The federal appeals court ruling Wednesday night that is keeping medication abortion drugs available is likely to complicate abortion access across the country, even in places where the procedure is legal.
Since the Supreme Court overturned of Roe v. Wade last year, abortion pills – and the US Food and Drug Administration’s rules that allowed patients to obtain them without an in-person visit to an abortion provider – have become a crucial tool for mitigating some of the burdens abortion clinics have felt after the Roe reversal sent them a flood of patients from states where abortion is now illegal.
Since the FDA approved mifepristone in 2000, it has tweaked the rules around how the pills are administered – in keeping with updated knowledge around the science and evidence around the drug. The appeals court is now ordering a return to the stricter, pre-2016 FDA regime around the drug.
Only in very recent years have patients been able to obtain the pills without picking them up from a provider in person.
The requirement was first paused during the Covid-19 pandemic amid litigation during the end of the Trump administration – though the Supreme Court let the restriction go back into effect just before former President Donald Trump left office. The Biden administration then took its own steps to halt and later formally remove the in-person pick up requirement.
The access abortion seekers have had to medication abortion via telehealth – i.e. with virtual visits with their providers rather than traveling to a clinic or hospital in person to obtain the drug – came as telehealth became a more popular option for medical care generally during the pandemic. The ability to dispense the pills by mail has also relieved the pressure on brick-and-mortar clinics in Democratic-leaning states that have become overwhelmed with patients from Republican-led states where the procedure is banned or severely restricted.
According to one newly published study, 9% of all abortions obtained between July and December 2022 were telehealth abortions, the study’s author, University of California-San Francisco Professor Ushma Upadhyay, told CNN.
The ruling might also have an effect on the number of providers who are able to prescribe mifepristone. Because of the administrative and bureaucratic hassles of stocking mifepristone at hospitals and other facilities, some doctors were unable to dispense mifepristone when the in-person pickup requirement was previously in effect, according to court filings submitted in a separate case concerning the mandate. Removing the requirement is believed to have expanded the number of providers able to prescribe abortion pills.
The appeals court is also keeping in place parts of the judge’s ruling that will reverse the 2016 changes the FDA made to its instructions for prescribing mifepristone.
Those instructions include how late into the pregnancy mifepristone should be prescribed (from seven weeks to 10 weeks), the dosage amount and whether the patient must be physically with their provider when the drug is administered.
That aspect of the appeals court order is likely to have less of an effect on the drug’s use than the revival of the in-person dispensing requirement, which is a mandate related to a specific program – known as the Risk Evaluation and Mitigation Strategy – used to regulate mifepristone.
The 2016 changes were to mifepristone’s label. Providers typically have discretion to deviate from a drug’s label. For instance, mifepristone is commonly prescribed to manage miscarriages, but that is an off-label use of the drug.
However, a handful of states have laws forcing providers to prescribe the drug as stipulated on the FDA’s label.
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