Mifepristone

Martin Makary, M.D., said he would perform an independent assessment of the FDA’s staffing and their ability to perform, following recent White House-led layoffs affecting hundreds of probationary agency employees. \n Sitting before senators at his confirmation hearing to become commissioner of the FDA, Johns Hopkins surgeon and author Martin Makary, M.D., linked certain wearable technologies to the “Make America Healthy Again” movement pushed by the Trump administration and its health secretary, Robert F. Kennedy Jr.Makary also described the agency as having a “generational opportunity” to help people take care of their own health through the use of at-home treatments and tests.In particular, he pitched making continuous glucose monitors available to a wider population—saying that wearable blood sugar trackers may have the potential to help ward off chronic diseases such as obesity and diabetes before they become a diagnosis. “Why are we requiring continuous glucose monitors to have a doctor’s prescription, when it’s good for people to use these monitors and learn about what they’re eating?” Makary said to members of the Senate’s Health, Education, Labor and Pensions Committee.“We don’t want to limit continuous glucose monitoring to people with diabetes, we want to prevent diabetes, when 30% of our nation’s children have diabetes or prediabetes, or some form of early insulin resistance,” he added. “Why are we holding these tools to help people empower them with knowledge about their health until after they’re sick? Same with continuous blood pressure monitoring.”Last year, the FDA granted its first over-the-counter green lights to CGM systems, including Dexcom’s Stelo as well as Abbott’s Lingo and Libre Rio—which the companies have described as largely being aimed at a health-and-wellness market segment and curious consumers, as well as a cash-pay entry point for users with diabetes looking to try out a wearable sensor for the first time.Each are based on the designs of their makers’ respective prescription-only models, such as Dexcom’s G7 and Abbott’s Freestyle Libre, and perform similarly.However, the agency’s OTC clearances limit them to adults who are not taking insulin, a category that still includes millions of people in the U.S. with Type 2 diabetes. A prescription is required for devices that provide blood sugar data used to calculate insulin doses, either manually or through a connected automatic pump, such as for people with Type 1 diabetes.The FDA has also said that over-the-counter CGMs should not be used by people who face potentially dangerous low blood sugar levels, as they do not provide emergency hypoglycemia alerts.In its first clearance in March 2024, the agency described the move to make certain sensors prescription-free as an important step forward for health equity by moving care and wellness into the home setting.“Thanks to President Trump and Secretary Kennedy, for the first time we’re talking about root causes, both on a research basis and what we can do at every agency,” Makary said Thursday. “And, within the FDA, I think there are things we can do to help empower people by facilitating the independent scientific review of devices and other ways to prevent chronic diseases—with continuous glucose monitoring and continuous blood pressure monitoring and healthy foods for children.”Elsewhere during the hearing, Makary was asked about the possibility of tapping user fees collected from medical device companies to help fund post-market safety surveillance efforts—an option under the FDA’s drug and biologic regimes, but not at its device center, per the legislation packages passed by Congress every five years.“I’m a big believer in the idea that we should not turn a blind eye after the FDA approves something,” Makary said, specifically citing the addictions and harms caused by opioid painkillers. The current generation of medical device user fee legislation, known as MDUFA V, is up for renewal in late 2027. Makary was also repeatedly asked by senators on both sides of the aisle about the FDA’s recent cancellation of an annually scheduled meeting for its vaccine-focused advisory committee to discuss which influenza strains should be included in the inoculations for this fall and winter’s flu season.Makary refused to commit to immediately rescheduling the committee’s influenza meeting once confirmed and said the committee has in the past largely “rubber-stamped” the international consensus on the most dominant flu strains based on data from countries entering autumn in the Southern Hemisphere.Previously slated for March 13, the FDA\'s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, makes its recommendations months in advance because egg-based flu vaccines take months to manufacture in large quantities.He said that if appointed to the position, he would examine which topics need to be discussed and which do not—but did say that “the VRBPAC committee will be meeting if I’m confirmed and I’m commissioner,” though he did not specifically mention the meeting with influenza on its agenda.When asked about the current measles outbreak in Texas, where an unvaccinated child recently died, Makary said, “Vaccines save lives, and I believe that any child who dies of a vaccine-preventable illness is a tragedy in the modern era.”Makary was also asked for his views on the abortion pill mifepristone, with its availability for prescription via telehealth as well as its FDA approval as a whole having been the subject of recent legal challenges, following the Supreme Court’s 2022 overturning of Roe v. Wade.If confirmed, Makary said he would perform an assessment of the data the FDA has collected on mifepristone over the past two decades, in accordance with the agency’s risk mitigation policies. “I do believe in data, and I don’t believe in prejudging data,” he said, regarding whether he would find potential safety signals such as drug-drug interactions. In addition, Makary said he would perform an assessment of the FDA’s staffing and their ability to perform, following recent White House-led layoffs affecting hundreds of probationary agency employees.“I welcome input on inefficiencies at the agency, at the same time I want to make sure scientists and food inspectors and staff central to the core mission of the agency have all the resources they need to do their jobs well,” he said.When asked whether he would rescind last month’s terminations—including personnel funded by user fees and not by federal appropriations—he said he would review the layoffs but added that “if an employee has not logged onto their VPN in two years, then I don’t want to rehire that individual. But if there are people that deserve a look, of course then I’m happy to look at that.” Finally, Makary was asked about the Department of Government Efficiency (DOGE) and the General Services Administration listing earlier this week that it had terminated leases for 30 FDA facilities across 23 states and may be putting more up for sale.“Many of these are on the FDA’s White Oak campus in Maryland. One of these is a building called Building #1—and I was wondering if you were familiar with Building #1,” asked Democratic Maryland Sen. Angela Alsobrooks.“I’m not familiar with the numbering of the buildings, senator, I’m sorry,” Makary said.“Well, that’s where your office will be,” Alsobrooks replied.“Just pointing out that many of these decisions are arbitrary, and that they harm the work that we do and they harm the American people—and I just wanted to ask if you will be committed to making decisions that make sense and do not eliminate the FDA,” she added.“I believe in common sense and trusted science,” Makary said. “And, if confirmed, you have my commitment to do an assessment of personnel, to look at efficiencies—I welcome the input of any organization, of any individual member of Congress, from the administration, and from the DOGE team as well, to figure out how the government can be more efficient.”

The Senate hearing to consider President Donald Trump’s FDA nominee Marty Makary is off and running. Once again, it’s started with a number of hot-button issues, like access to abortion medications, US policy toward vaccines, and — inevitably — Covid-19. Democrats are pushing hard on how Makary would regulate access to the abortion pill mifepristone. In response, Makary has dodged a hard position and only said that he would collect and look at data. For years, that’s been an approach used by many nominees who have been pushed on abortion issues — say they have an open mind and promise to study the data. (White House politics, however, can sometimes interfere … ) He also fell into a heated exchange on another recent issue: the cancellation of an FDA vaccine advisory committee (VRBPAC) meeting on flu strains. That committee has become an early battleground over US vaccine policy, and the HHS under Secretary Robert F. Kennedy, Jr. has already taken steps that have worried science and vaccination advocates. Read below and refresh for live updates. . . . . . Sen. Lisa Blunt Rochester (D-DE): “Yes or no, do you believe clinical trial diversity is critically important?” (11:25am ET): “Well, if you’re talking about a trial of sickle cell disease, are we saying that we need to have white people in a trial of sickle cell?” Makary responded. Makary added: “I believe in common sense, and I believe in clinical trial diversity both, and so I believe if you’re going to make results extrapolated to the general population, you should have results in those populations that you’re making recommendations.” While less common, white people can have sickle cell disease, and have also participated in pivotal studies of sickle cell therapies. — Lei Lei Wu . . . . . Makary commits to using surgical experience when it comes to layoffs (11:20am ET): Sen. Tim Kaine (D-VA) questioned Makary on his thoughts on the nearly 1,000 “willy, nilly random” layoffs that have been made so far prior to Makary taking over as commissioner. Makary responded, “Look, I’m a surgeon, so you know, I’m going to give you a surgical answer.” Kaine noted that the decision to make these layoffs “is a little bit unusual,” particularly as the cuts have mostly come for probationary employees, many of whom are veterans. — Zachary Brennan . . . . . More on mifepristone (11:15am ET): Sen. Josh Hawley (R-MO) pressed Makary on whether he would reinstate the “two decades of in-person dispensing requirements” for mifepristone, which the Biden administration removed in 2021. He also asked if Makary would put back in place full reporting requirements for the drug, which the FDA relaxed in 2016. “I do think it makes sense to review the totality of data,” Makary reiterated. Makary throughout the hearing has repeatedly said he will look at the data. He told Hawley: “I don’t believe in pre-judging data before somebody has taken a look at it.” — Alexis Kramer . . . . . Smooth sailing for Makary so far (11am ET): Like yesterday’s hearing for NIH nominee Jay Bhattacharya, Makary appears to be making his way through the session with ease. His meetings with senators ahead of time don’t (yet) appear to have left any landmines, he’s sidestepping controversial issues and promising to study the data, and he’s not tied to any issues around Trump or Kennedy that could trip him up in a way that will matter for votes. It seems more likely that Democrats will save their fire for Trump’s CMS nominee, Mehmet Oz. Potential cuts to Medicaid have been a winning issues for Democrats and a chance to go after the administration and other Republicans on their plans. We’ll see where this goes over the next few hours, but if the tone stays like this, he seems like an easy vote. — Drew Armstrong . . . . . FDA pick pledges to speed biosimilar, generic drug approvals (10:55am ET): In response to questions from Sens. Susan Collins (R-ME) and Maggie Hassan (D-NH) on the potential for expediting biosimilar and generic drug approvals, Makary agreed that he would push to speed their approvals if confirmed as FDA commissioner. Collins said she previously introduced a bill that would create an expedited pathway for certain biosimilars, and Makary expressed interest in speeding these biologics competitors. — Zachary Brennan . . . . . Makary says he’ll assess FDA staffing (10:48am ET): When asked by Sen. Susan Collins (R-ME) about whether he will evaluate the Musk-led dismissal of hundreds of FDA staff, many of whose salaries were paid for by industry fees, Makary responded: “If confirmed as commissioner, you have my commitment that I will do an assessment of the staffing and personnel at the agency.” — Lei Lei Wu . . . . . Makary said he has ‘no preconceived plans’ on mifepristone (10:41am ET): When asked by Sen. Bill Cassidy (R-LA) whether he would reinstate an in-person dispensing requirement for mifepristone, Makary said he will “take a solid, hard look at the data.” “I can’t prejudge that data without looking at it,” he said later when pressed by Sen. Tammy Baldwin (D-WI) on maintaining current access to the abortion drug. Mifepristone has been on the market for decades and has been taken by millions of women. The FDA made changes in 2016 and 2021 that have removed the in-person dispensing requirement, among other changes. The Supreme Court last year unanimously rejected an attempt by doctors and anti-abortion groups to limit the use of mifepristone. Sen. Patty Murray (D-WA) told Makary that approvals for medication abortion and contraception products are based on “mountains of high-quality evidence,” and asked the nominee to commit to “upholding the science and evidence-based drug approvals for all FDA-approved products.” “You have my commitment to follow the independent scientific review process at the FDA,” Makary said. — Nicole DeFeudis . . . . . Makary won’t commit to rescheduling flu vaccine meeting (10:30am ET): Makary got into a heated exchange with Sen. Patty Murray (D-WA) where she continually questioned him on whether he would reschedule an advisory committee meeting on the upcoming flu vaccine, which the FDA typically does on a yearly basis. Makary declined to promise that he would “immediately reconvene” that meeting. But he did say he would “immediately reevaluate” it. Makary also questioned why VRBPAC has “rubber-stamped” whatever the WHO’s Global Influenza Programme says the US should include, which is typically based on what flu strains are circulating in the Southern Hemisphere. Cassidy questioned the “rubber stamp” comment and Makary conceded, “Some years, we don’t get it very well, but it’s the best we can do with the data we have available at the time.” Makary later added: “I have no preconceived plans to rearrange that committee or any committee.” — Zachary Brennan . . . . . Cassidy pushes Makary (10:20am ET): These hearings on Trump’s health nominees have turned into a showcase for committee Chairman Sen. Bill Cassidy (R-LA). Not only has he been a pivotal vote in the narrowly divided Senate, he’s one of the few doctors in the Senate and is almost alone in having a strong grip on the subject matter. You can tell these aren’t just staff-written questions, and he’s been engaging (and debating) nominees on the substance, especially on vaccine-related issues. He’s been a reliable vote for Trump’s picks (Kennedy was the only one where Cassidy’s “yes” seemed in doubt). But he’s pushing these nominees and getting them on the record about some of the crucial issues they’ll be dealing with. — Drew Armstrong . . . . . Makary, Bhattacharya committee votes slated for next Thursday (9:30am ET): The Senate HELP Committee is scheduled to vote on both Makary and Bhattacharya’s nominations in the same session. The nominees are likely to advance to the full Senate, given the breezy hearing yesterday and the fact that so far every one of Trump’s cabinet picks has been confirmed. After the votes, the committee is slated to immediately proceed to a hearing for Trump’s CDC director pick, David Weldon. — Alexis Kramer . . . . . Round two for Senate HELP this week (8:45am ET): It’s now Makary’s turn to face the Senate HELP committee after a relatively smooth-sailing hearing on Wednesday for Trump’s NIH pick. Senators pressed Jay Bhattacharya on several hot-button issues like vaccine safety and staff and funding cuts, but the NIH director nominee appeared to give them satisfactory answers. Committee chair Sen. Bill Cassidy (R-LA) asked Bhattacharya about his stance on a debunked link between vaccines and autism, an issue that initially left Cassidy struggling with Kennedy’s nomination for HHS secretary (though the senator ultimately voted for him). Makary is likely to hear a similar line of questioning on vaccines and autism today. Other topics that he might be asked on: