The Trump administration is taking long-overdue action to protect women from the dangerous abortion pill mifepristone, after decades of reckless approvals and loosened safeguards under Clinton, Obama and Biden.
Since its approval in 2000, mifepristone has been used by an estimated 7.5 million American women to end an unborn child. The drug is a two-part process typically taken up to 10 weeks in the pregnancy.
The FDA has received reports of serious side effects from the drug. By law, the FDA can require special safety rules, called a ‘REMS’ program, if a drug poses serious risks. Recent studies, including one mentioned by the attorneys general, suggest that women could be at risk if the drug is provided without enough medical supervision.
The Health and Human Services Secretary Robert F. Kennedy Jr. notes that in one 12 year period, 2,740 ‘adverse events’ were observed with the abortion pill.
In a letter sent to state attorneys general, HHS Secretary Kennedy and FDA Commissioner Martin Makary announced that the FDA is launching a full review of the abortion drug’s safety. For the first time in years, federal officials are acknowledging what has been swept under the rug: thousands of women have suffered serious complications from mifepristone since its approval in 2000, including hundreds of cases of severe blood loss requiring emergency transfusions.
You can read the letter from Secretary Kennedy to state Attorney Generals exclusively at the Gateway Pundit, here:
Secretary Kennedy had previously said this past May that he was going to scrutinize the abortion pill. Left-wing groups like the American Civil Liberties Union erupted at the potential that HHS would review and critically assess the health risks to women posed by the drug’s side effects and complications.
The FDA originally approved the drug in 2000 for use only through the first 7 weeks of pregnancy. But under the Obama and Biden administrations, restrictions were repeatedly loosened: first extending use to 10 weeks, then removing in-person doctor requirements, and even eliminating the obligation for prescribers to report most serious side effects. These changes put women at risk while shielding the true dangers of chemical abortion from the public.
Prior Democrat administrations have increasingly made the abortion pill more easily-obtainable and reduced the regulations around it.
- The FDA approved mifepristone in 2000 for use up to 7 weeks of pregnancy.
- In 2016, that limit was extended to 10 weeks and some rules were relaxed.
- In 2023, the FDA removed the rule requiring patients to get the drug in person.
Citing independent studies, including a recent report by the Ethics and Public Policy Center, RFK Jr. and Dr. Makary said it is clear that “adequate consideration” was missing from prior approvals and that the safety of women must come first. The new review will examine real-world outcomes and determine whether stronger safeguards, or even tighter restrictions, are needed.
Now, under Kennedy’s leadership, HHS and the FDA will conduct a new, thorough safety review of mifepristone to ensure it is safe for women.
This marks a sharp break from the Biden years, when federal regulators worked hand-in-glove with the nation’s $2 billion a year plus abortion industry to make mifepristone easier to distribute while downplaying the risks. Now, under President Trump, the FDA is finally putting women’s health ahead of Planned Parenthood’s profits.
Kennedy has repeatedly said that he generally supports abortion rights in early pregnancy. Left-wing groups have said in response that, instead, he is an anti-abortion extremist.
Kennedy’s letter does not mention criminalizing abortion, merely reviewing the normal side effects and complications that the controversial abortion drug has on its users.
The abortion pill is manufactured by Danco Laboratories in New York, GenBioPro of California, and Corcept Therapeutics in California.