The Biden administration’s efforts to loosen access to medication abortion pills are running into a headwall of opposition in dozens of states, threatening to put the drugs out of reach for many patients.
The Food and Drug Administration (FDA) earlier this month said it will allow U.S. retail pharmacies to offer abortion pills directly to patients with a prescription in states where abortion is legal, a major step forward in easing access that had been demanded by reproductive rights activists.
Medication abortion has been available in the United States since 2000, when the FDA approved the use of mifepristone for early nonsurgical abortion. It has become an increasingly common method for ending pregnancies, especially in the wake of the Supreme Court overturning Roe v. Wade, and accounts for more than half of all abortions in the country.
But many states with strict abortion bans also limit the availability of mifepristone, either through restrictions on who can prescribe and dispense the pill or outright bans.
According to the Guttmacher Institute, an abortion rights group that tracks state restrictions,18 states require the clinician providing a medication abortion to be physically present when the medication is administered, essentially prohibiting the use of telemedicine to prescribe medication for abortion.
Texas prohibits the use of medication abortion starting at seven weeks of pregnancy, while Indiana bans its use at 10 weeks. The FDA has approved mifepristone for use up to 10 weeks.
“We have decades of evidence that medication abortion and mifepristone in particular is safe, it is effective, and so the FDA did what it’s designed to do. It looked at the evidence and made a decision,” said Jamila Perritt, an obstetrician-gynecologist in Washington, D.C., and president and CEO of Physicians for Reproductive Health.
“The challenge is that access to abortion, and medication abortion specifically, is not solely tied to medical care or medical decision making in this country,” Perritt said.
Immediately after Roe v. Wade was overturned in June, Attorney General Merrick Garland said the Justice Department will protect the right to an abortion, including medication abortion.
“In particular, the FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Garland said.
Ahead of the 50th anniversary of the Roe v. Wade decision, Health and Human Services Secretary Xavier Becerra joined advocacy groups to talk about the path forward.
He said the Biden administration was committed to protecting and expanding access to reproductive health care, including birth control and abortion.
“The president and the vice president have taken an all-hands-on-deck approach to protecting and expanding access to reproductive care that includes abortion care for everyone,” Becerra said during a press briefing. “But we can’t completely fix this on our own.”
In most instances, federal law takes precedence over state laws. Under that logic, states shouldn’t be able to restrict mifepristone because it is a federally approved drug.
In one of the more recent examples, Massachusetts in 2014 tried to ban the FDA-approved opioid Zohydro. The manufacturer sued, and a federal district court struck down the state’s restrictions.
But it’s not clear if federal law takes precedence in states with abortion bans, and so far, the government has not tried to put that theory to the test.
“This is a somewhat unique situation. States don’t typically try to ban drugs that the FDA approved,” said Rachel Rebouché, dean of Temple University Beasley School of Law.
Rebouché said states have the power to regulate the practice of medicine, but there is a question of intent.
“So in states banning mifepristone or trying to regulate it … are they making a judgment about the safety and efficacy or are they banning it because of moral grounds?” she asked.
Rebouché said the federal government could be the one that brings a lawsuit against state restrictions on mifepristone, but that could open the FDA up to an unwanted challenge over the limit of its power.
Marc Scheineson, a partner at law firm Alston & Bird and former associate FDA commissioner, said it appears the administration is willing to let others, like advocacy groups and possibly drug manufacturers, test the litigation waters
“I suspect that [the administration] wants the law to become a little bit more mature, to see in these early skirmishes you know, how the courts are viewing it,” Scheineson said. “As a last resort, they would kind of proceed. But let’s see first whether the state statutes would be struck down in cases brought by private litigants.”
The Department of Health and Human Services did not respond to questions about if it would challenge state restrictions.
Legal experts and advocates said the patchwork of laws across states will continue until a court steps in, creating uncertainty for patients and providers.
“Health care professionals on the ground are really being subjected to an incredibly complex mosaic of laws and considerations as a result of a concerted effort by certain states and certain state attorneys general to deprive people of federal protections,” said Skye Perryman, president and CEO of Democracy Forward, a legal advocacy group.
After the FDA announced the policy change allowing pharmacists to dispense mifepristone, CVS and Walgreens said their stores would seek to do so, but only in certain states.
Pharmacies in states with near-total abortion bans would not be eligible. Some states also mandate that the pills must be dispensed in-person by the physician who prescribed them.
“We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network … and will dispense these consistent with federal and state laws,” a Walgreens spokesman said.
Perritt, of Physicians for Reproductive Health, said regardless of state restrictions on abortion procedures or pills, she is most concerned about the most vulnerable people.
“The reality is that whatever the states do, whatever the federal government does, people with means and resources will always be able to access abortion. It was like that before Roe was decided in ’73. It was like that during the 40 plus years that Roe was around, and we will continue to see that happen in this current iteration,” Perritt said.
“So what we’re talking about is the brunt of the restrictions and barriers really falling on those who are already marginalized from care,” she added.