Obama’s FDA approves expanded use of RU-486

[Fox News files this under “Women’s Health”!]

FDA authorizes expanded use of medical abortion pill

www.foxnews.com/health/2016/03/30/fda-authorizes-expanded-use-medical-abortion-pill-mifeprex.html

The U.S. Food and Drug Administration has kicked up a potential abortion hornet’s nest with states that impose restrictions on a common abortion-inducing drug, approving a new label for the medication that relaxes guidelines for using it.

The FDA notified the manufacturer of Mifeprex, a drug previously known as RU-486, in a letter on Tuesday that the drug is safe and effective for terminating a pregnancy in accordance with the new label. Also known as mifepristone, the synthetic steroid drug is used in combination with another drug, misoprostol, to end a pregnancy.

Under the new label, a smaller dose of Mifeprex can be used significantly later in the pregnancy — up to 70 days of gestation, from 49 days.

… The National Right to Life Committee argued that the FDA changes would not increase safety for women.

“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,” Randall K. O’Bannon, National Right to Life director of education and research, said in a statement. “It is clear whose interests it is the FDA is serving. It isn’t the women, and it isn’t the babies.”

The new label rules will make it easier to use the drug. Not only do they widen the window for using it, but according to the New York Times, they reduce the number of trips women have to make to a doctor from three to two in most states.

Under the new label, the drug dosage has been reduced from 600 milligrams to 200 as well. According to The New York Times, the previous dosage had been deemed too high by most medical societies and abortion rights advocates said it increased the cost and side effects of the procedure.

[more at the link]

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3 comments on “Obama’s FDA approves expanded use of RU-486

  1. [A political rather than a medical decision]

    FDA changes RU-486 protocol to fit abortion industry’s illegal practices

    Ben Johnson

    WASHINGTON, D.C., March 30, 2016 ( LifeSiteNews.com/news/fda-changes-ru-486-protocol-to-fit-abortion-industrys-illegal-practices ) – The Obama administration has changed the rules for administering a chemical abortion medication to endorse abortionists’ longstanding practice of ignoring previous federal guidelines.

    Today, the Food and Drug Association (FDA) changed the regimen for mifepristone (Mifeprex), significantly reducing the obstacles, burden, and cost to abortionists.

    The FDA approved RU-486 in 2000 after enacting “accelerated approval regulations,” usually used to speed up the introduction of a drug curing a major disease.

    Its guidelines required doctors to administer 600 mg of mifepristone, which causes the newly implanted child to detach from the mother’s uterine wall. The mother then takes 400 mcg of misoprostol, which causes contractions that expel the baby from her womb.

    But abortionists found that prescribing a lower dose of the expensive mifepristone and increasing misoprostol saved approximately $200 per abortion.

    There is no evidence the price they charged for chemical abortions fell in tandem.

    Yet the less expensive protocol became ubiquitous. The National Abortion Federation stated that, by 2008, only four percent of abortion facilities followed the FDA’s guidelines for medication abortion.

    That caused the number of chemical abortions to surge from six percent in 2001 to nearly one-quarter of all abortions, according to the Guttmacher Institute.

    But the new regimen carried a price. National Right to Life’s Director of Education and Research Randall K. O’Bannon, Ph.D., said today’s decision came “despite a record of at least 14 known deaths, and thousands of women suffering.”

    By 2011, there had been 2,207 cases of severe “adverse events,” including hemorrhaging, blood loss requiring transfusions, serious infection, and deaths.

    That led six states – Arizona, Arkansas, North Dakota, Ohio, Oklahoma, and Texas – to pass laws requiring abortionists to adhere to FDA guidelines. But the Supreme Court refused to take up a challenge to a Ninth Circuit Court of Appeals striking down such a law in 2014.

    That cut into profits. Ushma Upadhyay, a researcher for the UC-San Francisco, found that facilities that returned to using the FDA’s previous guidelines saw their number of chemical abortions drop 75 percent.

    Today’s announcement approves mifepristone use 10 weeks into pregnancy. The previous protocol limited the use to the first seven weeks.

    A 1998 study found that nine percent of women who have medical abortions at 57-63 days gestational age will require emergency surgery.

    The new guidelines also allow personnel other than doctors to administer the pill.

    “Extending the upper recommended gestational limit from 49 to 70 days only ensures that the risk of incomplete abortion will be multiplied, as will the number of women visiting emergency rooms around the country suffering from partial or failed abortions,” said Troy Newman, president of Operation Rescue.

    “Certainly, none of the modifications is of any benefit to the unborn child,” O’Bannon added.

    “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.”

    Abortionists were overjoyed. “Today’s FDA announcement of a label change to mifepristone is a significant advancement for women in the United States,” said Amy Hagstrom Miller, the president of Whole Woman’s Health abortion clinics. “All of us are thrilled.”

    A statement from the National Abortion Federation (NAF) said, “We are delighted that the FDA has approved a label change.”

    Planned Parenthood said the update would help combat “restrictions on medication abortion enacted at the state level in recent years.”

    “Updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care,” said Raegan McDonald-Mosley, PPFA’s chief medical officer.

    Pro-life leaders emphasized the fact that the new process poses familiar problems.

    “The new label affirms the deadly realities of Chemical Abortion and underscores the need for in-person patient examination and follow-up care, as well as the fact that the abortion drug regimen presents serious risks to women’s health,” said Anna Paprocki, staff attorney for Americans United for Life. “While the abortion industry will falsely celebrate the label change as a green light to its practice of skirting regulations, it would be wise to remember that women and girls have been injured and killed (for example, Holly Patterson) by the abortion industry’s flagrant disregard for the previous FDA label.”

    The FDA’s new label says, “WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING.” (Emphasis in original.)

    Nevertheless, Amy Hagstrom Miller, the president of Whole Woman’s Health abortion facilities, called the FDA decision “ a significant advancement for women in the United States.”

    Newman said that this decision, combined with the abortion industry’s opposition to other state health and safety regulations, leave women more vulnerable than ever.

    “Planned Parenthood of Kansas and Mid-Missouri expanded sales of the abortion pill regimen to their Wichita office earlier this month, which is ill-equipped to treat incomplete abortions or other complications. Licensed physicians who will dispense the abortion drugs hold no local hospital privileges, leaving women to fend for themselves when expected complications arise,” he said.

    “The FDA should be more about protecting the public from exploitative and predatory uses of drugs rather than pandering to Planned Parenthood and the rest of the Abortion Cartel.”

    • President Obama Gives Planned Parenthood a Huge Parting Gift to Sell More Abortions

      JEFF SAGNIP MAR 30, 2016 | www.lifenews.com/2016/03/30/president-obama-gives-planned-parenthood-a-huge-parting-gift-to-sell-more-abortions/

      The abortion president, Barack Obama, has made use of his last months in office to give yet another gift to the abortion industry, a leading pro-life Congressman said today.

      “Today, Obama’s Food and Drug Administration (FDA) changed the label of the abortion pill (mifepristone) to enable the expanded use of this baby-killing drug,” said U.S. Rep. Chris Smith (NJ-04), Co-Chair of the Bipartisan Congressional Pro-life Caucus. “At the behest of the abortion industry, the Obama Administration has extended the use of the drug to 10 weeks of pregnancy. Additionally the new label eliminates the follow-up visit to the physician prior to taking the second part of the drug protocol, and expands who may administer this dangerous drug.”

      Smith said, “Not only is mifepristone used to kill babies, it is a poison that has harmed and even killed women. Yet even with this record, in the last months of his term, President Obama has bowed to pressure from his abortion cronies and has further expanded the use of the abortion pill, putting the health and lives of even more women and children at risk.

      “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,” said Smith.

      Smith pointed to the controversial origins of the original approval of mifepristone in the United States. At the beginning of the Clinton administration, Clinton issued an Executive Order instructing the FDA to re-evaluate the status of RU-486. FDA Commissioner Kessler even urged the European patent-holder, Roussel Uclaf, to submit an application for approval of what was then called RU-486. When mainstream drug manufacturers refused to bring this baby-killing drug to the United States, Population Council licensed the drug and abortion proponents created DANCO for one purpose and one purpose only, to distribute mifepristone in the United States. Headquartered in the Cayman Islands, DANCO had the abortion drug manufactured in China and packaged in New Jersey.

      After a campaign that began at the start of the Clinton Administration, Smith recalled that the abortion pill was first pushed through the FDA approval process under intense political pressure during the final days of the Administration, in a desperate attempt to get the drug approved before the 2000 elections. The drug was given a pass and expedited for political gain at the expense of women’s health and lives.

      See also LifeNews’ STEVEN ERTELT’s Planned Parenthood Killed Women By Misusing the Abortion Pill, Now FDA Says That’s Okay

  2. [Longer use and less physician monitoring will likely cause more suffering. Also, will longer, low-dose use result in more born-alive babies with “malformations”? More below …]

    Feminist Researcher: RU 486 Abortion Drug is Dangerous for Women
    Randy O’Bannon, Ph.D. Nov 24, 2013
    www.lifenews.com/2013/11/24/feminist-researcher-ru-486-abortion-drug-is-dangerous-for-women/

    It caused a bit of a stir in 1991 when three “pro-choice” feminists came out with a book warning of the dangers of the chemical abortifacient RU-486. “RU486: Misconception, Myths and Morals,” written by Renate Klein, a biologist and social scientist from Deakin University in Melbourne, Australia, Janice Raymond, a professor of women’s studies from the University of Amherst (Massachusetts), and Lynette Dumble, a member of the University of Melbourne’s Department of Surgery, won awards and received some momentary coverage in the press. But ultimately, the pro-abortion establishment pushed back and plowed ahead, ignoring the warnings.

    Approved in the U.S., the chemical abortion method is now legally on the market in at least 50 countries. The U.S. Food and Drug Administration (FDA), which approved RU-486 in September of 2000, says that 1.5 million women had used the drug as of April 2011. In Europe, one international group promoting chemical abortifacients says that as of 2009, RU486 had already been used by two million (womenonweb.org, accessed 11/19/13, at www.womenonweb.org/en/page/561/is-a-medical-abortion-dangerous ).

    The notorious chemical abortion method is, of course, actually a two-drug combination. RU-486 (known as mifepristone) blocks the hormone that creates and sustains the safe, nurturing environment in the womb where the young baby grows. Misoprostol, the prostaglandin given a day or so later, initiates powerful uterine contractions to dislodge the now starved child.

    Over the past several years, there have been modifications of dosages, the addition of antibiotics to some regimens, new warnings have been added to the label.

    Does any of this satisfy Renate Klein, one of the original feminist critics?

    Hardly.

    Writing in a ninety-page preface to a new edition of RU486: Misconceptions, Myths and Morals published earlier this year, far from taking anything back, after seeing twenty plus years of RU-486 on the market, Klein is as convinced as ever that “a down-to-earth rational best practice approach that truly respects women’s health and well being could not, in good faith, endorse this fraught abortion method.”

    Klein repeats here what she has published elsewhere–that she sees a ”RU 486/PG abortion as an unsafe, second-rate abortion method with significant problems”

    Unapologetically “pro-choice,” Klein explicitly favors surgical abortion as a safer, easier option. But her honest, clear eyed appraisal of chemical methods and the significant risks they pose for women is rare among those who champion abortion as essential to women’s rights.

    … Sitruk-Ware also notes the higher risk of infection, potentially serious drug interaction issues, special risks for asthma sufferers, and risk of “malformations” to the “fetus” should the pregnancy continue.

    … Klein, of course, simply wants these chemical abortions replaced by surgical ones, which she considers safer, quicker, and less traumatic. But she does not think being a feminist and “pro-choice” requires that a woman endorse, promote, or endure a method that is, in her words, “unpredictable, unsafe, and often cruel.”

    Obviously, those of us in the pro-life movement can’t help but recognize that for the unborn baby, any method of abortion is cruel and “unsafe.” But Klein shows us here how just how far the abortion establishment is willing to go in putting the lives and health of women at risk to promote their agenda.

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