Awaiting Trump's abortion pill posture

Politico

28-01-2025

Presented by Boehringer Ingelheim
With Alice Miranda Ollstein
Driving The Day
WHAT'S IN STORE FOR MIFEPRISTONE — President Donald Trump issued executive orders late Friday reviving some of his first term's anti-abortion policies, like restrictions on federal funding for family planning and some overseas health programs. But he has yet to take action on a major target for the groups who embrace those moves — the FDA's Biden-era decisions loosening restrictions around access to abortion pills.
They specifically want a ban on telehealth prescription and mail delivery of mifepristone, the first drug used in the medication abortion regimen in the U.S., Alice reports. Ideally, in their view, Trump's FDA would ban the drug altogether — though such a move would be sure to spark legal action from the pharma industry.
'I want to hear him say things like, 'I'm holding everybody equally accountable to the law. If you don't do an environmental assessment, guess what? Your drug is being pulled from the market,'' Kristan Hawkins, the president of Students for Life of America, told Alice.
'It'd also be great to hear him say, 'The REMS are very important, and they shouldn't be removed simply because a presidency wants to put access to abortion over safety,'' she added, referring to the FDA's risk evaluation and mitigation strategies program, which puts conditions on the use of certain drugs. 'It's absolutely asinine why they would remove the REMS on requiring an ultrasound before giving these chemical abortion drugs out.'
What's on the chopping block: Under President Joe Biden, the FDA permitted telehealth providers to prescribe and mail mifepristone, eliminating a previous requirement stipulating the drug had to be dispensed in person.
The agency also allowed brick-and-mortar pharmacies to become certified to dispense the medication; previously, the drug was typically stocked by abortion providers, given the myriad limitations around its prescription.
Murky outlook: Before his swearing-in, Trump suggested he wouldn't do anything to further limit the availability of abortion pills, roiling the anti-abortion movement and muddying predictions about what's coming from the FDA on the lightning-rod issue.
Still, that's not a guarantee. And while most of those organizations haven't opposed his selection of Robert F. Kennedy Jr. — a former Democrat who's previously supported abortion rights — to lead HHS, they're waiting to learn his position during his confirmation hearings this week before endorsing him, Alice and POLITICO's Daniel Payne report.
Makary's mark: Since mifepristone access is largely in the FDA's wheelhouse, Trump's next commissioner will play a significant role in any changes to the pill's availability.
FDA nominee Dr. Marty Makary suggested his discomfort with abortion on Fox News in 2022, claiming that fetuses can feel pain starting around 15 weeks of gestation. Abortion rights groups labeled his statements as disinformation.
Some anti-abortion groups like Catholic Vote called Makary a 'pro-life' pick after his nomination was announced. But other than that interview, he doesn't appear to have much of a public record on the issue — something that will surely change during the Senate confirmation process.
IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We're gearing up for a big week on the Hill. What under-the-radar pharma issues are you hoping come up during Kennedy's Senate confirmation hearings?
Send your tips to David Lim ([e-mail] or @davidalim) and Lauren Gardner ([e-mail] or @Gardner_LM).
Eye on the FDA
BUSINESS CARRIES ON (IT SEEMS) — Wall Street has an answer on whether PDUFA dates will be honored: The FDA is still issuing product decisions during the Trump administration's communications pause.
On Sunday, the FDA approved Biogen and Eisai's application for monthly intravenous maintenance dosing for their Alzheimer's drug Leqembi. It had been scheduled for an agency decision under the prescription drug user fee agreement by Saturday.
'For upcoming PDUFAs, the question was not whether the outcome would change, but whether they would be delayed,' said Chris Meekins, a health care analyst at investment firm Raymond James. 'The approval over the weekend shows angst around the transition's impact on FDA was overwrought.'
Steven Grossman, author of the blog FDA Matters and former executive director of the Alliance for a Stronger FDA, said it makes sense that product work appears to continue at the agency despite the hold on policy decisions and external communications given user fee deadlines.
'Whether formal or informal, public or not public, there is always a slow-down or freeze until the new teams can review and decide on pending items,' Grossman said. 'Often, transition teams have this under control by Inauguration Day, but not always and not everything.'
What's next: The big question, he added, is whether the freeze on other activities extends beyond Feb. 1.
Vertex Pharmaceuticals is slated to receive a decision on its pain reliever suzetrigine on Thursday.
On the Hill
RFK OPEN TO MARCHING IN? Robert F. Kennedy Jr. signaled to staffers on Capitol Hill he is open to a key progressive proposal to lower drug prices: seizing patents of high-priced drugs, POLITICO's Sophia Cai and Adam Cancryn report.
President Donald Trump's health secretary nominee indicated favorability with the proposal last week during a closed-door meeting with staffers on the Senate Finance Committee, according to three people familiar with the exchange granted anonymity to speak freely.
Kennedy is expected to go before the committee Wednesday for his confirmation hearing.
Democrats and former President Joe Biden have long supported seizing patents for high-cost drugs and licensing them to other manufacturers who could make and sell them for less.
Kennedy's spokesperson, Katie Miller, disputed the characterization of the conversation.
'This is once again another example of POLITICO carrying Democrats' water. After POLITICO was told this did not occur the way Democrats have described it, they're still seeking to publish it in an attempt to denigrate Bobby Kennedy and create a story where there is not one,' she said. 'The fact remains, this did not occur. This is a smear campaign against Donald J. Trump.'
Republicans have long blasted the policy, saying it would kill American innovation.
In the Courts
NOVO: HURRY UP ALREADY — Novo Nordisk filed a motion Monday with the federal Third Circuit appellate court, urging it to expedite oral arguments in its Medicare drug price negotiation challenge.
The filing came days after the outgoing Biden administration announced the 15 drugs subject to the second round of negotiations at CMS. That list includes three of Novo's blockbuster GLP-1 brands to treat diabetes and/or obesity: Rybelsus, Ozempic and Wegovy.
The company objects to CMS aggregating those drugs as one 'product' — as the agency did with several of its insulins in the first round — because they share an active ingredient, semaglutide.
'Novo Nordisk's now-impending second round of price 'negotiations' is good cause that justifies expediting the remainder of this appeal to clarify Novo Nordisk's rights and CMS's authority under the IRA, the Administrative Procedure Act, and the Constitution,' the company's lawyers wrote.
In Congress
PAUL ISSUES COVID SUBPOENAS — Senate Homeland Security Chair Rand Paul (R-Ky.) said Monday he subpoenaed 14 federal agencies earlier this month regarding the origins of Covid-19 and 'taxpayer-funded gain-of-function research.'
The subpoenas were issued on Jan. 13 — during the Biden administration's final week — 'without objection from the minority,' according to the panel.
Agencies that received the orders include the NIH, HHS and the U.S. Agency for International Development.
'The goal of the investigation will be to critique the process that allowed this dangerous research, that may have led to the pandemic, to occur in a foreign country under unsafe protocols and to ensure that there is sufficient oversight and review going forward, making sure a mistake of this magnitude never happens again,' Paul said in a statement.
ICYMI: The CIA said Saturday that the Covid virus was more likely to have originated from a lab than an animal, POLITICO's Carmen Paun and John Sakellariadis write.
Document Drawer
American Enterprise Institute's Brian Miller, Health Policy Insights consultant Deborah Williams and Evernorth Health Services' Steven Zima examine alternative drug-pricing approaches to the Medicaid rebate program and Medicare Part B's average sale price plus 6 percent.
WHAT WE'RE READING
Top Chinese doctors are raising alarm around a government program favoring domestically made drugs, suggesting manufacturers are sacrificing quality to sell their products at bargain prices, The New York Times' Alexandra Stevenson and Zixu Wang report.
The NIH's acting director clarified the staff activities that can continue during the Trump administration's freeze on communications, STAT's Sarah Owermohle reports.
The U.S. reported the first cases of H5N9 bird flu in poultry at a duck farm in California, Reuters' Sybille de La Hamaide reports.