FDA Expands Abortion Pill Access For MI Women

MICHIGAN — After Michiganders voted to protect abortion rights in the state's constitution, the Food and Drug Administration made it easier for women in the state to get access to abortion pills with a prescription.

Michiganders approved Proposal 3 in last year's November elections, nullifying a 1931 state law banning abortion and protecting a woman's right to an abortion.

Gov. Gretchen Whitmer first sent a letter to the FDA in July asking for restrictions on mifepristone, a drug used to administer a medication abortion, to be lifted.

"Last year, I called on the FDA multiple times to remove burdensome restrictions on mifepristone, abortion medication that is safer than Tylenol, Viagra, and many other widely used medications," Whitmer said. "Today, I am proud to see the FDA take action. As some state governments take steps to control women’s bodies, enacting extreme laws and restrictions, we must keep finding creative ways to protect reproductive freedom including cutting red tape so women can access the care they need."

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.

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.

Whether pharmacies go through the process that will allow them to dispense the pills 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 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.

Now, the prescriptions are available via telehealth consultation with a health professional. Women can receive the pills through the mail in states where abortion pills are permitted by law. 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.

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