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Abortion Pills to Be Available More Widely Under New FDA Rules

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Abortion Pills to Be Available More Widely Under New FDA Rules

Patients will be able to get the drug, called mifepristone, from bricks-and-mortar pharmacies

Mifepristone, sold as a generic or under the brand name Mifeprex, is used in combination with misoprostol in a medication abortion regimen.

By Liz Essley Whyte, WSJ

Updated Jan. 3, 2023 9:23 pm ET

The Food and Drug Administration expanded access to a drug that induces abortion, allowing bricks-and-mortar pharmacies to dispense the pills for the first time.

Under the changes the agency issued Tuesday, any pharmacy can complete and sign a short form to become certified to provide the so-called abortion pill, not just the handful of mail-order pharmacies that were permitted to ship prescriptions during the pandemic.

The moves won’t change the availability of abortion for many women. A dozen states ban abortion throughout pregnancy, and 18 require a physician to be physically present with a patient to prescribe abortion pills, effectively banning telehealth for abortions, according to the Guttmacher Institute, a nonprofit that tracks abortion statistics and supports abortion rights.

More doctors, however, may sign up to be certified to prescribe abortion pills because they will no longer need to stock and dispense the medication as well. Some women who are concerned a family member or roommate might open a mailed package of pills might feel more comfortable filling a prescription at a pharmacy.

The action will also likely deepen tensions between abortion supporters and opponents over access to the drug, which many women seeking to end their pregnancies have turned to, especially after the Supreme Court overturned Roe v. Wade last year.

“At a time when people across the country are struggling to obtain abortion-care services this modification is critically important to expanding access to medication abortion services,” said Danco Laboratories LLC, one of the companies that makes the pill.

The abortion pill, called mifepristone, is sold as a generic or under the brand name Mifeprex. It is also sometimes known as RU-486. It works by blocking a hormone necessary to sustain pregnancy.

Before the pandemic, women could get the pill only if they went to certain healthcare settings, such as a doctor’s office. During the pandemic, the FDA allowed doctors to prescribe the pill via telehealth and allowed certified mail-order pharmacies to send it to patients.

After the Supreme Court decision that overturned Roe v. Wade, attention has turned to abortion pills. WSJ’s Daniela Hernandez explains how misoprostol and mifepristone work together to terminate a pregnancy, as well as the potential side effects of a medical abortion. Illustration: David Fang

The agency said in late 2021 that it would permit telehealth abortion to continue permanently, though some states ban the practice.

Women seeking an abortion by pill take mifepristone followed by misoprostol, which causes uterine contractions. The FDA says the regimen is safe and effective up to 10 weeks in pregnancy.

Most abortions in the U.S. happen via the pill, according to the Guttmacher Institute. Several organizations that mail abortion pills, sometimes to women in states with abortion bans, have seen shipments increase since the Supreme Court’s latest abortion decision.

Aid Access, a nonprofit based in Europe that mails pills worldwide, even to states with abortion bans, said it is receiving about 4,000 requests for abortion pills a month from the U.S.

In addition to broadening access to bricks-and-mortar pharmacies, the FDA’s action cemented its earlier decision to allow telehealth abortions. The agency ended a requirement that the pill must be prescribed in person and affirmed that mail-order pharmacies could dispense the medication if certified.

The FDA made the latest changes to access to mifepristone by sending letters to manufacturers, approving their plans to alter the drugs’ safety restrictions. The agency also updated a page on its website.

“This has been a niche product for so long, and now we’re really on the cusp of making it mainstream,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project, a nonprofit that supports abortion rights.

Abortion opponents said the changes should be rolled back. “State lawmakers and Congress must stand as a bulwark against the Biden administration’s pro-abortion extremism. We hope to see the FDA do its job to protect the lives of women and put an end to chemical abortions,” said Marjorie Dannenfelser, president of SBA Pro-Life America, an antiabortion group.

Even before the FDA’s moves, mifepristone was poised to be at the center of abortion battles this year. Some state legislatures are expected to debate bills restricting or defending access to the drug. A Missouri bill, for example, would make bringing abortion-inducing drugs into the state a felony.

Abortion opponents sued the FDA in federal court late last year, seeking to overturn mifepristone’s approval. Experts expect to see more lawsuits over potential conflicts between the FDA’s power to regulate drugs and the states’ power to regulate the practice of medicine.

Also on Tuesday, the Justice Department issued an opinion saying that abortion pills can be sent through the U.S. mail, as long as the sender doesn’t intend them to be used unlawfully.

The U.S. Postal Service and the Department of Health and Human Services had asked the Justice Department to clarify an 1873 law, which had been invoked by Mississippi’s attorney general in a lawsuit last year, that prohibits mailing items that can be used to produce abortions.

—Sadie Gurman contributed to this article.

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