What To Know About Mifepristone After FDA Expanded Drug To Pharmacies

Topline

The Food and Drug Administration changed its regulations on Tuesday to now make it possible for abortion pills to be dispensed by retail pharmacies, further expanding access to medication abortion, as the drugs have become a more prominent abortion method in the wake of the Supreme Court overturning Roe v. Wade.

The abortion-inducing drug mifepristone can now be dispensed at pharmacies that choose to provide … [+] it, the FDA said Tuesday.

Corbis via Getty Images

Key Facts

Mifepristone is one of two drugs that’s taken to terminate a pregnancy—it stops a pregnancy, and then a second drug, misoprostol, induces contractions to expel the tissue—and it is approved for use up to 10 weeks into a pregnancy, though in practice it’s often used until weeks 12 or 13.

The drug must be prescribed and cannot be obtained over the counter, and historically it’s only been available in-person from a physician or clinic certified to prescribe mifepristone, or more recently, prescribed through telehealth appointments and dispensed through mail-order pharmacies approved to supply the drug.

The FDA finalized new regulations Tuesday that now allow mifepristone to also be dispensed at brick-and-mortar retail pharmacies after being prescribed by a medical provider—though only after those pharmacies become certified to dispense it and agree to certain criteria, which the New York Times reports includes keeping the names of physicians who prescribe the drug confidential.

The fact that pharmacies have to opt-in to dispensing mifepristone and obtain a certification means it’s still unclear when the drug will become available at pharmacies and where it will be carried (misoprostol, also used for other medical conditions, has already been available at pharmacies).

Pharmacies are most likely to carry mifepristone in states where abortion is still broadly legal: Alaska, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Washington, D.C.

They’re least likely to carry abortion-inducing drugs in states where abortion is banned in nearly all cases, including Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, South Dakota, Tennessee, Texas, West Virginia, Wisconsin and Georgia (where it’s only banned after six weeks into a pregnancy).

Abortion is also legal as of now in Arizona, Indiana, North Dakota, Ohio, South Carolina, Utah and Wyoming—but only because courts have temporarily blocked abortion bans in those states, so pharmacies could still be hesitant to become certified, given that abortion could become illegal through a subsequent court ruling.

What We Don’t Know

Exactly which pharmacies will decide to carry abortion pills. Major pharmacy chains Walgreens and CVS have not yet responded to requests for comment on whether they intend to seek certification, though a Walgreens spokesman told the Times the company would review the FDA regulations and “continue to enable our pharmacists to dispense medications consistent with federal and state law.” Pharmacies may be skittish to dispense abortion pills given the broader political climate around abortion and threats of legal repercussions, particularly in states where there are at least some restrictions on the procedure. Some pharmacies came under fire after the Supreme Court’s abortion ruling for even refusing to give out medications for other conditions, like autoimmune diseases, because they could be used to induce a miscarriage. An official at Danco, one of two pharmaceutical companies that manufactures mifepristone, also suggested to the Times that independent pharmacies outside of major chains will likely end up carrying mifepristone first, as it might be logistically easier for them to comply with the FDA requirements to get certified.

Big Number

53%. That’s the percentage of all abortions in the U.S. that were medication abortions in 2020, the most recent year for which data is available, according to the pro-abortion rights Guttmacher Institute. Research has consistently shown medication abortion to be highly safe and 99.6% effective in terminating a pregnancy, with only 0.4% of medical abortions resulting in serious complications. The FDA reports only 28 deaths have been reported in patients “associated with mifepristone” between September 2000 and June 2022, though it notes it’s not clear if those deaths were actually caused by mifepristone, as they may have been due to other factors.

Key Background

Medication abortion through mifepristone and misoprostol was first approved by the FDA in 2000. Though widely used even when abortion was legal throughout the U.S., the abortion drugs have gained attention in the wake of the Supreme Court overturning Roe v. Wade in June, as they’re an easier way for patients in states where the procedure is banned to more easily obtain an abortion as clinics providing surgical abortions have shut down. The wave of state-level bans on abortion has prompted new tactics to make abortion pills available, such as mail-order services—and mail-forwarding services that can help skirt state bans—and abortion providers setting up mobile clinics on the borders of states where abortion is outlawed. The FDA’s expansion of mifepristone to retail pharmacies and the DOJ’s opinion on mailing the pills are part of the Biden Administration’s broader efforts to blunt the impact of the Supreme Court’s ruling, as the administration has pointed to medication abortion and the fact the FDA has authorized abortion pills for use nationwide as a key way of counteracting state bans.

Surprising Fact

While it’s unlikely that pharmacies in states that outlaw abortion will carry abortion pills—even as abortions can be allowed in narrow circumstances like medical emergencies—the Justice Department clarified Tuesday that the drugs still can be mailed to those states under federal law. Under the Comstock Act of 1873, which restricts the mailing of items used to “produc[e] abortions,” mifepristone can legally be mailed through the U.S. Postal Service or private carriers like UPS or FedEx, the DOJ said in a legal opinion, as long as the sender believes the drug will be used in a legal way. That could still be the case even in states where abortion is banned, such as if the pills are used for a medical emergency or if the drug is actually administered in a different state where abortion is legal, the Biden Administration said. That being said, while the DOJ’s opinion will serve as a legal shield to ward off challenges against abortion pills being mailed under federal law, it’s still possible that people who mail abortion pills could face legal repercussions under state laws. That’s particularly the case in states that specifically ban the mailing of abortion pills, such as Arizona, Indiana, Oklahoma and Texas.

What To Watch For

Anti-abortion advocates filed a lawsuit in November that challenges the legality of abortion pills nationwide and asks a court to force the FDA to revoke its approval of mifepristone and misoprostol, arguing that the agency didn’t have the authority to approve the drugs in the first place. The lawsuit, filed in Texas, has been assigned to a Trump-appointed judge who could be sympathetic to the challengers, though any ruling against the FDA would be certain to be appealed. A ruling on whether to at least temporarily block the abortion drugs’ approval—which would stop them from being prescribed altogether—while the case moves forward could come as soon as February.