FDA approves another generic abortion pill, prompting outrage from
conservatives
[October 03, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — Federal officials have approved another generic
version of the abortion pill mifepristone, a regulatory formality that
quickly triggered pushback from anti-abortion groups and politicians
aligned with the Trump administration.
Drugmaker Evita Solutions announced on its website that the Food and
Drug Administration signed off on its low-cost form of the pill, which
is approved to end pregnancies through 10 weeks.
Students for Life Action, which opposes abortion, in a statement
Thursday called the approval “a stain on the Trump presidency and
another sign that the deep state at the FDA must go.”
Republican Sen. Josh Hawley of Missouri also criticized the move in a
post on X, stating, “I have lost confidence in the leadership at FDA.”
A spokesperson for the agency said the FDA “has very limited discretion
in deciding whether to approve a generic drug," and added that FDA
officials do not “endorse any product.”
The criticism comes as Republican President Donald Trump’s top health
officials, including Health Secretary Robert F. Kennedy Jr., face
growing pressure from abortion opponents to reevaluate mifepristone,
which was approved 25 years ago and has repeatedly been deemed safe and
effective by FDA scientists.
In a letter to Republican attorneys general last month, Kennedy and FDA
Commissioner Dr. Marty Makary pledged to conduct a full review of the
drug’s safety.
Under Makary and Kennedy, the FDA has repeatedly delayed decisions on
vaccines, ultimately narrowing the terms of approval for this year's
COVID-19 shots. That type of political intervention was previously
highly unusual at the FDA, where career scientists typically make such
decisions.
The FDA approved the original version of mifepristone in 2000 and
gradually eased access over time. That included approving the first
generic pill, from drugmaker GenBioPro, in 2019.
In 2021, the FDA under Democratic President Joe Biden permitted online
prescribing and mail-order delivery of the drug, greatly expanding
access. Abortion opponents have been fighting the change ever since.
[to top of second column]
|
 Approval of generic drugs is
typically a rote process at the FDA, with multiple copycat versions
usually approved after the patent on the original drug expires. In
most cases, generic drugmakers only need to show that their drug
matches the ingredients and formula used in the original medication.
“This is exactly how our system is supposed to work, and it has
worked this way for decades," said Mini Timmaraju of Reproductive
Freedom for All. “Career scientists and civil servants at the FDA
did their jobs.”
The FDA typically approves such applications within 10 months. But
filing documents posted to the FDA’s website show that Evita
Solutions filed its application to market mifepristone four years
ago.
On its website, Evita states that it “believes that all people
should have access to safe, affordable, high-quality, effective, and
compassionate abortion care.”
The company said in an email that the drug is expected to launch in
January of next year.
Approval of a second generic is unlikely to affect access to the
pill, which is typically taken with another drug, misoprostol. The
combination accounts for roughly two-thirds of all U.S. abortions.
Mifepristone dilates the cervix and blocks the hormone progesterone,
while misoprostol causes the uterus to cramp and contract.
Access to mifepristone is restricted across large sections of the
country because of state laws that ban abortion — including
medication abortion — or impose separate restrictions on the drug’s
use. Those laws are subject to a number of ongoing lawsuits that are
winding their way through the legal system.
Restrictions on the pill are not supported by most major medical
societies, including the American Medical Association.
___
Associated Press writer Christine Fernando in Chicago contributed
reporting.
All contents © copyright 2025 Associated Press. All rights reserved
 |
