Mifepristone

President Donald Trump’s new administration defended Biden-era restrictions on the abortion pill mifepristone, marking one of the first times it’s voiced its stance in the ongoing lawsuits over the drug. The DOJ’s court filing in the Western District of Virginia is part of a federal case brought by abortion supporters, who argue that FDA restrictions on mifepristone are burdensome and unnecessary. Government lawyers argued on Tuesday that remaining requirements on the drug should stay in place. The plaintiffs, led by the Whole Woman’s Health Alliance, have argued that the FDA violated the Administrative Procedure Act by maintaining some elements of a risk evaluation and mitigation strategy on the drug and adding new requirements to that REMS in 2023 . The plaintiffs contend the government has not provided an adequate rationale for imposing certain barriers, namely a requirement that the drug may only be dispensed by certified prescribers and pharmacies. At the core of the case is whether the FDA should’ve made it easier to dispense and obtain mifepristone when it adjusted its REMS. The Trump administration, which has indicated that the requirements are too lenient as is, is defending the FDA’s existing position. The DOJ said Tuesday that the plaintiffs’ claims were “meritless” and said the FDA’s decision is based on sound data. The case is separate from one in the Northern District of Texas that will be more illuminating. There, the FDA is being sued over its loosening of other mifepristone restrictions, with three states arguing that it has allowed abortion providers to use telemedicine to mail abortion pills even when that breaks state law. Republican senators have lobbed questions about the administration’s stance on mifepristone to Trump’s health nominees in their confirmation hearings, prodding whether they’d commit to changing the government’s tune. That came to a head when a lawyer who had just been hired to be chief counsel at the FDA departed within days. Hilary Perkins was hired at the DOJ in Trump’s first term and defended the government’s stance on mifepristone when both Trump and Biden were in office. Sen. Josh Hawley (R-MO) reportedly threatened to vote against Trump’s pick to lead the FDA, Marty Makary, if she was not removed from the post, according to the New York Times . The FDA announced March 13 that Perkins resigned. In an interview with the Times, Perkins said she’s a pro-life conservative who was just doing her job as a career attorney. “He should be fighting for me, not against me,” she said.

Welcome back to Endpoints Weekly! This week was another busy one in DC, with two Senate hearings for Trump’s picks to lead the NIH and FDA, more actions from the Department of Government Efficiency, talk of tariffs, and more. We’ll walk you through it. Plus, another big pharma is joining the obesity race — but not with a GLP-1. And a small Swiss biotech quietly disclosed that it would halt a trial for an oral Alzheimer’s drug after two of its top competitors Eli Lilly and Biogen also scrapped their own oral Alzheimer’s drugs. Endpoints’ Kyle LaHucik has the latest on those stories below. Stay tuned next week as we cover the Senate HELP Committee’s scheduled votes on FDA nominee Marty Makary and NIH pick Jay Bhattacharya. On the same day, the committee is set to hold a confirmation hearing for CDC nominee David Weldon. See you on Monday! — Nicole DeFeudis President Donald Trump’s picks to lead the NIH and FDA emerged from Senate confirmation hearings relatively unscathed this week. Here’s a run-down of where the nominees stand on key topics: 💉 Vaccines: FDA nominee Marty Makary said “vaccines save lives” during his hearing on Thursday. The statement is a departure from comments made by HHS Secretary Robert F. Kennedy Jr., who declined to refute his past claims about a link between vaccines and autism in a January Senate hearing. NIH pick Jay Bhattacharya said he “fully supports” measles vaccinations and does not believe there’s a link between autism and vaccines. However, he called for more study to combat falling vaccination rates in some parts of the country. “I’m convinced we have good data on MMR and autism, but if other people don’t agree with me and don’t vaccinate their children, the one lever I have is to give them good data,” he said. 💼 Staff cuts: Both nominees said they were not involved in recent staff cuts at the NIH and FDA. When pressed by Sen. Tim Kaine (D-VA) about his thoughts on “willy, nilly, random” layoffs at the FDA, Makary cited his surgical experience. “Look, I’m a surgeon, so you know, I’m going to give you a surgical answer,” he said. Bhattacharya said he would “look very carefully at the personnel decisions.” When repeatedly asked, he said, “the personnel decisions are hard to talk about unless I’m actually confirmed and I have more data.” 💵 NIH grants: Sens. Susan Collins (R-ME) and Patty Murray (D-WA) both raised concerns about the NIH’s planned 15% cap on indirect cost reimbursements for grant recipients. Bhattacharya didn’t contradict the Trump administration’s cuts or say he would reverse course. “I want to make sure that the money goes to the research,” he said. He told Collins he would “make sure that your concerns are addressed.” 💊 Medication abortion: Makary was asked numerous times about his stance on access to the abortion pill mifepristone . Some Republican senators asked if he would reinstate an in-person dispensing requirement for mifepristone, which was removed by the Biden administration in 2021. Makary said he has “no preconceived plans” on mifepristone, and will “take a solid, hard look at the data.” The Senate HELP committee is expected to vote on Bhattacharya and Makary’s nominations next Thursday. 🏭 President Donald Trump’s tariffs are causing the biopharma industry to rethink where it produces and manufactures its drug products, with several notable companies commenting on the topic this week. Pfizer CEO Albert Bourla, who has visibly tried to put himself in Trump’s good graces since the election, said his company could “quickly” onshore drug production if it needed to mitigate the effects of the tariffs. Pfizer is in a better position thanks to its US manufacturing network, Bourla said, potentially giving it an advantage over some rivals. But he cautioned the situation remains “volatile,” and he said last month that any tariffs in Europe would likely impact Pfizer in some form. Trump has yet to specifically impose tariffs against pharma goods produced in Europe, but has threatened a 25% tax import on all pharma goods into the US. Eli Lilly, meanwhile, is asking state governments to send pitches about why the company should invest in them as part of the company’s $27 billion US manufacturing promise . It’s an unusual move, but one that comes due to the “unprecedented nature” of the investment, according to a company spokesperson. Lilly is already in negotiations with an undisclosed number of states. At least one expert believes the company will likely select areas with universities and academic institutions to tap into their local talent pools. Merck KGaA also expects to be able to weather the tariffs thanks to its earlier efforts to move manufacturing sites to the US. CEO Belén Garijo believes the situation will be “manageable,” and in October the company announced plans to boost antibody-drug conjugate manufacturing in St. Louis. But one company that could see stronger headwinds is Bavarian Nordic , which has contracts with the US government to stockpile its drug in the event of smallpox and mpox outbreaks. CEO Paul Chaplin said the onshoring process would be doable, but he warned it could take five to 10 years to complete . One of the last Big Pharma holdouts in obesity is now in the game, as AbbVie partnered with the Danish biotech Gubra on an experimental medicine called GUBamy, also known as GUB014295. The program is not a GLP-1, but rather a long-acting amylin analog, which is a peptide-based drug that could be more complex to manufacture. It’s currently in the multiple ascending dose portion of Phase 1 testing, with interim results expected before July. There are multiple other companies in the amylin space, including Zealand, Metsera, Structure and AstraZeneca, among others. But recent attempts at amylin have not always succeeded. Novo Nordisk tested its GLP-1 drug Wegovy in combination with an amylin program and disappointed investors , while Zealand is still searching for a partner for its own amylin drug. 🥼Two days after announcing plans to shut down an FDA lab devoted to ensuring the US drug supply remains safe and potent, the Trump administration changed its plans . The St. Louis lab, known as the Office of Testing and Research, tests the quality of drugs and investigates high-profile drug safety issues. The lab was one of about 30 FDA facilities whose leases were marked for termination by DOGE. “They are the FDA’s premier drug analysis lab,” former FDA Acting Commissioner Janet Woodcock told Endpoints. “Congress has been constantly on FDA to make sure imported drugs are of adequate quality, and the St. Louis lab is the foundation of that.” A small Swiss biotech called Asceneuron quietly disclosed it would halt a trial for an oral Alzheimer’s drug this week, posting an update to the government’s clinical trials registry saying it was due to a “strategic decision.” The company’s CEO, Barbara Angehrn Pavik, declined to provide a reason for the trial termination. Asceneuron’s decision comes after two top competitors, Eli Lilly and Biogen, both scrapped their own oral Alzheimer’s drugs. DON’T MISS: