Analysis: Abortion pills over the counter? Experts see big hurdles in widening U.S. access

Aspira Women's Health

24/06/2022 19:24

(Adds comments from Biden and Becerra)
    By Ahmed Aboulenein
    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.  urn:newsml:reuters.com:*:nL1N2YB15Z
     Many U.S. states are expected to severely limit or outright
ban abortions following the Supreme Court ruling. President Joe
Biden's administration is considering options to increase access
to so-called medication abortions, which can be administered at
home.  urn:newsml:reuters.com:*:nL2N2X22W7
    "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," Biden said in remarks
from the White House.
    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.
    "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 was
committed to ensuring 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
according to medical and regulatory experts interviewed by
Reuters. They said drugmakers would need to conduct new 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 conducting the research. Should they
do so, any U.S. Food and Drug Administration (FDA) 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.  urn:newsml:reuters.com:*:nL1N2T13AJ
    The agency 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
U.S. 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
for women to access pills in states that restrict their use. For
example, they could more easily be mailed from a friend or
supporter in a state where they are not banned. 
    An FDA spokesperson 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 that 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
contractions.
    When taken together, the pills halt the pregnancy and prompt
cramping and bleeding to empty the uterus, a process similar to
miscarriage.
    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 mifepristone and misoprostol 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.
    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
research.
    The Charlotte Lozier Institute and Susan B. Anthony List,
which advocate against abortion, have said that the FDA decision
to relax restrictions on mifepristone ignored data on
complications and put women at risk.
    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 to prevent a pregnancy.
Approval for women 18 and over was granted in 2006 and for use
by women of all ages in 2013.
    "There was very strong support that you did not need a
prescriber," said Wood, who resigned from the FDA in 2005 over
the delay. 
    "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)
 ((ahmed.aboulenein@tr.com; +1 202-519-3051;))