Dr. Thomas Price, Secretary of the Department of Health and Human Services, please take note. Your U.S. Food and Drug Administration (FDA) will soon be cooperating (conspiring) with abortion activists to relax important health regulations so that America’s only approved abortion regimen can be sold by local drug stores. In fact, the process may well be underway as I write.
Big Abortion’s aggressive push for evermore abortion, despite great health concerns for the mother (not to mention the baby), appears to know few bounds. Mifepristone, also known as RU-486, is incontrovertibly an embryo and fetal-destructive chemical. Mifepristone (also, Mifeprex®) blocks the chemical action of progesterone, the key hormone that drives pregnancy forward. Mifepristone is taken with a second drug, misoprostol (Cytotec), which causes uterine-emptying contractions when taken by a pregnant woman. This two-drug abortion regimen was first approved by the FDA in 2000.
There are many details related to the distribution of this regimen, but the key points to note are that access to the mifepristone itself is still pretty tightly controlled. The current 2016 regulations for the mifepristone regimen do not allow it to be sold in pharmacies. Rather, mifepristone may be distributed only by certified healthcare providers (originally, it had to be a physician). Such providers must have the ability to assess the duration of the pregnancy accurately, be able to diagnose ectopic pregnancies, be able to get the patient to surgical intervention in case of an incomplete abortion or severe bleeding, and, finally, must have read the prescribing information about the regimen. Clearly this sort of patient assessment cannot take place at pharmacies. The regimen may not be prescribed after the 70th day of pregnancy (LMP).
On February 23rd, a group of ten abortion activists calling themselves the “Mifeprex REMS Study Group,” most of whom are physicians, argued that the Mifeprex regulatory scheme is obsolete and that the regimen should be sold in pharmacies. This piece of abortion advocacy appeared in the New England Journal of Medicine.
“REMS” is an FDA acronym that stands for “Risk Evaluation and Mitigation Strategy.” The REMS for the Mifeprex regimen—the use requirements put in place to mitigate dangers to patients from a drug’s use—were already weakened by the Obama administration less than a year ago as it was going out the door. It was at that time that the FDA allowed for the amount of mifepristone in the regimen to be cut by two-thirds, and for the regimen’s use to be extended from 56 to 70 days when the failure rate at the earlier marker was already significant. Furthermore, a second office visit was also eliminated from the requirements—which was simply shocking given the complications that can occur, including incomplete abortion and ongoing pregnancy.
My colleague Arina Grossu and I also called on the FDA to release the study citations and data that was used to justify the 2016 changes. (See pp. 2-3 of “The FDA Adopts the Abortion Industry Standards for the Mifeprex® (RU-486) Abortion Regimen.”) To the best of our knowledge, the FDA still has not produced a list of citations for twenty-two studies used to justify the relaxation of the regimen’s requirements less than one year ago.
As our paper indicated, serious health complications from the Mifeprex regimen can arise. We know that from May 2000-2011, there have been 14 deaths, 612 hospitalizations, 58 ectopic pregnancies (suggesting inadequate screening), 339 cases of blood loss requiring transfusions, and 256 cases of infection (48 of which were considered severe).
Dr. Price’s team at HHS and FDA needs to stop any effort that Big Abortion is attempting to slip through the agency before the Trump team is in place. Major articles like this one in the NEJM do not appear by accident, so the chances are that an application to effect this change has already been filed or is about to be filed.
Furthermore, an independent medical and statistical review of the 2016 label change needs to be conducted for the purposes of determining whether that previous set of changes was politically and not scientifically motivated. As a gesture of good faith and transparency, FDA should release the most recent summary of Mifeprex regimen adverse events that it produces internally every quarter, so we can see the trend lines since the last data became available to the public.