Analysis: Over-the-counter abortion pills? Experts see big obstacles to expanding access in the United States

ByDonald L. Leech

Jun 24, 2022

WASHINGTON, June 24 (Reuters) – A pill used to terminate teenage pregnancies is unlikely to be available without a prescription for years, if ever, experts told Reuters, as the conservative U.S. Supreme Court significantly restricted the right to abortion this week.

On Friday, the Supreme Court overturned the landmark 1973 decision Roe v. Wade who recognized the constitutional right to abortion and legalized it nationwide. The new ruling stung abortion rights advocates and was a momentous victory for Republicans and religious conservatives. Read more

Many US 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 medical abortions, which can be administered at home. Read more

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“Today, I call on the Department of Health and Human Services to take action to ensure these essential medicines 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, causes abortion up to 10 weeks into a pregnancy and is only available with a prescription from a certified physician. Abortion rights campaigners have escalated calls for it to be available in pharmacies without a prescription.

“We will double down and use every lever we have to protect access to abortion care,” Health and Human Services Secretary Xavier Becerra said in a statement, adding that the department is committed to guarantee access to “medical abortion that has been approved by the FDA for more than 20 years.”

Neither Biden nor Becerra have considered 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 should conduct new studies showing that the product’s package instructions would allow a consumer to use it safely without professional medical advice.

The two companies that manufacture the pill for the US market have shown no interest in conducting the research. If they did, any U.S. Food and Drug Administration (FDA) approval would become the target of lawsuits from abortion opponents, which could set implementation back for years, they said. said experts.

“The hard part I see is getting proof or agreement that no prescribers are needed at all,” said Susan Wood, former assistant commissioner for women’s health at the FDA.

“I personally don’t see that happening in the next two years,” said Wood, now director of the Jacobs Institute of Women’s Health at George Washington University.

THE NEXT BATTLE

Access to abortion pills should become the next big battle, as their use is harder to track. The FDA has already relaxed some restrictions, making it easier for board-certified doctors to prescribe them. Read more

The agency now allows board-certified physicians to prescribe mifepristone after a telehealth visit rather than in person. Patients can receive it by mail, making it easier for women in US states that restrict its use.

The White House has considered making abortion pills available online and in pharmacies overseas, by prescription. However, the possibility of importation has been restricted by Congress in broader drug regulation legislation.

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 sent by a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to say whether the use of over-the-counter abortion pills had been considered. A spokesperson for Danco Laboratories, a maker of mifepristone, said it does not plan to seek over-the-counter approval. GenBioPro, the second-largest maker of mifepristone for the US market, did not respond to requests for comment.

ARE THEY SECURE?

Medical abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks progesterone, the pregnancy-maintaining hormone. The second, misoprostol, induces uterine contractions.

When taken together, the pills stop pregnancy and cause cramping and bleeding to empty the uterus, a process similar to a miscarriage.

Abortion rights activists say the pills have been safe and effective for a long time, 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 an abortion.

“Medical abortion really meets all of the FDA’s criteria for an over-the-counter change,” said Antonia Biggs, associate professor at the University of California, Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of San Francisco.

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

The Charlotte Lozier Institute and Susan B. Anthony List, who advocate against abortion, said the FDA’s decision to ease 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 sex to prevent pregnancy. Approval for women 18 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 prescriber,” said Wood, who resigned from the FDA in 2005 over the delay.

“Everyone under the sun agreed except for a small group of people who somehow had huge political clout.”

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Reporting by Ahmed Aboulenein; Editing by Michele Gershberg, Aurora Ellis and David Gregorio

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