FDA Commissioner Vows Mifepristone Review
FDA Commissioner Dr. Marty Makary
U.S. Food and Drug Administration Commissioner Marty Makary has committed to review the safety of the chemical abortion drug mifepristone.
In a letter dated June 2 to Senator Josh Hawley of Missouri, Commissioner Makary stated:
“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy. As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.”
Commissioner Makary’s letter was in response to a letter to him from Senator Hawley dated April 28 urging him to review new data released that same day by the Ethics and Public Policy Center (EPPC) on the dangers of mifepristone and the need to “immediately reinstate” critical FDA safeguards on the drug’s use.
As reported by Council for Life, the key findings of the EPPC study revealed over one in ten women experience a Serious Adverse Event following a mifepristone abortion, a rate 22 times higher than the rate currently listed on the FDA drug label. (See Council for Life News HERE)
At his confirmation hearing in March, Commissioner Makary expressed concern about the current policy issued during President Biden’s Administration that allows women to obtain the pills without an in person doctor’s appointment and represented that he would “take a solid, hard look at the data.”
(See National Review HERE and New York Times HERE)
Senator Josh Hawley shared his June 2 Letter
from FDA Commissioner Marty Makary on X
Trump Administration Rescinds Biden Administration ER Abortion Mandate Under EMTALA
Abortion rights supporters outside the U.S. Supreme Court as it hears arguments
in the EMTALA case on April 24, 2024. Photograph: Saul Loeb/AFP via Getty Images
On June 3, the Trump Administration rescinded a mandate issued by the Biden Administration that preempted state abortion bans by requiring doctors to perform abortions under the Emergency Medical Treatment and Active Labor Act (EMTALA).
EMTALA is a federal law to ensure that emergency rooms provide care to patients in critical need of medical care who are uninsured or otherwise unable to pay. EMTALA explicitly requires hospitals to provide treatment to stabilize emergency medical conditions for everyone, including both a “pregnant woman” and — significantly — her “unborn child”. EMTALA specifically references the “unborn child” four times and never references “abortion”.
As reported by Council for Life, the U.S. Supreme Court heard oral arguments last year in a case brought by the State of Idaho against the U.S. Government asserting that EMTALA should not usurp Idaho’s abortion ban. SCOTUS did not rule on the merits, but instead remanded the case to the Ninth Circuit Court of Appeals for further consideration.
The most recent action by the Trump Administration affirms the statutory language that EMTALA protects both the “pregnant woman” and the “unborn child” and brings clarity to emergency room doctors across the country. Therefore, in states with abortion bans such as Texas, emergency room doctors no longer need to feel forced to perform abortions that would circumvent their state’s life-affirming laws.
(See Council for Life News HERE and Department of Health and Human Services and Centers for Medicare & Medicaid Services Press Release HERE)
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