What The FDA Rule Change On Abortion Pills Means In Wisconsin

WISCONSIN — Despite the recent Food and Drug Administration rule change to broaden abortion pill access across much of the country, accessing elective abortions in Wisconsin will remain largely banned since Roe v. Wade was overturned, pro-abortion rights advocates said this week.

In a tweet Wednesday, Planned Parenthood Advocates of Wisconsin said enforcement of the state's 1849 abortion law remains unclear, meaning elective abortions remain suspended. Additionally, state law would prohibit mailing and pharmacy pick-up of the medication in question, even if providers were suddenly able to give abortion services, PPAWI wrote.

More than half of U.S. abortions are now done with pills rather than surgery, according to the Guttmacher Institute, a research and policy group that supports abortion rights.

In Wisconsin, state law requires medication abortion to be provided by a licensed physician and the prescribing physician has to be in the presence of the patient, according to the Guttmacher Institute.

The FDA on Tuesday finalized a rule change that would make abortion pills available to more pharmacies, including large chains and mail-order companies, as well as brick-and-mortar stores, as long as they complete a certification process.

The criminal law which largely bans abortion in Wisconsin is currently in the midst of a lawsuit from Wisconsin Governor Tony Evers and Attorney General Josh Kaul, both Democrats. The suit argued that the 1800s law conflicts with other laws, and "the Wisconsin people deserve clarity."

Whether pharmacies go through the process that will allow them to dispense the pills where allowed remains to be seen. Two of the country’s biggest retail pharmacies, CVS and Walgreens, have only said that they are reviewing the rule change, The Washington Post reported.

The FDA change was partially implemented last year when the Biden administration said it would no longer enforce long-standing requirements that women pick up the medicine in person.

According to the Guttmacher Institute:

• Twenty-nine states require that medication abortion be administered by physicians;
• Two states ban abortion pills after a specific point in pregnancy;
• Eighteen states prohibit telemedicine-prescribed abortion pills and require that the clinician be physically present when the medication is administered.

Legal experts expect years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.

See also: Wisconsin Abortion Ban Challenged In Lawsuit From Kaul, Evers

For more than 20 years, the FDA labeling had limited dispensing to a subset of specialty offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said a new scientific review by agency staff supported easing access, concurring with numerous medical societies that had long said the restriction wasn't necessary.

Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs.

Danco Laboratories, which sells branded Mifeprex, said in a statement the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” with another option for prescribing the drug.

The American College of Obstetricians and Gynecologists called the update an “important step” forward.

“Although the FDA’s announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug,” the group said in a statement.

The FDA in 2000 approved mifepristone to terminate pregnancies of up to 10 weeks, when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.

Bleeding is a common side effect, though serious complications are very rare. The FDA says more than 3.7 million U.S. women have used mifepristone since its approval.

Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the case of excessive bleeding. Pharmacies that dispense the pills also need a certification.

The Associated Press contributed reporting.