Project 2025 on the Abortion pill
This from the same Health and Human Services document that produced the general abortion language.
Abortion Pills. Abortion pills pose the single greatest threat to unborn children
in a post-Roe world. The rate of chemical abortion in the U.S. has increased
by more than 150 percent in the past decade; more than half of annual abortions
in the U.S. are chemical rather than surgical.
The abortion pill regimen is typically a two-part process. The first pill, mifepristone,
causes the death of the unborn child by cutting o! the hormone progesterone,
which is required to sustain a pregnancy. The second pill, misoprostol, causes contractions
to induce a delivery of the dead child and uterine contents, usually into a
toilet at home. The abortion-pill regimen is currently approved for up to 70 days
(10 weeks) into pregnancy and before Biden was subject to a heightened safety
restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires
an in-person visit with a physician who can check for dangerous contraindications
such as ectopic pregnancies and can advise the mother seeking an abortion of the
risks of chemical abortion, including hemorrhaging, and what to do in such circumstances.
Chemical abortion has been found to have a complication rate four
times higher than that of surgical abortion.
Since its approval more than 20 years ago, mifepristone has been associated with
26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands
more adverse events, but that number does not account for all complications. Of
course, this does not count the hundreds of thousands to millions of babies whose
lives have been unjustly taken through chemical abortion. FDA should therefore:
l Reverse its approval of chemical abortion drugs because the
politicized approval process was illegal from the start. The FDA
failed to abide by its legal obligations to protect the health, safety, and
welfare of girls and women. It never studied the safety of the drugs
under the labeled conditions of use, ignored the potential impacts of the
hormone-blocking regimen on the developing bodies of adolescent girls,
disregarded the substantial evidence that chemical abortion drugs cause
more complications than surgical abortions, and eliminated necessary
safeguards for pregnant girls and women who undergo this dangerous drug
regimen. Furthermore, at no point in the past two decades has the FDA ever
acknowledged or addressed federal laws that prohibit the distribution of
abortion drugs by postal mail; to the contrary, the FDA has permitted and
actively encouraged such activity.
Now that the Supreme Court has acknowledged that the Constitution
contains no right to an abortion, the FDA is ethically and legally obliged to
revisit and withdraw its initial approval, which was premised on pregnancy
being an “illness” and abortion being “therapeutically” effective at treating
this “illness.” The FDA is statutorily charged with guaranteeing the
safety and efficacy of drugs and therefore should withdraw this drug that
is proven to be dangerous to women and by definition fatally unsafe for
unborn children.
As an interim step, the FDA should immediately restore the REMS by removing
the in-person dispensing requirement to eliminate dangerous tele-abortion and
abortion-by-mail distribution.
Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion
industry that allows it to expand far beyond brick-and-mortar clinics and into=
pro-life states that are trying to protect women, girls, and unborn children from
abortion. The FDA should therefore:
l Reinstate earlier safety protocols for Mifeprex that were mostly
eliminated in 2016 and apply these protocols to any generic version
of mifepristone. A bare-minimum policy of limiting abortion pills to the
pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person
dispensing requirement, and returning to requiring prescribers to report all
serious adverse events, not just deaths, to the drug sponsor would increase
women’s health and safety.
Il Address weaknesses in the current FAERS (FDA Adverse Events
Reporting System). The Administration and policymakers should ensure
that health care workers, particularly those in hospitals and emergency rooms,
report abortion pill complications. Women who experience complications
from abortion pills typically go to an emergency room, not to the abortion pill
prescriber, so putting the onus of reporting on the prescriber who typically has
no idea that a complication has occurred means that the FAERS is seriously
undercounting adverse events. Submitting an adverse event to the database
should be a quick and e"cient process for busy health care practitioners.
Currently, providers report that the process is di"cult and convoluted.
IIl Implement a policy of transparency about inspections of the abortion
pill’s sponsors, Danco and GenBioPro, as well as facilities that
manufacture the pills. The FDA should respond to congressional requests
and Freedom of Information Act (FOIA) requests about inspections,
compliance, and post-marketing safety in a timely manner.
lV Stop promoting or approving mail-order abortions in violation of
long-standing federal laws that prohibit the mailing and interstate
carriage of abortion drugs.16
Abortion Pills. Abortion pills pose the single greatest threat to unborn children
in a post-Roe world. The rate of chemical abortion in the U.S. has increased
by more than 150 percent in the past decade; more than half of annual abortions
in the U.S. are chemical rather than surgical.
The abortion pill regimen is typically a two-part process. The first pill, mifepristone,
causes the death of the unborn child by cutting o! the hormone progesterone,
which is required to sustain a pregnancy. The second pill, misoprostol, causes contractions
to induce a delivery of the dead child and uterine contents, usually into a
toilet at home. The abortion-pill regimen is currently approved for up to 70 days
(10 weeks) into pregnancy and before Biden was subject to a heightened safety
restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires
an in-person visit with a physician who can check for dangerous contraindications
such as ectopic pregnancies and can advise the mother seeking an abortion of the
risks of chemical abortion, including hemorrhaging, and what to do in such circumstances.
Chemical abortion has been found to have a complication rate four
times higher than that of surgical abortion.
Since its approval more than 20 years ago, mifepristone has been associated with
26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands
more adverse events, but that number does not account for all complications. Of
course, this does not count the hundreds of thousands to millions of babies whose
lives have been unjustly taken through chemical abortion. FDA should therefore:
l Reverse its approval of chemical abortion drugs because the
politicized approval process was illegal from the start. The FDA
failed to abide by its legal obligations to protect the health, safety, and
welfare of girls and women. It never studied the safety of the drugs
under the labeled conditions of use, ignored the potential impacts of the
hormone-blocking regimen on the developing bodies of adolescent girls,
disregarded the substantial evidence that chemical abortion drugs cause
more complications than surgical abortions, and eliminated necessary
safeguards for pregnant girls and women who undergo this dangerous drug
regimen. Furthermore, at no point in the past two decades has the FDA ever
acknowledged or addressed federal laws that prohibit the distribution of
abortion drugs by postal mail; to the contrary, the FDA has permitted and
actively encouraged such activity.
Now that the Supreme Court has acknowledged that the Constitution
contains no right to an abortion, the FDA is ethically and legally obliged to
revisit and withdraw its initial approval, which was premised on pregnancy
being an “illness” and abortion being “therapeutically” effective at treating
this “illness.” The FDA is statutorily charged with guaranteeing the
safety and efficacy of drugs and therefore should withdraw this drug that
is proven to be dangerous to women and by definition fatally unsafe for
unborn children.
As an interim step, the FDA should immediately restore the REMS by removing
the in-person dispensing requirement to eliminate dangerous tele-abortion and
abortion-by-mail distribution.
Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion
industry that allows it to expand far beyond brick-and-mortar clinics and into=
pro-life states that are trying to protect women, girls, and unborn children from
abortion. The FDA should therefore:
l Reinstate earlier safety protocols for Mifeprex that were mostly
eliminated in 2016 and apply these protocols to any generic version
of mifepristone. A bare-minimum policy of limiting abortion pills to the
pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person
dispensing requirement, and returning to requiring prescribers to report all
serious adverse events, not just deaths, to the drug sponsor would increase
women’s health and safety.
Il Address weaknesses in the current FAERS (FDA Adverse Events
Reporting System). The Administration and policymakers should ensure
that health care workers, particularly those in hospitals and emergency rooms,
report abortion pill complications. Women who experience complications
from abortion pills typically go to an emergency room, not to the abortion pill
prescriber, so putting the onus of reporting on the prescriber who typically has
no idea that a complication has occurred means that the FAERS is seriously
undercounting adverse events. Submitting an adverse event to the database
should be a quick and e"cient process for busy health care practitioners.
Currently, providers report that the process is di"cult and convoluted.
IIl Implement a policy of transparency about inspections of the abortion
pill’s sponsors, Danco and GenBioPro, as well as facilities that
manufacture the pills. The FDA should respond to congressional requests
and Freedom of Information Act (FOIA) requests about inspections,
compliance, and post-marketing safety in a timely manner.
lV Stop promoting or approving mail-order abortions in violation of
long-standing federal laws that prohibit the mailing and interstate
carriage of abortion drugs.16
