Get you up to speed: FDA launches safety study for abortion pill mifepristone, source says
The Food and Drug Administration has initiated a safety study of the abortion pill mifepristone, as confirmed by a senior FDA official. The retrospective study will examine hundreds of thousands of cases, with interim results expected in July.
The Food and Drug Administration’s safety study of mifepristone will involve a retrospective analysis of hundreds of thousands of cases, with interim results expected in July. Meanwhile, the U.S. Supreme Court has temporarily allowed the delivery of mifepristone through the mail while legal challenges continue regarding its distribution.
The Food and Drug Administration has initiated a safety study of mifepristone, with interim results expected by July, which may inform future restrictions on the medication. This follows renewed scrutiny after the Biden administration eased access protocols, amid ongoing legal challenges, including a lawsuit from Louisiana that contested mifepristone’s mail delivery.
What remains unclear — The timeline for the final results of the FDA’s safety study on mifepristone has not been specified.
FDA initiates safety study of abortion pill mifepristone, official confirms
The Food and Drug Administration has launched a safety study of the abortion pill mifepristone, a senior FDA official confirmed to WTX US News, a step that could create a path for the Trump administration to restrict access to the medication.
It will be a retrospective study of hundreds of thousands of cases, according to the official. The interim results of the study could be released in July, but the official noted the timing of the final results will depend on the design of a secondary analysis after the interim results come in.
The Wall Street Journal was first to report on the launch of the study.
Last September, Health and Human Services Secretary Robert F. Kennedy Jr. wrote in a letter to several Republican state attorneys general that the FDA was reviewing the safety of mifepristone.
At the time, Kennedy and then-FDA Commissioner Martin Makary wrote, “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
Yet Makary came under scrutiny from some Congressional Republicans and anti-abortion groups who believed the agency was dragging its feet on the study under his watch for political reasons.
The drug came under renewed scrutiny after the Biden administration issued a memorandum lifting restrictions that required the drug to be dispensed in-person and giving access to mifepristone via telehealth and by mail.
Last year, the state of Louisiana filed a lawsuit challenging the FDA’s decision to allow mifepristone to be delivered by mail.
On May 4, the U.S. Court of Appeals for the 5th Circuit temporarily reinstated the rule requiring mifepristone to only be dispensed in person.
However, the following week, the Supreme Court set aside the lower court order and allowing, for now, mifepristone to continue to be delivered to patients through the mail while the Louisiana case plays out in the courts.
Mifepristone, which was first approved by the FDA in 2000 as a safe way to end early pregnancies, is typically taken with a second drug, misoprostol.
Asked last year whether a review of mifepristone could lead to a ban, WTX US News medical contributor Dr. Celine Gounder suggested it would be difficult for the FDA to withdraw approval, an extraordinary step that would quickly draw legal challenges.
However, Gounder said that depending on what the safety review finds, it could make access more difficult, limiting the drug’s availability through telehealth or by mail, or restricting the ability to prescribe it to doctors, rather than physician assistants or nurses who are also currently able to prescribe it.