FDA eases regulations on the abortion pill

by christiannewsjournal
Plan B

WASHINGTON — The Food and Drug Administration has updated its guidelines concerning the abortion drug mifepristone, allowing women to take it later in pregnancy and with reduced medical supervision.

The New York Times called the update “an unequivocal victory for abortion rights advocates.”

Previously, women were permitted to take mifepristone (formerly known as RU-486) up to the seventh week of pregnancy, but that has been extended to 10 weeks. Recommended dosage has been lowered from 600 milligrams to 200 milligrams to reflect “standard medical practice,” according to The Times, and the number of visits to a health care provider required in conjunction with the drug’s administration has been reduced from three to two.

  1. Ben Mitchell, an evangelical bioethicist, said in written comments, “The FDA regulates drugs based on safety and effectiveness, not other ethical factors. Unfortunately, mifepristone (RU-486) is not safe for unborn human beings though it is relatively effective in ending their lives.

“One might wish there were a drug that could heal our national conscience, but that can only come about through a spiritual and moral awakening,” said Mitchell, provost and Graves Professor of Moral Philosophy at Union University.

The FDA approved the updated mifepristone guidelines March 29 in response to a request submitted by New York-based Danco Laboratories, the company that markets the drug under the label Mifeprex, according to the FDA website.

At least six states — Ohio, North Dakota, Texas, Arkansas, Oklahoma and Arizona — had passed laws mandating that abortion providers stick to the previous FDA protocol, the Associated Press reported. The Arkansas and Oklahoma laws were stayed pending legal challenges, and a court struck down Arizona’s.

The Times said the new guidelines’ implications for existing state laws were “not immediately clear.”

Ohio’s law restricting “off-label” use of mifepristone corresponded to a decrease in the percentage of abortions performed via drugs rather than surgery from 10-15 percent to less than 2 percent, AP reported.

LifeSiteNews claimed prescribing a lower dose of mifepristone than the previous FDA recommendation saved approximately $200 per abortion for providers, though there is no evidence abortionists passed that savings along to patients.

Mifepristone works by blocking the hormone progesterone, which “is needed for a pregnancy to continue,” according to the FDA. The lack of progesterone “causes the newly implanted child to detach from the mother’s uterine wall,” LifeSiteNews noted. A follow-up drug known as misoprostol, taken 24-48 hours later, works with mifepristone to cause uterine contractions and expel the baby.

The later mifepristone is administered during pregnancy, the greater its likelihood of failure, according to video posted on LifeSiteNews.com featuring obstetrician Anthony Levatino. At nine weeks, one in 10 attempts to induce abortion using mifepristone fails, he said.

With mifepristone-induced abortions, deceased babies “often” are expelled in toilets and flushed, Levatino said.

The FDA website states mifepristone “is only available to be dispensed in certain healthcare settings” and “is not available in retail pharmacies” or “over the Internet.” Authorized dispensers must ensure provision of “any necessary surgical intervention” and access to “medical facilities for emergency care.”

The newly-approved FDA label requires a follow-up visit to a woman’s health care provider 7-14 days following administration of the drug “to be sure you are well” and “the pregnancy has passed from your uterus.” The label continues, “If you are still pregnant, your healthcare provider will talk with you about a surgical procedure to end your pregnancy.”

National Right to Life’s Randall O’Bannon argued in an online commentary that even with the new guidelines’ reduced dosage, chemical abortions remain dangerous for women — not to mention the babies whose lives are taken.

“For women, the mifepristone/misoprostol combination comes with significant cramping, bleeding, and other gastrointestinal side effects (nausea, vomiting, diarrhea) that are expected parts of the chemical abortion process,” wrote O’Bannon, NRL’s director of education and research.

“While it may be claimed that these side effects are supposed to be reduced with the new protocol, chemical abortions simply do not occur without significant bleeding, cramping, etc. That these side effects are similar to signs of ruptured ectopic pregnancy, serious infection, or may be the prelude to significant hemorrhage that could be missed by patients or even doctors expecting these as part of any chemical abortion would still appear to be a problem under any protocol,” O’Bannon wrote.

The FDA label confirms “cramping and bleeding are an expected part of ending a pregnancy.” It adds a warning that more serious side effects may occur, including death, but notes such “problems” can also occur during surgical abortions or childbirth.

O’Bannon concluded, “In the end, it is obvious that the FDA’s new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient.”

— by David Roach | BP

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