The Food and Drug Administration expanded its recommended usage of the abortion drug RU-486 in 2016, but the move did not go far enough for some abortion activists.
The Associated Press reports a group of pro-abortion doctors, professors and abortion advocacy groups urged the FDA this week to allow the abortion drug to be made available by prescription at pharmacies across the U.S.
The abortion drug, known by the names RU-486, Mifeprex and mifepristone, is responsible for the deaths of dozens of women worldwide, including several in the United States alone, and it has injured at least 1,100 women in the United States, as of 2006 figures from the FDA. But that didn’t stop the Obama administration from allowing Planned Parenthood and other abortion businesses to expand usage of the drug last year to include uses that the FDA once condemned.
In an article published this week in the New England Journal of Medicine, 10 doctors, academics and abortion advocacy groups argued that the FDA should expand the availability of the drug even more. They said making it available by prescription at pharmacies would increase access to abortion for rural women.
According to the report:
The restrictions have been in place since the drug, mifepristone, was approved for use in the US in 2000. They stipulate that the drug, marketed as Mifeprex, may not be sold in pharmacies and that all providers of the drug undergo a special certification process.
“The restrictions on mifepristone are a shameful example of overregulation run amok,” said one of the authors, Dr. Beverly Winikoff of the New York-based research organization Gynuity Health Projects. “Women and their health providers shouldn’t have to jump through hoops to get a medication that’s been safely and effectively used in this country for a decade and a half.”
According to the commentary, 19 deaths have been reported to the FDA among the more than 3 million women who’ve used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.
Asked about the commentary, the FDA’s media office referred a reporter to a 2016 document asserting that the restrictions on Mifeprex remain necessary for safety reasons. The office declined further comment.
Dr. Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, told the AP this move would be extremely dangerous for women.
“It is a dangerous fantasy to think that unsupervised use of Mifeprex could be construed as anything but harmful to the health and safety of women due to increasing complications, hemorrhages, infections, and failures that occur as the pregnancy progresses,” Harrison said.
The dangerous abortion drug has claimed the lives of more than two million unborn children in the United States since its approval at the end of the Clinton administration. In addition to the number of dead unborn children, women have suffered as well, as a Planned Parenthood study admits at least one woman is seriously injured from the abortion pill daily.
Because of the high failure rate and the risks involved with RU-486 in later pregnancies, the FDA initially limited approval to the first 49 days from the start of a woman’s last menstrual period. Planned Parenthood, by its own admission, ignored this limitation.
Despite that, the Obama administration gave into Planned Parenthood’s demands in 2016 and altered the approved use of the abortion drug to come in line with off-label protocols used by Planned Parenthood and other abortion businesses. The FDA announced that it extended the allowed time period for use of the abortion drug to 70 days.
But, according to the clinical trial submitted to the FDA for approval, the RU-486 regimen fails in 1 out of 12 women with pregnancies less than or equal to 49 days. Those failures, however, increase to 1 out of every 6 women with pregnancies just one week advanced (50-56 days), and further still to nearly 1 out of every 4 pregnancies at 57-63 days gestational age. When using RU-486, 1 out of 100 women with pregnancies less than or equal to 49 days will require emergency surgery, according to the trial; however, this number increases dramatically to 1 out of every 11 women with pregnancies of 57-63 days gestational age.
According to a study on the abortion drug’s safety and effectiveness published in Obstetrics & Gynecology, researcher Chris Gacek noted the abortion drug is more dangerous for women than surgical abortions:
“Overall, medical abortion had roughly four times the rate of adverse events than surgical abortion did: 20.0% of women in the medical-abortion group and 5.6% of women in the surgical-abortion group had at least one type of adverse event. Hemorrhage, as an adverse event, was experienced by 15.6% of medical abortion patients compared with 2.1% for surgical patients. Incomplete abortions were experienced by 6.7% of medical abortion patients while only 1.6% of surgical patients had incomplete abortions. The rate for surgical (re)evacuation of the uterus was 5.9% (medical) versus 1.8% (surgical) for all causes (hemorrhage, infection, incomplete abortion).
A 2006 review of Adverse Event Reports (AERs) related to the use of the RU-486 drug regimen, conducted by Dr. Margaret M. Gary, M.D. and Dr. Donna J. Harrison, M.D. found, “AERs relied upon by the FDA to monitor mifepristone’s postmarketing safety are grossly deficient due to extremely poor quality.”[iv] Drs. Gary and Harrison noted that the deficiency in the AER reports was widespread and consequential,
[A] majority of the AERs analyzed do not provide enough information to accurately code the severity of the adverse event in question. The deficiencies were so egregious in some instances as to preclude analysis.[v]