posted May 14, 2025 06:46 PM
WASHINGTON — At a Senate hearing today, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., announced that he has directed the Food and Drug Administration (FDA) to undertake a review of its regulations on mifepristone, a safe and effective medication used in most U.S. abortions and as part of a gold-standard treatment regimen for miscarriage. There is no scientific basis for this review, which Kennedy indicated will center on a fatally-flawed paper on mifepristone’s safety recently released by the Ethics and Public Policy Center, a Project 2025 sponsor organization. Kennedy also stated that the FDA’s “policy changes will ultimately go through the White House, through President Trump.”“Secretary Kennedy just revealed that he has ordered the FDA to consider making it harder for people to get medication abortions based on propaganda pushed out by a Project 2025 sponsor,” said Julia Kaye, senior staff attorney for the Reproductive Freedom Project at the American Civil Liberties Union. “Even leading anti-abortion advocates admit this junk science is ‘not a study in the traditional sense,’ and is ‘not conclusive proof of anything,’ but that clearly won’t stop extremist politicians from waving it around as a basis to restrict abortion.
“Even more alarming is Secretary Kennedy’s admission that the FDA’s decision on medication abortion will come not from scientists or doctors but ‘from the White House.’ We should all be scared if our access to safe, FDA-approved medications turns on President Trump’s gut instinct rather than credible scientific evidence. This new FDA review has nothing to do with science and everything to do with teeing up nationwide restrictions on abortion. If the FDA moves forward with this politically motivated review, that is a dangerous sign that the president is going back on his promises to voters not to restrict abortion access even further.”
Mifepristone is described by leading medical authorities as among the safest medications being used today, based on hundreds of peer-reviewed studies and real-world data from 7.5 million patient uses over 25 years.
Nevertheless, Secretary Kennedy’s statements today indicate that the new review will focus on a report on medication abortion recently released by a Project 2025 sponsor organization whose mission is to insert religious ideology into law and policy. One of the paper’s two co-authors recently published a book called “Abortion Harms Everything and Solves Nothing.” The paper has numerous flaws making it unfit for use in a scientific review, including:
Hiding major aspects of the methodology, including the database from which patient data was sourced and the criteria the authors used to identify more than half of the alleged adverse events cited in the report;
Classifying routine follow-up visits and emergency room visits without any treatment as “serious adverse events,” contradicting longstanding FDA definitions; and
Skewing the findings by including data on patients using mifepristone for miscarriage and other non-abortion indications.
The pseudo-science paper echoes calls made in Project 2025 to severely restrict access to medication abortion nationwide. Commissioner Makary previously indicated that the FDA may move to ban patients nationwide from obtaining medication abortion by mail or at pharmacies after meeting with their prescriber via telemedicine, a method used in 20 percent of U.S. abortions today.
The FDA’s former requirement that medication abortion patients pick up their mifepristone prescription in person at a hospital, clinic, or medical office was first blocked during the COVID-19 pandemic as the result of litigation brought in May 2020 by the ACLU (ACOG v. FDA) on behalf of leading health care providers. The FDA formally lifted the in-person dispensing requirement in January 2023, citing extensive scientific evidence confirming that mifepristone remained just as safe during the period when this burdensome requirement was not enforced.
Lindaland
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posted May 14, 2025 06:45 PM