Analysis-Abortion Pills Without Prescription? Experts see major hurdles in broadening access to the US

By Ahmed Aboulenein

WASHINGTON (Reuters) – A pill used to terminate early pregnancies is unlikely to be available without a prescription for years, if ever, experts say, as the conservative-minded U.S. Supreme Court is expected to drastically curtail abortion rights in the coming weeks.

The Biden administration is considering several options to increase access to so-called drug abortions, which can be administered at home, to help women in many US states that are expected to severely restrict or completely ban abortions following the upcoming Supreme Court ruling.

The pill, mifepristone, is used in combination with a second drug called misoprostol to induce abortion up to 10 weeks after pregnancy and is highly restricted — available only with a prescription from a certified physician. Abortion rights activists have stepped up calls to make it available to everyone to buy from pharmacies without a prescription.

Medical and regulatory experts interviewed by Reuters say the process could take years. Drug manufacturers should conduct new studies showing that a consumer can safely use the product based on the directions on the package, without the guidance of a doctor or other supplier.

The two companies that make the pill for the American market have shown no interest in this. If they choose to conduct the study, any approval from the U.S. Food and Drug Administration (FDA) would become a target for lawsuits from abortion opponents that could delay implementation for years, they say.

“The hardest thing I see is getting the evidence or agreement that no prescriber is needed at all,” said Susan Wood, a former assistant commissioner for women’s health at the FDA.

“Personally, I don’t see it happening in the next few years,” said Wood, now director of George Washington University’s Jacobs Institute of Women’s Health.

The Supreme Court will soon rule on a new case that could overturn the landmark Roe v. Wade ruling that made abortion legal in the country in 1973. Last month, a leaked draft ruling suggested a majority of judges would reverse the decision. Should that happen, nearly half of the 50 US states are expected to ban or severely restrict the procedure — which would drastically limit access for millions of women.

THE NEXT BATTLE

Access to abortion pills is expected to be the next big battle as their use is harder to track. The FDA has already made it easier for certified physicians to prescribe the pills by easing some restrictions.

The agency now allows doctors certified to prescribe mifepristone to do so after a telehealth visit rather than in person, and patients can receive it in the mail, making it easier for women in US states that already restrict its use. .

The White House has already considered making abortion pills available for prescription online and at pharmacies abroad. However, the import option has already been curtailed by Congress in broader drug regulation legislation.

An over-the-counter prescription would make it much easier for pregnant women to access the pills in states that want to restrict their use. For example, they may be more easily emailed to a patient of a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to comment on whether the use of over-the-counter abortion pills has been considered. A spokesman for Danco Laboratories, a manufacturer of mifepristone, said it has no plans to seek over-the-counter approval. GenBioPro, the second maker of mifepristone for the US market, did not respond to requests for comment.

ARE THEY SAFE?

Medication abortion involves two medications, taken for a day or two. The first, mifepristone, blocks the pregnancy-supporting hormone progesterone. The second, misoprostol, causes uterine contractions.

When taken together, the pills stop the pregnancy and cause cramping and bleeding to empty the uterus, in 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 meets all the FDA criteria for an over-the-counter switch,” said Antonia Biggs, an associate professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco.

A study by Biggs and colleagues found that the majority of participants would understand an over-the-counter medication abortion. Biggs said she was not in talks with drug manufacturers about her research.

The Charlotte Lozier Institute and Susan B. Anthony List, who advocate against abortion, have said the FDA’s decision to relax restrictions on mifepristone ignored data on complications and put women at risk.

Others point to the decade-long legal battle for over-the-counter Plan B, a form of emergency contraception taken within days of intercourse to prevent a pregnancy. Approval for women 18 years and older was granted in 2006 and for use by women of all ages in 2013.

“There was very strong support that you didn’t need a prescription,” said Wood, who resigned from the FDA in 2005 because of the delay.

“Everyone under the sun agreed, except for a small group of people who had enormous political influence in one way or another.”

(Reporting by Ahmed Aboulenein; editing by Michele Gershberg and Aurora Ellis)

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