Is the 'abortion pill' restricted by state bans?

A state can't ban an FDA-approved drug but access is dwindling.

July 01, 2022, 10:43 AM

This is a MedPage Today story.

The Supreme Court's overturning of Roe v. Wade has led to increasing concerns around access to the abortion pill among patients and healthcare professionals.

Medication abortion already has a long history of strict regulation by the FDA, and many states had their own restrictions even before the Court decided on Dobbs v. Jackson Women's Health Organization last week. But as abortion rights have been returned to the states, jurisdictions that have restricted abortion will also likely restrict the medications. After the fall of Roe, nearly half of states are likely to ban abortion entirely -- many already have. The Court's decision has made medication abortion even more difficult to access in some states and outright illegal in others.

Experts say there will likely be many legal challenges around the abortion pill in the future. Here's what clinicians and patients need to know about restrictions around medication abortion.

What Is Medication Abortion?

A regimen of two drugs -- mifepristone (Mifeprex) and misoprostol (Cytotec) -- is approved by the FDA to end a pregnancy at up to 10 weeks' gestation. Patients first take mifepristone to block progesterone, which helps maintain a pregnancy. Then, they take misoprostol to induce contractions and expel the uterus of its contents.

More than half of all abortions in the U.S. are medication abortions, according to the Guttmacher Institute. While the treatment is safe and effective in terminating early pregnancies, it has been heavily regulated in the U.S. due to FDA restrictions on mifepristone.

In December 2021, the FDA relaxed some of the rules on mifepristone, allowing patients to pick up the drug at their pharmacy or receive it in the mail for the first time since it was approved in 2000. This was widely celebrated by abortion rights advocates, as studies have shown that remote access to abortion medications -- including by telemedicine -- is a safe and effective way to end a pregnancy.

Research also shows that the threat alone of the loss of access to abortion has led more patients to seek out abortion pills. A research letter published in JAMA Internal Medicine found that internet searches for the abortion pill increased 162% more than expected in the week after the draft of the Supreme Court's ruling on Dobbs was leaked in early May.

Can States Outright Ban Abortion Pills?

On Friday, U.S. Attorney General Merrick Garland said that states will not be able to restrict access to mifepristone.

"We stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care," Garland wrote in a statement. "States may not ban mifepristone based on disagreement with the FDA's expert judgment about its safety and efficacy."

However, states with very restrictive rules on abortion or outright bans will also put a halt to medication abortions.

"If a state law bans abortion broadly, that includes medication abortions," Elisabeth Smith, JD, director of state policy and advocacy at the Center for Reproductive Rights, told MedPage Today.

Some legal scholars believe that state restrictions on medication abortion are subject to preemption challenges -- meaning that federal oversight of the drug trumps state laws. Because the FDA has approved and regulates mifepristone, it may not be lawful for states to ban it.

Greer Donley, JD, assistant professor at the University of Pittsburgh School of Law, said that Garland's statement "was really a nod to the idea that state abortion bans theoretically have to have an exception that allows the dispensing of medication abortion."

"All state abortion bans are going to include medication abortion, but arguably a state can't ban an FDA-approved drug," Donley told MedPage Today.

What About Telemedicine Abortion?

Despite FDA approval of mifepristone to end a pregnancy, many states imposed their own restrictions on medication abortion even before the Dobbs decision. According to the Guttmacher Institute, 32 states require that the provider who administers a medication abortion be a physician (although the FDA allows certified providers including nurse practitioners or physician assistants to administer mifepristone). Nineteen states require the person providing a medication abortion to be present when the patient takes mifepristone, prohibiting the use of telemedicine for the procedure.

"While the FDA has said medication abortion can be provided via telemedicine and the mail, numerous states enforce laws prohibiting telemedicine for medication abortion," Smith said.

Additionally, because providers are only licensed to practice medicine in their state, those in states who have secured the right to abortion could not administer the abortion pill to patients residing in a state that banned the procedure.

"There's not currently any legal way for providers to prescribe across state lines," Donley said.

Where Else Can Patients Get Abortion Pills?

But patients in states that have banned abortion still have some options to terminate their pregnancy with medication. Plan C, an organization that connects patients to abortion pill services, is one example that helps people find international providers or other online pharmacies that will dispense the medications. Plan C directs patients to organizations such as Aid Access, an abortion pill provider based in Europe that ships abortion pills to people in the U.S. Patients can choose to consult with a provider, and self-manage their abortion at home.

"Because Aid Access is not based in the United States, U.S. enforcement -- whether private, state, or federal -- cannot reach them," Smith said. Under the Trump administration, FDA officials sent a warning letter to Aid Access in an attempt to stop them from distributing a "misbranded and unapproved new drug." Aid Access, however, did not comply, and filed a lawsuit against the FDA for violating patients' rights and placing an "undue burden" on the right to abortion.

As patients' rights to obtain a medication abortion are eroded in states with outright abortion bans, organizations such as Aid Access have preserved an alternate option.

"Certainly, the kind of cross-country care that has existed for the past 5 years is going to continue to exist, and likely become even more acceptable," Donley said.

While alternatives to obtain reproductive healthcare are available for patients who live in states that have banned abortion, abortion advocates say that efforts to eliminate medication abortion contradict evidence-based standards of care.

"Time and time again, medication abortion has been scientifically proven to be a safe and effective method to terminate a pregnancy," Smith noted.

"Restrictions against mifepristone and misoprostol are medically unnecessary and are based on misinformation," she added. "This just goes to show that restrictions on abortion have nothing to do with people's health but rather threaten the well-being of communities across the country."

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