The FDA released a new approved utilization regime for Mifepristone, a medication used to induce first trimester abortions:
Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). The approved Mifeprex dosing regimen is:
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On Day One: 200 mg of Mifeprex taken by mouth
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24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
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About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider
From Medscape, a description of the previous FDA regime:
Numerous protocols have been studied and are in use, but only 1 has been approved by the FDA.( Table 3 and Table 4 ). The FDA-approved regimen can be initiated up to 49 days after the first day of the LMP and consists of mifepristone 600 mg orally on day 1, misoprostol 400 mcg orally provided at the doctor’s office on day 3, and a follow-up appointment on days 12-20. This protocol is 92% effective in inducing a complete abortion.[12,13] It is hoped that studies using different variations of the FDA-approved regimen will lead to expanded options that are safe and reduced costs.
There are a couple of major changes here. The first is the dose for Mifeprex went down and the second round medication dosagage went up. That may or may not be clinically important. From a policy perspective there are three major changes.
The first is that the FDA allowed window to have a medical abortion goes from 7 weeks after the last day of the woman’s menstrual cycle to 10 weeks. This gives women a lot more flexibility and decision time from the point where she knows she is pregnant to the point where the least invasive option can is no longer FDA approved.
Secondly, the window for the follow-up dosage expands; again this is flexibility which means compliance and follow-up is easier.
More importantly, the change in location for where that second dose is administered is critical. Previously, that second dose was to be down at the doctor’s office. Now it is as a location appropriate for the patient. That is massively more flexible as it means an individual could take the second pill home with her.
Why is this important? It is a counter-move to the proliferation of TRAP anti-abortion access laws as Think Progress explains:
anti-abortion lawmakers — who have mounted an incremental strategy based on chipping away at abortion from all angles — were quick to exploit the discrepancybetween the official FDA label and the real-world medical practice. States started passing laws requiring doctors to stick to the outdated FDA method of prescribing the abortion pill. It was easy for politicians to misleadingly argue that they were simply interested in keeping women safe and ensuring that abortion patients aren’t taking dangerous, unregulated drugs.
This reduces practical restrictions on pharmaceutical abortion access by reducing the number of trips needed while also expanding the time option space. As a side note, it allows clinics a little more flexibility to cope with other TRAP laws as some of the current surgical abortions in restrictionist states can be transferred to pharmaceutical abortions which will free up staff and appointment slots to handle more misogynistic bullshit.
So staffing the federal bureaucracy matters.
Let’s keep that in mind for November!
Doesn’t matter who staffs the bureaucracy: Safe access to abortion editionPost + Comments (30)