Can the FDA Stop States From Banning Abortion Pills?
The FDA could work with the Department of Justice to sue states over mifepristone bans. But should it?
If you need any more evidence that the abortion law landscape will get even more murky than we can imagine, look no further than this statement from U.S. Attorney General Merrick Garland. With more than a dozen states moving to make abortion illegal within their borders, America's top cop suggests the feds could thwart this by citing Food and Drug Administration (FDA) authority.
Reacting to last week's Supreme Court ruling overturning Roe v. Wade, Garland said "the Justice Department strongly disagrees with the Court's decision."
The Department stands "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 added. "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."
Mifepristone is part of a two-pill regimen approved by the FDA to terminate pregnancies up to 10 weeks.
States that have banned or plan to ban abortion say this prohibition applies to not just surgical procedures but also these pills, which provide what's called medical abortions. Garland's statement suggests the federal government won't let the latter happen.
"The Justice Department will use every tool at our disposal to protect reproductive freedom," said Garland. He added that "few rights are more central to individual freedom than the right to control one's own body."
That last statement is a bit ironic coming from a federal government that still criminalizes marijuana (not to mention many other drugs), routinely cooperates with local police departments to catch people having sex for money, tried to strong-arm employees of private companies into getting vaccinated, and is instituting a new war on nicotine.
But at least Garland recognizes that people have some right to control their own bodies. That's unambiguously a good thing.
Whether FDA authority should be used to stop state abortion bans is another story. Could doing so risk further politicizing the FDA, setting the stage for the agency under the next Republican administration to ban abortion pills based on moral—not safety—concerns? Does it set us up for a whole bunch of back-and-forth over the legal status of drugs depending on who is in power—thereby raising the stakes of presidential elections further? Or is this just common sense, that states can't ban drugs and devices the FDA has approved?
As it stands, the FDA has set some minimum rules regarding abortion pills and states are free to enact further restrictions.
Mifepristone was first approved by the FDA as an abortion drug in 2000 and, until not long ago, the agency said women must physically visit a medical office to have it prescribed and dispensed by a "certified provider." In July 2020, however, a federal judge temporarily suspended the in-person mandate, saying that the pandemic made it too substantial an obstacle to obtaining an abortion. And in December 2021, the FDA said it would permanently allow people to get abortion pills mailed to them after a telemedicine appointment.
This does not mean women across America are able to do so, however. At least "19 states require the clinician providing a medication abortion to be physically present when the medication is administered, thereby prohibiting the use of telemedicine to prescribe medication for abortion," according to the Guttmacher Institute. Seven such requirements were passed just last year, along with six new laws banning the mailing of abortion pills in some states.
These types of telemedicine abortion bans are already the subject of a pending federal court case.
GenBioPro Inc, which sells mifepristone, is suing over a Mississippi law banning remote prescription of abortion pills. The company argues that Mississippi's law is preempted by the FDA—that is, federal approval trumps a state restriction. Mississippi's law is "an impermissile effort by Mississippi to establish its own drug approval policy and directly regulate the availability of drugs within the state," says GenBioPro's lawsuit.
GenBioProg's argument is a little shaky, say some legal experts. Congress has never explicitly said that FDA drug approval preempts state laws (as it has with medical devices). And "the court has generally moved in an anti-preemption trend and has been skeptical of arguments that a state law generally impedes the interests of the federal government," lawyer Ilana Eisenstein told Reuters recently.
But "similar challenges have succeeded before," notes Reuters. "In 2014, a Massachusetts federal judge struck down a state law seeking to regulate opioid drugs more stringently than federal law on the grounds that it was preempted."
And state laws totally banning an FDA-approved drug may be different than state rules simply regulating how it is prescribed. "The courts have generally found that the states have regulatory authority over the practice of medicine," Wendy Parmet, director of Northeastern University's Center for Health Policy and Law, told Bloomberg Law. But saying "'You can only prescribe it from an in-person visit in the first six weeks of pregnancy,' becomes a very different case than just saying, 'You can't sell a drug that's on the interstate market,'" she points out.
How governments will handle abortion pills crossing state lines will be one of many battles in the upcoming "interjurisdictional abortion wars," suggest David S. Cohen, Greer Donley, and Rachel Rebouché in a forthcoming article in the Columbia Law Review.
They note that in a post-Roe world, the FDA could work with the Department of Justice to sue states over mifepristone bans. This seems to be what Garland was hinting at in his statement. But how such suits would play out is unclear from current case law.
No matter what happens, abortion pills may still be fairly easy for women in these states to get prescribed remotely, as Reason's Jacob Sullum noted last December. "If you think states can actually prevent medical abortions, you must be unfamiliar with the war on drugs, which has failed for more than a century to stop Americans from obtaining politically disfavored intoxicants, even when they are illegal in every state," Sullum writes.
And even if American doctors won't prescribe to people in states where abortion is banned, some international doctors and pharmacies will.
