The Tamesis
The Food and Drug Administration has initiated safety research Abortion Pill MifepristoneA senior FDA official confirmed to CBS News that the move could pave the way for the Trump administration to restrict access to the drug.
The official said it would be a retrospective study of hundreds of thousands of cases. Interim results from the study could be released in July, but the official noted that the timing of final results will depend on the design of secondary analyzes after the interim results come out.
The Wall Street Journal first reported 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 that “HHS – through the FDA – is conducting its own review of the evidence, including real-world results and evidence related to the drug’s safety and effectiveness.”
Drug under renewed scrutiny after Biden administration issues memo Lift restrictions This requires in-person distribution of the medication, as well as providing mifepristone via telemedicine and by mail.
Last year, Louisiana filed a lawsuit challenging the FDA’s decision to allow mifepristone to be mailed.
On May 4, the U.S. Court of Appeals for the Fifth Circuit temporarily reinstated the rule that mifepristone can only be dispensed in person.
However, the following week, the Supreme Court Set aside lower court order Currently, mifepristone is allowed to continue being shipped to patients by mail while the Louisiana case plays out in court.
Mifepristone was first approved by the FDA in 2000 as a safe way to terminate early pregnancy and is often taken with a second drug, misoprostol.
Last year, when asked whether a review of mifepristone would lead to a ban, CBS News medical contributor Dr. Celine Gounder said it would be difficult for the FDA to withdraw its approval, an unusual move that would soon lead to a legal challenge.
However, Gounder said depending on the outcome of the safety review, it could make access more difficult, limit the delivery of medications via telemedicine or mail, or limit the ability to prescribe medications to doctors rather than the physician assistants or nurse practitioners who are also currently able to prescribe them.
