WASHINGTON, June 24 (Reuters) - A pill used to terminate
early pregnancies is unlikely to become available without a
prescription for years, if ever, experts told Reuters, as the
conservative-leaning U.S. Supreme Court dramatically curbed
abortion rights this week.
The Supreme Court on Friday overturned the landmark 1973 Roe
v. Wade ruling that recognized the constitutional right to an
abortion and legalized it nationwide. The new ruling stung
abortion rights advocates and was a momentous victory to
Republicans and religious conservatives.
The pill, mifepristone, in combination with a second drug
called misoprostol, induces an abortion up to 10 weeks into a
pregnancy and is only available through a certified doctor's
prescription. Abortion rights activists have stepped up calls to
make it available at pharmacies without a prescription.
Many U.S. states intend to severely limit or outright ban
abortions after the ruling. The White House is considering
options to increase access to so-called medication abortions,
which can be administered at home.
"Today I am directing the Department of Health and Human
Services to take steps to ensure these critical medications are
available to the fullest extent possible," President Joe Biden
said at the White House on Friday.
"We will double down and use every lever we have to protect
access to abortion care," Secretary of Health and Human Services
Xavier Becerra said in a statement, adding the department would
ensure access to "medication abortion that has been approved by
the FDA for over 20 years."
Neither Biden nor Becerra addressed making the pills
available over-the-counter, a process that could take years,
medical and regulatory experts told Reuters. They said
drugmakers would need to conduct studies showing directions on
the product's packaging would enable a consumer to safely use it
without professional medical guidance.
The two companies that make the pill for the U.S. market
have shown no interest in the process. Should they do, any U.S.
Food and Drug Administration approval would become a target for
lawsuits from abortion opponents that could delay implementation
for years, experts said.
"The hard part that I see is getting the evidence or the
agreement that no prescriber is needed at all," said Susan Wood,
a former Assistant Commissioner for Women's Health at the FDA.
"I personally don't see it happening in the next couple of
years," said Wood, now director of George Washington
University's Jacobs Institute of Women's Health.
THE NEXT BATTLE
Access to abortion pills is expected to become the next big
battle, as their use is harder to track. The FDA has already
relaxed some restrictions, making it easier for certified
doctors to prescribe them.
It now allows certified doctors to prescribe mifepristone
after a telehealth visit rather than in-person. Patients can
receive it by mail, making it easier for women in states that
restrict its use.
The White House has considered making abortion pills
available online and from pharmacies abroad, with a
prescription. However, the import possibility has been curtailed
by Congress in broader legislation about drug regulation.
An over-the-counter designation would make it much easier to
access pills in states restricting their use. For example, they
could more easily be mailed from a friend or supporter in a
state where they are not banned.
The FDA declined to comment on whether over-the-counter use
of abortion pills has been considered. A spokesperson for Danco
Laboratories, a manufacturer of mifepristone, said it does not
plan to seek over-the-counter approval. GenBioPro, the second
maker of mifepristone for the U.S. market, did not respond to
requests for comment.
ARE THEY SAFE?
Medication abortion involves two drugs, taken over a day or
two. The first, mifepristone, blocks the pregnancy-sustaining
hormone progesterone. The second, misoprostol, induces uterine
When taken together, they halt the pregnancy and prompt
cramping and bleeding to empty the uterus, a process similar to
Abortion rights activists say the pills have a long track
record of being safe and effective, with no risk of overdose or
addiction. In several countries, including India and Mexico,
women can buy them without a prescription to induce abortion.
"Medication abortion really does meet all the FDA criteria
for an over-the-counter switch," said Antonia Biggs, associate
professor at the University of California, San Francisco's
Obstetrics, Gynecology and Reproductive Sciences department.
Sue Liebel, state policy director for anti-abortion group
Susan B. Anthony List, argued the FDA put women at risk by
relaxing restrictions on mifepristone.
"Going over-the-counter would be the most egregious action
we've ever seen the FDA do," she said. "If that does happen, we
would certainly want to try to litigate that."
FDA records show an extremely small mortality case number:
As of June 2021, there were reports of 26 deaths associated with
mifepristone out of 4.9 million people estimated to have taken
the pill since the product was approved in September 2000.
A study https://journals.lww.com/greenjournal/Fulltext/9900/Comprehension_of_an_Over_the_Counter_Drug_Facts.463.aspx
by Biggs and colleagues found that the majority of participants
would understand a medication abortion over-the-counter label.
Biggs said she was not in talks with drugmakers over her
Others point to the decade-long legal fight for
over-the-counter Plan B, a form of emergency contraception taken
within days of sexual intercourse. The FDA approved its use for
women 18 and over in 2006 and for all women in 2013.
"There was very strong support that you did not need a
prescriber," said Wood, who resigned from the FDA in 2005 over
"Everybody under the sun agreed except for a small group of
people who somehow had an enormous political influence."
(Reporting by Ahmed Aboulenein; Editing by Michele Gershberg,
Aurora Ellis and David Gregorio)