WASHINGTON (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.
The Supreme Court on June 24 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.
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.
“Today I am directing the Department of Health & Human Services to take steps to ensure these critical medications are available to the fullest extent possible,” Mr. Biden said in remarks from the White House.
The pill, mifepristone, is used in combination with a second drug called misoprostol to induce an abortion up to 10 weeks into a pregnancy and is heavily restricted – only available through a certified doctor’s prescription. Abortion rights activists have stepped up calls to make it available for anyone to buy 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 Mr. Biden nor Mr. 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 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 Ms. 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.
The agency now allows 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 already restrict its use.
The White House has already 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 pregnant women to access the pills in states that seek to restrict their use. For example, they could more easily be mailed to a patient 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.