The latest move in the fight over the abortion pill erases years of progress in increasing access to the drug, with the leader of the country’s biggest medical body calling it a “profoundly dangerous step backwards.”
A federal appeals court said late Wednesday that the abortion pill, mifepristone, could stay on the market while the Biden administration fights a Texas judge’s ruling that the drug’s more than two-decades-old approval is invalid. But the rules under which the appeals court said the abortion pill can continue to be sold are seven years out of date and not in line with the latest medical research. That’s not by accident.
“The appeals court elevated speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive health care,” said Jack Resneck Jr., president of the American Medical Association.
Judges and lawmakers shouldn’t “ignore the substantial weight of scientific evidence from hundreds of studies and millions of patients confirming the safety and effectiveness of mifepristone, which has been used for decades in both medication abortion and miscarriage management,” Resneck said.
The appeals court is following a playbook that other conservative states have used to keep the abortion pill out of reach: Putting outdated restrictions on the drug makes it harder for people to get.
“Patients are going to bear the brunt of all of this political grandstanding,” said Ushma Upadhyay, professor and public health scientist at University of California, San Francisco. “These are people’s lives and it’s like they don’t even realize that they’re changing the life course trajectories of thousands of pregnant people across the country.”
Before Roe v. Wade was overturned last year, more than half of all abortions in the US were done by pill. But many states, in an effort to limit abortion, had their own laws governing use of the pill that were even more onerous than what the US government required. Now the federal appeals court is saying the pill can only be sold under restrictions that were deemed unnecessary by the Food and Drug Administration several years ago.
“They are still in effect, ignoring two-plus decades worth of data that has been collected, evidence that has been collected on real-world use, and just putting mifepristone back under a lock and key,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.
The abortion pill, mifepristone, has had a long history of being tightly controlled by the government in the US. Its approval in 2000 came with strict safety regulations: It was only allowed to be prescribed during the first seven weeks of pregnancy by a doctor who could do a surgical abortion and a patient needed to take the pill at the provider’s office. The FDA also required the manufacturer to conduct additional follow-up safety studies, according to a letter outlining the conditions of mifepristone’s original approval.
In 2007, a law was passed that expanded the FDA’s risk management authority, authorizing the agency to create a program now called the Risk Evaluation and Mitigation Strategy, or REMS. It was designed to ensure certain drugs that carried greater risks were dispensed under stricter conditions so people who shouldn’t take the drugs didn’t get them. Drugs like antipsychotics and opioids were subject to the rules. A few years later, the agency imposed what’s known as a “REMS” on mifepristone, which is sold by Danco Laboratories, codifying the restrictions on the drug.
Medical experts say data has proven the drug to be safe, making the REMS unnecessary. A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized, for example. After reviewing around 15 years of safety data and doing its own four-year assessment of the restrictions on the abortion pill, the agency revised its rules in 2016.
Since then — until the appeals court’s ruling this week — the FDA has allowed the drug to be used through 10 weeks of pregnancy instead of seven.
Other restrictions have changed since 2016 as well. During the early days of the Covid pandemic when people were avoiding in-person medical appointments of any kind, the FDA temporarily lifted the requirement that people go to a doctor’s office to pick up the pill in response to a lawsuit from a major medical organization. The Trump administration swiftly fought the agency on that and in the end, the Supreme Court sided with Trump and prevented mail-order pills.
President Joe Biden, in 2021, ultimately directed the FDA to allow mail-order pills. Nearly nine out of 10 Americans lived in a county without an abortion clinic at that time.
Later that year, in response to a different lawsuit, the FDA permanently lifted the in-person dispensing requirement but left other restrictions in place like requiring patients to sign an agreement form and permitting prescriptions only from certified health-care providers, rules that aren’t in place for many other drugs. The ACLU said the remaining rules are an “unnecessary hurdle that blocks many patients from accessing this medication from their own qualified health care providers.”
The agency had faced pressure for years from medical bodies and advocacy groups to loosen restrictions on the abortion pill. The American Medical Association, American College of Obstetricians and Gynecologists and American Academy of Family Physicians have repeatedly called for the FDA to remove the safety requirements. Even the FDA’s own commissioner who oversaw the agency when the pill was approved argued that the REMS on mifepristone should be removed. In a 2019 New England Journal of Medicine opinion piece that she co-wrote, Jane Henney said “the evidence available today indicates that the current restrictions are overly prescriptive.”
Earlier this year, the FDA finally allowed the pill to be dispensed at retail pharmacies for the first time in its 23 years on the market. Walgreens Boots Alliance Inc., CVS Health Corp. and Rite Aid Corp. have said they’ll go through the certification process to fill abortion pill prescriptions in the states where it’s legal. The chains have already been targeted by anti-abortion protesters.
Even with this new change, the FDA added a new rule: Pharmacies have to get certified before they can dispense the medication, a restriction that applies to 57 drugs. The agency currently regulates more than 20,000 prescription drugs.
