The Biden administration could more vigorously defend its authority over medication abortion as it fights a wave of state restrictions, legal observers say.
Sunday marked the 50th anniversary of Roe v. Wade, which until last year’s Dobbs ruling guaranteed a federal right to an abortion. President
That drug, when coupled with misoprostol, is approved by the Food and Drug Administration to end a pregnancy within the first 10 weeks.
Biden’s memo puts the full force of the White House behind defending mifepristone access. But the patchwork of state abortion laws and ongoing legal disputes remain barriers to access.
“President Biden’s memo is, in effect, drawing a line in the sand, saying that his administration will do everything legally possible to protect access to medication abortions, including in red states,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “This is setting the administration up for a long and fierce legal battle with states.”
Health experts want to see the Biden administration more clearly argue that the FDA’s regulations trump state laws. They also note that guidance as called for in the Biden memo could put pharmacies more at ease about distributing abortion medications.
“The administration can take a stand on preemption,” said Rachel Rebouché, dean of Temple University’s Beasley School of Law.
‘Pills in the Hands of People’
The Biden administration’s memo calls on the HHS to put forth guidance for patients trying to legally access the abortion pill mifepristone as well as for pharmacies and other entities looking to “legally prescribe and provide mifepristone,” an abortion medication currently under attack in numerous states.
Such guidance “would probably need to be state specific,” and would likely mean an attempt to clarify what federal rules apply, Rebouché said.
The idea of the memo, she said, “is to clarify when abortion is permitted and when it is not,” Rebouché said. “It doesn’t necessarily put pills in the hands of people. But it could clarify exceptions under the law and when federal laws” apply.
After the Dobbs ruling in June, Attorney General Merrick Garland said in a statement that states can’t ban mifepristone based on disagreement with the FDA’s judgment of the pill’s safety and efficacy.
But several states still have limits on the medication, including prohibiting distribution via telehealth.
The FDA earlier this month announced that pharmacies could start getting certified to dispense mifepristone under the drug’s updated safety plan. Some states reacted to this news by noting state laws that restrict the dispensing of abortion pills. In Florida, individuals can face criminal penalties for performing or assisting abortions anywhere other than hospitals or physicians’ offices.
Additional HHS guidance “could help a pharmacy feel comfortable dispensing pills for legal uses,” and register with the FDA to provide abortion medications “even if the state is trying to imply that it is illegal to seek certification,” said Greer Donley, a law professor at the University of Pittsburgh.
But from a practical perspective, for pharmacies in states that ban the majority of abortions, “there is no business interest to seek certification,” Donley said. In such locations, “it would be so rare to ever dispense the pills that it wouldn’t be worth the burdens of certification,” she said.
Lingering Litigation
However, Northeastern University Center for Health Policy and Law Director Wendy Parmet said, “Unless and until some courts rule that federal law preempts state bans on using medication abortions to stop pregnancies, providers are apt to remain wary of administering medication abortion.”
In Parmet’s view, the FDA’s call to allow mifepristone to be prescribed via telehealth and dispensed through pharmacies would ease access to the drug in states that don’t ban abortion.
But while that “may inevitably make it easier for some drugs to get across state lines and be used in some instances in which the legality is questionable,” she noted that “providers in states that ban abortion will remain very wary,” and that she doubts “guidance from HHS can truly quell their concerns.”
“That leaves me to think that the administration’s most effective tools are probably legal and political,” she said, considering Biden’s memo as part of that political strategy.
A coalition of anti-abortion organizations led by conservative legal group Alliance Defending Freedom is in court in Texas trying to reverse the FDA’s approval of mifepristone in 2000. The FDA has said the case is without merit and based on “speculative allegations of harm,” but legal observers have said ADF could find a sympathetic ear in the President
GenBioPro, which manufactures the generic version of mifepristone, previously made the federal preemption argument in a lawsuit against Mississippi’s abortion pill restrictions, including a requirement that a licensed physician prescribe the pill in person. The company withdrew its complaint in August, but plans to refile in another state.
“Since states have primary responsibility for regulating abortions, along with the practice of medicine and pharmacies, the administration may have an uphill battle in the courts,” Gostin said. “The Supreme Court in particular is strongly supportive of federalism and states’ rights, making it uncertain if the Biden administration will prevail over the long term.”
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