the Democratic side, notably Bernie Sanders (I-VT) and Catherine Cortez Masto (D-NV), appear to be trying to bring up Kennedy’s Democratic positions on abortion and climate change as a way to remind Republicans that Kennedy may not believe what they believe. It’s not clear how successful that strategy will be. Republicans know who Kennedy is, and Trump’s choice of Kennedy would seem to indicate that if Trump is OK with those past positions, the rest of Republicans can be, too. — Drew Armstrong . . . . . Tillis sounds like he’s on board (12:20pm ET): Thom Tillis (R-NC) was seen as an undecided Republican senator entering this hearing. His line of questioning suggests he’s not. Tillis gave Kennedy the opportunity to reject the assessment that he’s a conspiracy theorist and to commit to not interjecting in a future Warp Speed-like project, should one arise. — Max Bayer . . . . . Warren zeroes in on financial conflicts (12:15pm ET): Sen. Elizabeth Warren (D-MA) started her time with what she called an “easy question” for Kennedy: “Will you commit that when you leave this job you will not accept compensation from a drug company, a medical device company, a hospital system, or a health insurer for at least four years, including as a lobbyist or a board member?” After asking Warren to repeat the question, Kennedy said, with a smile, “I’m happy to commit to that.” Kennedy later quipped: “I don’t think any of them want to give me money, by the way.” But Kennedy was much less amenable to not receiving fees related to his work suing vaccine makers, which has included Merck’s HPV vaccine, Gardasil. Warren tried to hit on his potential conflicts of interest regulating the same industry he has profited off suing. Kennedy responded that he would not commit to not suing drugmakers, which received a slight applause from the audience. “No one should be fooled here,” Warren said. “Kennedy can kill off access to vaccines and make millions of dollars while he does it.” — Max Bayer . . . . . The future of the IRA under Trump (11:55am ET): Kennedy was asked about how he would approach drug price negotiations, a key issue for the pharma industry. “President Trump was very aggressive during his first term about negotiating drug prices and he has instructed me and I have met with him that we need lower prices,” Kennedy told the committee. Exactly how the government will implement those negotiations is a key issue for the pharma industry. But after Kennedy’s initial comment, the topic quickly got sidetracked over another debate about how much independence Kennedy would have. (Earlier today, CMS made some of its first public comments about how it would conduct negotiations.) — Drew Armstrong . . . . . A mifepristone dodge (11:38am ET): After agreeing to a Montana trip during ski or hunting season, Sen. Steve Daines (R-MT) turned his attention to the abortion pill mifepristone. Kennedy responded with few specifics on his views of the drug, largely deferring to Trump: “President Trump has asked me to study the safety of mifepristone,” Kennedy said. “He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies, and I will work with this committee [to] make those policies make sense.” Sen. James Lankford (R-OK) similarly took aim at the Biden administration’s loosening of mifepristone dispensing rules and alleged that the FDA was not tracking adverse events of the drug. He asked Kennedy if the FDA will “move to be able to actually give transparency to the American people, and to say this drug is no different than any other drug.” Kennedy responded: “We need to know what the adverse events are.” The questions come after former Vice President Mike Pence has lobbied conservative senators to vote against Kennedy because of his previous stances on abortion. — Andrew Dunn and Max Bayer . . . . . Tensions rise after Bennet briefly aligns with Kennedy (11:15am ET): Sen. Michael Bennet (D-CO) seemed to give Kennedy a bit of credit for his pursuit in tackling obesity and mental health conditions. It was in-line with what fellow Colorado Democrat, Gov. Jared Polis, tweeted the night of Kennedy’s nomination. That brief alignment didn’t last long. Bennet started to take Kennedy to task over past statements he’s made. On Covid-19 being engineered to target black and white people but spare Ashkenazi Jews and Chinese people, Kennedy said he was citing an NIH study. On Lyme disease being a military bioweapon, Kennedy acknowledged he probably said that. Kennedy then tried to rebut a statement on abortion. Bennet raised his voice during this exchange, saying he wanted “all of our colleagues to hear it.” The job is “too important for the games that you’re playing. Mr. Kennedy,” Bennet said. “It doesn’t matter what you come here and say that isn’t true, that’s not reflective of what you really believe.” — Max Bayer . . . . . Kennedy and Wyden spar over measles, polio vaccines (10:47am ET): Wyden asked Kennedy whether measles was a deadly disease. Kennedy didn’t answer directly, referring to the death rate before the vaccine was introduced in the 60s. That led to a louder back and forth: Kennedy: “I support the measles vaccine. I support the polio vaccine. I will do nothing as HHS secretary, that makes it difficult or discourages people from taking…” Wyden: “Anybody who believes that ought to look at the measles book you wrote saying parents have been misled into believing that measles is a deadly disease.” Kennedy:  “That’s not true.” In a previous podcast interview, Kennedy alleged that the polio vaccine contained a virus that could be associated with soft-tissue cancers. He said then that if he was asked whether the vaccine prevented more deaths than it caused, he said he’d respond, “I don’t know, because we don’t have the data on that.” — Max Bayer . . . . . Republicans lean into food and health; Democrats lean into vaccines (10:37am ET): The opening questions from the committee are painting a picture of how this hearing may go. Finance Chairman Mike Crapo focused on chronic disease and food issues, which are far less controversial and have generated some degree of agreement across the aisle. Ranking member Ron Wyden is going right after Kennedy on his anti-vaccine views, showing the Democratic strategy of trying to paint Kennedy as an extremist. — Drew Armstrong . . . . . A brief interruption (10:29am ET): The hearing had its first interruption, as a protester shouted out during Kennedy’s opening statement. As he began to state he is not anti-vaccine, they appeared to yell “You lie” or “You are” before being escorted out of the room. — Andrew Dunn . . . . . What we’re looking for over the next few hours (10:25am ET): A lot of these Senate hearings are theater, given how much happens in meetings with lawmakers, the media and in the committee’s own review ahead of the hearing itself. But with a nominee like Kennedy, whose confirmation is still uncertain, and who holds a number of controversial positions on vaccines, abortion and science, they can certainly matter. Here’s what we’re watching closely for: The hearing is likely to be unpredictable. What will matter for his chances is whether his nomination emerges stronger, or weaker. — Drew Armstrong . . . . . Wyden comes out swinging (10:15am ET): In what’s likely to be a reflection of Democratic arguments in the hours ahead, Senate Finance Committee ranking member Ron Wyden (D-OR) said Kennedy “has embraced conspiracy theories, quacks, charlatans, especially when it comes to the safety and efficacy of vaccines.” Wyden criticized Kennedy’s involvement in a measles outbreak in Samoa and comments suggesting he’d be open to further restricting the abortion pill, mifepristone. Wyden said that Kennedy often counters criticisms by saying he is not making recommendations, “he’s just asking questions and giving people choices.” “It’s a slippery tactic to dodge any real responsibility for his words and actions, and it is, in my view, absurd coming from somebody who’s trying to win confirmation for a job that is entirely about making recommendations,” he said. — Max Bayer . . . . . Kennedy will claim he’s not anti-vaccine (9:55am ET) Kennedy is expected to say that “news reports have claimed that I am anti-vaccine or anti-industry. Well, I am neither; I am pro-safety,” according to reporting from Bloomberg and Fox News . “All of my kids are vaccinated, and I believe vaccines have a critical role in healthcare.” But those claims run counter to what he’s said in private in the past, and the “pro-safety” part may be misleading. Kennedy has yet to say what safety data he’s seeking, and vaccine experts have told Endpoints that Kennedy raising broad questions about safety and asking for more information may be a smokescreen to selectively make the data fit preexisting conclusions. — Zachary Brennan . . . . . RFK’s fate likely lies in the hands of a few (Jan. 29, 9:30am ET) : Most of the GOP senators are on board with Kennedy’s nomination, but there are a few to watch for in the next couple of days. Sen. Bill Cassidy (R-LA) on the finance committee, which will vote on whether to advance Kennedy’s nomination, has called Kennedy’s previously-stated positions on vaccines “wrong.” He has not yet stated how he’ll vote. Sen. Thom Tillis (R-NC) also appears undecided, and has been lobbied by North Carolina doctors to vote against Kennedy. Cassidy is also the chairman of the Senate Health Committee, which is holding a courtesy hearing for Kennedy on Thursday. Sens. Lisa Murkowski (R-AK) and Susan Collins (R-ME) are on the health committee as well, and have been moderate holdouts in a party that has largely coalesced around Trump’s agenda and cabinet picks. Murkowski, Collins, and Sen. Mitch McConnell (R-KY) all voted against the nomination of Defense Secretary Pete Hegseth. McConnell has been a supporter of the polio vaccines that Kennedy and his allies have scrutinized. — Max Bayer . . . . . Close vote is expected (Jan. 29, 9am ET): If Kennedy makes it out of the committee, the vote in the full Senate isn’t a lock. Republicans hold 53 of the Senate’s 100 seats. Democrats broadly oppose Kennedy’s nomination, so Trump’s nominee can only afford a few defections from the GOP. A simple majority will be needed. — Andrew Dunn . . . . . Kennedy’s cousin issues warning (Jan. 28, 2:30pm ET) : Caroline Kennedy called the HHS nominee a “predator” who’s “addicted to attention and power” in a letter to senators obtained by the Washington Post . The former US ambassador to Australia sent the letter ahead of the confirmation hearings. In it, she alleges that he discouraged vaccines for children while vaccinating his own kids, and that he encouraged family members to go down the path of substance abuse. — Alexis Kramer . . . . . Biopharma executives have split opinions on Kennedy (Jan. 28, 11:30am ET): Pharma leaders have ranged from full-on support to full-blown opposition ahead of the finance committee hearing. Los Angeles biotech billionaire Patrick Soon-Shiong says there’s a “completely different story” to Kennedy than his public portrayal as a controversial vaccine critic. George Yancopoulos, Regeneron’s chief scientific officer, said he likes people who will “challenge the status quo.” Meanwhile, former FDA chief and Pfizer board member Scott Gottlieb has been clear about his opposition. Read more from Andrew Dunn and Zachary Brennan.