The U.S. Food and Drug Administration last week modified its restrictions on mifepristone, one of the medications used in abortion. The new regulations enable abortion via telemedicine in more than half of the country.
“The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project, in a statement.
“Now patients can see a healthcare professional in a telehealth visit and then have the medications mailed to their home,” Moore added.
WHY IT MATTERS
Mifepristone is one of the two drugs used in medication abortion, which has been approved by the FDA through 10 weeks’ gestation.
Since its initial approval, it has been subject to a so-called Risk Evaluation and Mitigation Strategy, which required it to be dispensed at a clinic, hospital or medical office.
During the pandemic, the FDA had temporarily stopped enforcing the in-person dispensing requirements on mifepristone, following a back and forth in the courts about their necessity.
The permanent modification of the requirement means that abortion providers in many states will be able to send medication to patients via mail-order pharmacy, bridging some access gaps in places with few in-person clinics or burdensome multi-appointment waiting period rules.
Still, some researchers and advocates have noted that the FDA left in place some certification components for providers and pharmacies, as well as patient agreements that staff had recommended removing.
They also point out that abortion via telemedicine is illegal in 19 states, and that 32 states require abortion medication to only be administered via physicians (as opposed to nurse practitioners or midwives).
In addition, existing hurdles to virtual care – such as broadband access – may still obstruct access to abortion via telehealth.
“The FDA took an important step toward abortion justice by permanently lifting the in-person dispensing requirement on medication abortion,” said Destiny Lopez, co-president at All* Above All, in a statement. “While the action today will go a long way for people seeking care, other barriers remain and must be lifted once and for all.”
THE LARGER TREND
Abortion providers told Healthcare IT News this past year that they had already shifted much of their practice virtually in the interest of patient safety during the COVID-19 pandemic.
But the change in rules meant that clinicians in eligible states could “operationalize an overnight mailing system” for abortion medications.
Separate from the FDA rules, of course, is the question of broader restrictions on telemedicine, which have also been temporarily relaxed. Reinstated rules could, for example, make insurance coverage for abortion via telemedicine, which is already limited, less available.
Although Congress has put forth several bills to safeguard telemedicine access past the end of the public health emergency, none have made their way into permanent law.
ON THE RECORD
“The FDA must permanently lift all restrictions on medication abortion and states with politically motivated bans on medication abortion, particularly via telehealth, must reverse these policies so people can get care in a way that makes sense for them,” said Lopez.
Kat Jercich is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a HIMSS Media publication.
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