FDA Draws Fire Over New Abortion Pill Regimen

The move from the Obama administration comes at a time when the abortion industry is facing pressure from state laws, and sees the market moving toward ‘medication abortions.’

(photo: umadclassifieds.com)

WASHINGTON — Abortion advocates seeking to push abortion out of their facilities and into the four walls of a woman’s home received a boost from the Obama administration last week, when the federal Food and Drug Administration relaxed guidelines for the abortion pill known as mifepristone or RU-486.

The FDA announced March 30 that it was revising its labeling for mifepristone, sold commercially in the U.S. as Mifeprex, after reviewing data and information submitted by the drug manufacturer. Mifeprex is the first drug taken in the two-step RU-486 chemical abortion regimen. After a woman takes Mifeprex (mifepristone) to kill the unborn child in its early development, she takes another pill called misoprostol (commercially known as Cytotec) 24 to 48 hours later to expel the deceased unborn child.

The new FDA labeling aligns closely with the off-label usage (200 mg of Mifeprex administered up to 9 weeks gestation) advocated for years by the Planned Parenthood Federation of America, the largest U.S. abortion provider, and the National Abortion Federation. Abortion proponents had sought the FDA’s approval of the off-label usage to counteract the attempts in a number of states trying to restrict the RU-486 regimen to the FDA labeling set in 2000. Arizona Gov. Doug Ducey, for instance, recently signed into law a bill specifying that abortionists had to comply with FDA regulations as they existed on Dec. 31, 2015.

The 2016 revised FDA labeling for Mifeprex reduces the dosage previously recommended by the FDA in 2000 from 600 mg to 200 mg, and expands the range for administering the drug from the previous limit of seven weeks (or 49 days) gestation up to 10 weeks gestation (or 70 days since the first day of a woman’s last menstrual period). The revised FDA protocol also no longer explicitly states that a certified physician must approve the drug’s use for abortion, and now specifies that a “certified healthcare provider” may prescribe, order, and supervise the use of Mifeprex — abortion proponents had called for nurses and midwives to be able to dispense the abortion drugs, as the industry is experiencing a shortage of doctors willing to perform abortions.

Cardinal Dolan: ‘Irresponsible’

Cardinal Timothy Dolan, archbishop of New York and chairman of the U.S. Conference of Catholic Bishops' Committee on Pro-Life Activities, characterized the FDA’s decision as “paving the way for the destruction of even more innocent lives, and putting women and girls at risk for all the life-changing effects of abortion.”

"The FDA has irresponsibly loosened its guidelines for the dangerous abortion drug RU-486 expanding its use an additional three weeks into pregnancy, and allowing provision by non-physicians," he said in a statement.

The cardinal also said that abortion advocates’ celebration of the FDA decision showed they were committed to “an ever-widening door to abortion” and were far from wanting abortion to be “rare.”

“They are equally celebrating the FDA's neglect of women's health,” he added. “Women have died from this drug, and many who used it after eight weeks of pregnancy ended up returning for surgical abortions. This anguish, too, will now be visited on more women."

Although the FDA labeling is new, the off-label use of Mifeprex for abortion has been routine for years. According to the Guttmacher Institute, an abortion research firm with historical ties to Planned Parenthood, approximately a quarter of the 1.06 million abortions that took place in 2011 were RU-486 “medication abortions.”

In 2011, the FDA reported that 1.52 million women had taken Mifeprex since its approval in 2000. By then, 14 women had died (including eight from sepsis), along with 612 hospitalizations and 256 infections, following use of the drug to cause an abortion.


Pro-life Doctors Prepare

Dr. George Delgado, medical director of the Culture of Life Family Services in San Diego that runs the AbortionPillReversal.com program and its 24/7 hotline, told the Register that it was fairly rare for them to get a client given the previous FDA recommended dosage of Mifeprex, as the 200 mg dosage was usually prescribed because it was cheaper and equally effective in causing an abortion.  

However, he said some abortion providers had pushed beyond the off-label recommended gestation limit of nine weeks. The later Mifeprex is administered, the greater is the risk of further health complications.

“There will be others who push it beyond the 10 weeks of course, and we’ll see more who do it at 12 weeks. That’s what I expect to see,” he said.

Delgado oversees a network of more than 300 physicians involved in reversing the effects of Mifeprex through progesterone treatments for women who change their mind about abortion within a 72-hour period, and have not taken misoprostol. He said up to 95% of clients seeking abortion pill reversal have found them through the Internet, where they can call the hotline number 24/7 to begin the process.

Mifeprex works by blocking the hormone progesterone from bonding to the uterine wall, causing it to shed, killing the embryo. However, Delgado explained the abortion pill reversal protocol involves overwhelming Mifeprex with progesterone to save the uterine lining.

“Fortunately, these hormone receptor blockers are like keys that go in and out of the lock, they just don’t sit there forever,” Delgado said. “When the false key is out of the lock, there is a chance for a true key to get in there, so by giving more progesterone, more of the true keys, we try to outnumber the bad keys. … We get more good guys on the playing field.”

He said the success rate so far has hovered between 55%-60%, which is far above the mifepristone embryo survival rate of 7%-20%. They are preparing a new study of 200 cases involving the protocol, and are looking to determine down the road which delivery method gives women the best chance at saving their pregnancies.


Critical Time for Abortion Industry

The FDA’s revised labeling in 2016 comes at a time when the abortion market is moving the industry toward earlier abortion.

A 2013 paper by Heather Boonstra in the pro-abortion Guttmacher Policy Review noted that nine out of 10 abortions happen in the first 12 weeks of pregnancy — 73% of these abortions happen in the first nine weeks, a range covered by the new FDA guidelines for Mifeprex.

Boonstra stated that “the longer term trend is toward abortion even earlier in pregnancy,” and that “the availability of Mifeprex is credited with accelerating the trend toward very early abortions.”

According to the research Boonstra cited, 60% of women who had an abortion reported wanting to have it earlier, and women seeking telemed abortions (where Mifeprex is prescribed over a video link, not an in-person office visit) reported wanting to have the abortion close to home and early as possible.

However, the trend was threatened, Boonstra wrote, by state laws requiring abortion providers follow the 2000 FDA standards and not the off-label use that had become standard almost immediately throughout the industry after the FDA’s approval of Mifeprex.

Pro-life advocates pointed out that the FDA decision comes at a critical time for the abortion industry, which has faced an unprecedented surge of state-level pro-life legislation since 2011. One of the most significant challenges involves a Texas abortion regulation law before the U.S. Supreme Court that could drive down the number of active abortion centers in the state from 40 to 10.

Its flagship provider, Planned Parenthood, has also been saddled with state and congressional investigations owing to damaging undercover videos alleging the organization was engaged in the criminal harvest and trafficking of fetal tissue from aborted infants.

“Shame on the FDA for caving to the financial interests of abortion businesses like Planned Parenthood, which are looking to expand chemical abortions nationwide as a means of skirting clinic health and safety standards in order to increase profits,” Marjorie Dannenfelser, president of the D.C.-based Susan B. Anthony List, told the Register.

“This irresponsible decision means women in difficult, stressful situations will face even more isolation, loneliness, and health complications,” she said.


Political Decision?

Rep. Chris Smith, R-N.J., the co-chairman of the Bipartisan Congressional Pro-life Caucus, criticized the FDA’s decision in a statement as a political move made “at the behest of the abortion industry” that mirrored in 2016 the FDA’s decision in the waning days of the Clinton Administration to expedite mifepristone’s approval in 2000 before the presidential election.

Smith stated, “Abortion advocates today are celebrating FDA’s expansion of ‘medication abortion,’ but women who have suffered the trauma of a mifepristone abortion know that it is not ‘medication’ — this chemical poison is not designed to heal, or cure, or mitigate pain.”

Peter Jesserer Smith is a Register staff reporter.