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Oct 14, 2025  |  
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John Gerardi


NextImg:FDA’s Approval of Mifepristone Generic Raises Troubling Questions

For one: Why did the administration not put up a bigger fight on this issue?

P ro-lifers were disturbed when news broke of the FDA’s approval of a generic form of the “abortion pill,” mifepristone, to be produced by the aggressively pro-abortion Evita Solutions pharmaceutical company. Last week, 51 Republican senators signed on to a letter calling on the HHS and FDA to immediately act to reevaluate its decision and restrict mifepristone.

Why, pro-lifers asked, is the FDA of a purportedly pro-life administration approving a new form of the abortion pill, when it has not even completed a promised review of its health and safety guidelines? The answer, I fear, is simple: the Trump administration simply does not care about restricting mifepristone and will not act aggressively to restrict it until the political calculus changes.

It’s helpful to review why this issue is so important. From 2021 — when Biden’s FDA approved telemedicine visits rather than in-person appointments to prescribe the abortion pill and allowed the drug to be shipped to patients or pharmacies directly — to today, the total number of abortions has jumped by 100,000 per year, with mifepristone now accounting for over 60 percent of more than 1 million annual American abortions. Mifepristone is, quite simply, the single biggest driver of abortion in America today, and how it is regulated has a tangible, real-world impact in ending hundreds of thousands of lives each year. Putting another generic version of mifepristone on the market makes it more accessible and less costly, leading to more abortions.

I say “another,” because this is not the first time a Trump FDA has approved a generic version of mifepristone. The FDA approved a mifepristone generic from GenBioPro in 2019. This was before the massive spike in abortion numbers precipitated by Biden’s loosening of mifepristone restrictions in 2021 and the subsequent focus on the abortion pill’s significance by pro-life groups. Still, conservative groups such as the Heritage Foundation noted the approval at the time.

HHS Secretary Robert F. Kennedy Jr. engaged in some damage control to defend the FDA’s action. He argued that the FDA’s hands are tied when it comes to approvals for generic versions of drugs the FDA has already approved, with drug companies being entitled to approvals as long as they meet certain basic requirements. He committed to the FDA’s ongoing review of the abortion pill and made some hopeful statements regarding his concerns for mifepristone’s dangers.

I am glad Kennedy sounds committed to the review of mifepristone, but the administration’s overall posture raises troubling questions with inescapably unpleasant answers. To wit:

  1. It is hard to believe that the FDA couldn’t have delayed this approval or otherwise given more resistance to Evita’s efforts to produce this generic drug. The Trump administration has fought for various other priorities with creative lawyering (for example, using the rarely employed 18th century Alien Enemies Act to deport unlawful immigrants), and is not afraid to pick a fight in the courts over causes it believes in. Why did they not put up a bigger fight on this issue? Peter Laffin from the Washington Examiner has argued that the relevant law is not as rigid as Kennedy makes it out to be and that the ongoing safety review could have been cited as a rationale for stopping the approval. The 51 Republican senators who called on the FDA and HHS to change course agree.
  2. Why is the administration bothering with a health and safety review of mifepristone in the first place? Conservatives have been arguing for years that the FDA’s original approval of mifepristone in 2000 and the subsequent loosening of its health and safety restrictions in 2016 and 2021 were not just incorrect or immoral, but actually unlawful. The original FDA approval of mifepristone in 2000 utilized an expedited approval process for medications that treat “serious or life-threatening illness” (which pregnancy is not), and the 2016 and 2021 deregulations did not consider safety data utilizing the lesser standards the FDA ultimately adopted. This was the basis for the FDA v. Alliance for Hippocratic Medicine litigation, which lost at the Supreme Court in 2024 only on standing grounds. Before the case got to the Supreme Court, though, the Northern District of Texas ruled that the 2000 approval was unlawful, and the Fifth Circuit ruled that the 2016 and 2021 deregulations were unlawful. Why not rescind those regulatory decisions on the basis of unlawfulness, without bothering to wait on a safety review?
  3. Why did it take eight months to begin mifepristone’s health and safety review, which was promised during Secretary Kennedy and FDA Commissioner Marty Makary’s confirmation hearings at the start of the administration?
  4. Has the approval of a new generic version of mifepristone undermined the promised health and safety review already? Senator Josh Hawley — who has consistently been a bulldog in fighting against mifepristone and calling Trump officials to account over it — expressed deep concern in a letter to Commissioner Makary that new health restrictions arising out of the FDA’s promised review might not apply to the newly approved generic drug.
  5. Why is the administration not working to restrict mifepristone in other ways? Why did Trump explicitly disavow enforcement of the Comstock Act, the Ulysses Grant-era law (75 years younger than the Alien Enemies Act) that bans interstate shipment of abortifacients? Why isn’t there any movement to restrict illegal shipments of mifepristone from foreign countries? Interstate and international shipments of mifepristone undermine the ability of pro-life states to regulate abortion on their own, a principle for which Trump has repeatedly affirmed his support. The Economist has reported that abortion numbers have stayed steady in abortion-restricting states post-Dobbs specifically because of illegal shipments of mifepristone from “Abortion Shield Law”–enacting blue states and foreign countries.
  6. Most important: What exactly is the Trump administration’s position on mifepristone, in general? Nobody from the administration seems willing to elaborate. Neither Trump nor his surrogates will flatly say that mifepristone is bad, that it was wrongly approved, that it undermines states, or that it is more dangerous than surgical abortions. Administration officials instead maintain tight lips, waiting on the results of a health and safety review (of unknown duration or outcome). It is one of few issues where Trump and Kennedy are loath to give bold and clear commitments. Why are they playing it so close to the vest?

Those are the questions, and lots of Trump-supporting pro-lifers don’t want to hear the answers. Sadly, it appears that President Trump either does not care about restricting mifepristone, or he actively wants to keep it on the market.

There is disturbing evidence of the latter. In his debate with President Biden in June 2024, shortly after the Supreme Court issued its ruling in FDA v. Alliance for Hippocratic Medicine, then-candidate Trump said, “First of all, the Supreme Court just approved the abortion pill. And I agree with their decision to have done that, and I will not block it.” Now, the Court did not actually rule on the merits of whether the abortion pill was legally approved and deregulated, but Trump acted like it had and agreed with the notion that it was rightly on the market. JD Vance agreed in July of 2024 that he supported mifepristone “being accessible.” This past May, the Trump DOJ even went so far as to defend the FDA’s mifepristone rules against a lawsuit from various pro-life states, though this was chiefly to vindicate the notion that states lack standing to sue the administration over various policy actions.

How seriously should pro-lifers take these pro-mifepristone affirmations? Trump clearly viewed abortion as an issue that was toxic for him in 2024. Pro-life Trump apologists might argue that he said what was necessary to win, but now he will govern in a more pro-life fashion. There is some merit to this argument: Trump has governed in a more pro-life fashion than he campaigned, most significantly in cutting federal funding from abortion providers like Planned Parenthood. The promised health and safety review wouldn’t be happening if Trump were totally closed off to regulating mifepristone more. And his campaign comments leave some wiggle room: Preserving “access” to mifepristone does not foreclose the possibility of reinstating the pre-2016 regulations on mifepristone, which would limit, but not eliminate, its accessibility.

The most logical explanation for Trump’s relative inaction on mifepristone is that he doesn’t care very much about the issue and thinks there is more risk than reward in regulating mifepristone aggressively. Trump’s conduct makes sense in light of the “transactionally pro-life” attitude he has adopted since 2016. By this logic, Trump will only act on mifepristone insofar as it is necessary to placate social conservatives without hurting his overall approval too badly. Thus, he does the minimum: He keeps pro-lifers happy with a promised safety review, but he delays things (perhaps waiting until after the 2026 midterms), commits to very little, and doesn’t make aggressive, quick moves that he thinks will be broadly unpopular. However, if the Republican senators’ letter is any indication, Trump may have underappreciated how much action on mifepristone was necessary to keep his base happy.

In a Wall Street Journal op-ed, former Vice President Mike Pence blasted the approval of the new mifepristone generic and called on President Trump to remove Secretary Kennedy if he refuses to institute restrictions on mifepristone. I think Pence misses the point (and also glosses over the 2019 approval of a generic mifepristone, when he was Trump’s vice president). Kennedy is not the problem here — if anything, Kennedy’s comments on the question have been better than Trump’s or Makary’s. It’s the president who does not want to move aggressively, and his subordinates are simply following his lead.

This unfortunate inaction on mifepristone does not eliminate the significance of the pro-life accomplishments of the two Trump terms, which have been epoch-changing. Nonetheless, if Trump fails to engage with the mifepristone issue within the short window of this presidency, it will be a disastrous loss of a precious opportunity that costs thousands of lives.

I commend the various pro-life advocacy groups and their allies in Congress who are keeping the pressure on the Trump administration to take action, and swiftly. Trump may not act without it, and lives hang in the balance.