What we know and what we don't about the future of access to abortion pills

Nationwide access to mifepristone, one of the two pills involved in a medication abortion, hangs in the balance after a federal judge in Texas ruled last week that the Food and Drug Administration’s approval of the drug would be put on pause following a seven-day window for the government to appeal.

The Justice Department then appealed U.S. District Court Judge Matthew Kacsmaryk’s decision to the 5th Circuit Court of Appeals, which decided Wednesday night to partially block the ruling.

The court granted the DOJ's emergency request to put on hold part of Kacsmaryk's decision that suspended the FDA's original approval of mifepristone, which dates to 2000. But the three-judge panel said a separate part of his decision, which suspends subsequent changes the FDA made to the drug’s approved use, can go into effect.

Further appeals are ahead, and abortion clinics are still readying contingency plans in case mifepristone’s FDA approval is suspended later on.

Here is what is known and still unknown about the future of mifepristone access.

Why does this case determine mifepristone access nationwide instead of state by state?

When the Supreme Court overturned Roe v. Wade, it gave states the authority to decide whether to ban or protect abortion access.

But this lawsuit, filed by a coalition of anti-abortion groups called the Alliance for Hippocratic Medicine, seeks to overturn the FDA’s approval of mifepristone, which applies nationwide. The suit alleges that the agency did not adequately evaluate mifepristone’s safety before it greenlit the drug in 2000, and also argues the FDA should not have made the medication accessible via telehealth.

Kacsmaryk’s ruling on Friday was a response to a request from the plaintiffs to pause access to mifepristone while the case proceeds. The Justice Department then filed an emergency request to the 5th Circuit Court on Monday to put Kacsmaryk’s decision on hold, and that was granted in part on Wednesday.

What exactly did the Court of Appeals decide?

The 5th Circuit Court blocked Kacsmaryk's order to suspend mifepristone's original FDA approval. But it allowed the part of his decision suspending more recent changes made in 2016, 2019 and 2021 to stand.

That could mean that by the end of Friday, access to mifepristone would look much the way it did prior to 2016. The changes the FDA made at that time extended the window in which mifepristone could be used to terminate pregnancies from seven weeks’ gestation to 10 weeks. The agency also reduced the number of in-person visits that patients were required to make from three to one.

In 2019, the FDA approved a generic form of the drug. And in 2021, it removed a requirement that mifepristone be dispensed only in clinics, medical offices and hospitals, thereby allowing the drug to be administered via telehealth and sent by mail.

The 5th Circuit said Wednesday that the plaintiffs could legally challenge those 2016, 2019 and 2021 revisions but had waited too long to challenge the 2000 approval.

Much more legal fighting may be in store. The plaintiffs’ lawyers said they have "no immediate plans" to ask the Supreme Court to overrule the 5th Circuit's decision. But the Justice Department said it would appeal and request that the Supreme Court completely block Kacsmaryk’s ruling.

What does the court's latest decision mean for mifepristone access?

Mifepristone is still available in the 36 states that legally allow some form of medication abortion. But the 5th Circuit Court's decision means that access could become significantly more restricted as early as Friday, the deadline Kacsmaryk set for his decision to take effect.

If the pause on the FDA's changes since 2016 does take effect, patients would need to obtain mifepristone in person before seven weeks' gestation. Around 43% of medication abortions in 2020 happened at seven weeks’ gestation or later, according to an NBC News analysis of data from the Centers for Disease Control and Prevention. A 2021 survey found that about one in five pregnant people discover their pregnancy after seven weeks.

But providers could still prescribe mifepristone off-label beyond seven weeks based on safety and efficacy data, according to Planned Parenthood.

If mifepristone access is ultimately blocked, what options remain for people seeking to terminate pregnancies?

The approved regimen for a medication abortion involves two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions.

If mifepristone is no longer available at some point, most abortion clinics plan to use misoprostol alone to terminate pregnancies. Studies have shown that misoprostol’s success rates generally range from 80% to 95%, whereas the two-drug combo can be up to 99.6% effective.

Both drugs are safe: One analysis found that misoprostol had a 0.7% risk of major complications, whereas the two-pill regimen has a slightly lower risk. But taking just misoprostol may cause more intense side effects, such as nausea, diarrhea, chills, vomiting or cramping.

Surgical abortions are still an option in states where abortion is legal. They are more invasive than pills and involve anesthesia or sedation, but are slightly more effective and take less time. A medication abortion takes several days.

Surgical abortions can also be more expensive. Though costs vary based on insurance, the average cost of a medication abortion at Planned Parenthood is around $580, compared with $600 to $2,000 for a surgical abortion depending on the stage of pregnancy.

What options would the FDA have if its approval of mifepristone gets overturned in this case?

If the FDA’s approval of mifepristone is revoked down the line, access to the drug would not be immediately cut off nationwide, but anyone involved in manufacturing or distributing it could face legal risk.

The FDA, though, has broad authority over enforcement so could choose not to take action against companies that sell or distribute the drug.

Legal experts said it’s possible the FDA would have to order Danco Laboratories, the maker of mifepristone, to stop manufacturing the drug, meaning supply could become limited. Massachusetts and Washington are stockpiling mifepristone in case supply becomes an issue.

Danco could also apply again for FDA approval, but it’s unclear what data would be required to support a new application, given the unprecedented nature of the lawsuit and Kacsmaryk’s decision. Health policy experts aren’t sure if Danco would need to apply for approval under a new indication, submit new trial data, or if the company could rely on data from the 20 years the drug has been on the market.

Kirsten Moore, director of the Expanding Medication Abortion Access Project, said it could take several years for the FDA to approve mifepristone again, with at least 10 months for the review process alone.

What’s the deal with the conflicting order from a federal judge in Washington?

Less than an hour after Kacsmaryk’s ruling last week, a federal judge in Washington state ordered the FDA to maintain the status-quo availability of mifepristone in 17 states and Washington, D.C. while a different lawsuit over abortion pills plays out. In that case, a group of attorneys general alleged that the FDA’s current restrictions on distributing mifepristone unnecessarily hinder access.

Legal experts said the fact that the Texas and Washington decisions conflict could help expedite the case to the Supreme Court.

“It sort of puts the fire under all courts in the country to resolve the conflict as soon as possible,” said Khiara M. Bridges, a law professor at the University of California, Berkeley.

What are the broader implications of this lawsuit beyond abortion pills?

A victory for the plaintiffs could undermine the entire drug approval process in the U.S. and open the floodgates for legal challenges to vaccines or other essential medications disputed by certain groups, legal experts said. Reversing FDA approval, they added, could disincentivize pharmaceutical companies from investing in research and development for new treatments or therapies.

“This is opening the door to basically anybody challenging any drug that they disapprove of on the theory that somebody might get hurt,” said Wendy Parmet, director of the Center for Health Policy and Law at Northeastern University.

Dozens of pharmaceutical stakeholders, including companies and executives, filed an amicus brief on Tuesday asserting that the Kacsmaryk’s decision would delay patient access to life-saving medications and make it more difficult to bring new drugs to market. A day earlier, more than 200 pharmaceutical executives signed an open letter criticizing the judge for undermining the FDA’s authority to approve and regulate safe, effective medicines.

Why were the plaintiffs able to challenge the FDA in the first place?

Kacsmaryk determined last week that the FDA's regulatory changes since 2016 opened up mifepristone’s entire approval to new challenges. The 5th Circuit, however, did not find grounds for such a broad preliminary injunction.

The anti-abortion doctors involved in the suit say that treating patients for the side effects of abortion pills has exposed them to allegations of malpractice and potential liability, placed stress on them in emergency situations and taken up medical resources that could be used for other purposes.

But lawyers for the FDA and Danco have argued that the plaintiffs did not sufficiently demonstrate that FDA’s approval of mifepristone harmed them.

“No one denies that there are adverse consequences, adverse effects to any medication, including any over-the-counter painkiller or cold medication. That those people might end up in these plaintiffs’ offices and somehow it will affect these doctors’ ability to practice and their relationship with their patients — that’s just absurd,” Parmet said.

What happens from here with the larger lawsuit?

The current fight is over an early step in the legal process: the request for a preliminary injunction. Once this particular appeals process ends, Kacsmaryk could decide to hold a trial with witness testimony or to issue a summary judgment right away. If the Justice Department loses the case, it could appeal to the 5th Circuit Court, then the Supreme Court.

Parmet said the battle over Kacsmaryk’s injunction order is essentially a preview of the larger legal battle ahead, though new debates could arise as the lawsuit is adjudicated.