Archive for the Abortion Pill Horrors Category

Group vows to defy FDA, continues dispensing abortion pills illegally

Posted in Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, Abortion Pills Illegal, DANCO, FDA, Illegal abortion, Population Control with tags , , , , , , , , on June 1, 2019 by saynsumthn

abortion pill

Just days after 100 lawmakers sent a letter to the Food and Drug Administration (FDA) — which oversees drug safety — requesting that the FDA monitor abortion group Aid Access for illegally dispensing abortion pills, Aid Access announced its intent to defy the FDA’s warnings to “immediately cease” dispension of the drugs.

Aid Access founder Rebecca Gomperts published her response on Aid Access’s website as well as on Women on Waves, another organization Gomperts founded in 1999. Gomperts claims, “Last year, I prescribed 2,581 medical abortions out of 11,108 women who consulted me.”

Gomperts states in part:

On March 8, 2019, I received a letter from the FDA ordering my new (since 2018) organization, Aid Access, to stop providing telemedical abortion services to women who cannot otherwise access safe abortions because of costs, domestic violence, distance, or other reasons, and who do not have access to other doctors willing or able to prescribe misoprostol and mifepristone.

This letter was applauded by Republican members of Congress, of whom 92 percent are male.

But I will not be deterred. When U.S. women seeking to terminate their pregnancies prior to 9 weeks consult me, I will not turn them away. I will continue to protect the human and constitutional right of my patients to access safe abortion services.

Notably, the Congressional letter was signed by a number of women in Congress, including Reps. Martha Roby, Carol D. Miller, Virginia Foxx, Liz Cheney, Ann Wagner, Jenniffer González Colón, Debbie Lesko, and several medical doctors who also serve in the House of Representatives, among many others.

Rebecca Gomperts founder of Aid Access defiant to offer illegal abortion pills online

In a statement to Live Action News, the FDA wrote:

As noted in the FDA warning letter to AidAccess issued on March 8, 2019, failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice. We cannot comment on a potential future action at this time, but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health. Unapproved drugs purchased from foreign internet sources are not the FDA-approved versions of the drugs, and therefore, they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.

The statement went on to say that “The FDA’s regulation and oversight of the drug approval process and drug distribution helps to protect patients by applying rigorous scientific and safety standards, requiring labeling review for accuracy and completeness, and working to ensure that counterfeit and unsafe medicines do not enter the U.S. drug supply. When these requirements are not met, FDA can step in to help protect consumers.” The FDA reiterated that it has warned AidAccess.org and Rablon that they are in violation of the Federal Food, Drug, and Cosmetic Act for causing the introduction of unapproved new drugs into U.S. commerce.

Drugs are tightly regulated by the FDA for a reason, and under current requirements, the abortion pill — also known as Mifeprex or Mifepristone — is only permitted to be dispensed in hospitals or clinics by medical personal who are approved prescribers of the pill. FDA placed Mifeprex under a tighter regulatory system known by the acronym REMS (Risk Evaluation and Mitigation Strategy), “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:

  • [O]nly be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications.
  • [T]he products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.
  • They are not available in retail pharmacies and are not legally available over the Internet.

The FDA has warned women against purchasing these dangerous pills online: “Do Not Buy Mifeprex Over the Internet.

FDA warns consumers to not buy abortion pills over the internet

The FDA adds, “You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others). Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.”

READ: AWFUL: Abortion groups tell women to lie about abortion pill, claim miscarriage

Weeks ago, the FDA updated its adverse events report through 2018, documenting “24 deaths of women associated with Mifeprex since the product was approved in September 2000….” The FDA also noted at least 4,200 additional adverse effects. Under 2016 changes, the drug’s manufacturer, Dancono longer has to report non-fatal adverse effects, so we can only imagine what the number really is.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

Live Action News previously documented a larger push by pro-abortion organizations to lift the FDA’s REMS requirements, to expand abortion pill dispension to mail order and online sales, via self-managed abortions. And we also documented the secretive history of Danco’s investors, which include organizations such as the Packard Foundation and other abortion philanthropists, who appear to stand to gain financially from a broad abortion pill expansion. The original drug, Mifeprex, was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council.

The defiance by Aid Access comes on the heels of multiple pro-life bills being passed in several states. Pro-abortion organizations, who used to claim that self-abortions injure and even kill women, now appear willing to place them in harm’s way. In addition, when these same women experience serious complications from these dangerous pills, they are instructed to present to the ER and lie, claiming they had a miscarriage. Ironically, while the abortion lobby shows support to Aid Access, they simultaneously want to discredit the science behind abortion pill reversal.

Editor’s Note 5/17/19: This article was edited to include a statement from the FDA.

  • This article is reprinted with permission. The original appeared here at Live Action News.

FDA: 24 women die from abortion pill, thousands of serious complications

Posted in AAPLOG, Abortion death, Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, DANCO, Daniel Grossman, Generic Abortion Pill, Inc., Packard Foundation with tags , , , , , , , , , , , , , , , , , , , , , , , , on April 23, 2019 by saynsumthn

As more women die from abortion pill, the FDA approves a generic version

abortion pill, emergency contraception

 

The FDA has approved a generic version of the abortion pill Mifeprex, at a time when more deaths are being reported and the abortion industry is pushing for the dangerous abortion inducing chemicals to be dispensed online or by mail. According to a notice from the FDA, the generic version is approved for use as an abortifacient. This news comes just a day before the FDA updated its adverse effects reports through 2018, stating, “As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal…” The FDA’s 2017 report put the number of deaths at 22.

This means that in 2018 alone, two more women died from taking the abortion pill. And yet, now a generic version is going to be made available.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

To date, the report documents nearly 4,200 reported adverse effects, including hospitalization and other serious complications.

On April 11, 2019, the FDA approved GenBioPro, Inc.’s abbreviated new drug application for a generic Mifeprex, which, when used with Misoprostol is approved as an abortion pill regimen. The FDA states (emphasis added), “This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation….”

READ: The secrecy surrounding the abortion pill’s maker and influential financial investors must end

Generic abortion pill by GenBioPro approved by FDA

The FDA also states clearly that although they modified the Mifeprex application to include “mifepristone products,” this change in no way removes the FDA’s REMS (Risk Evaluation and Mitigation Strategy), “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.

Find approval information for this 2019 supplement here.

The approved generic version of Mifeprex generally has the same labeling as Mifeprex…Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.

Requiring that the generic be subject to FDA’s REMS is good news for now, because, as Live Action News has previously reported, the abortion lobby is attempting to expand access to the abortion pills via mail order or pharmacy by pushing “self-managed abortion,” described by Guttmacher as ending a pregnancy “without direct supervision by a health care provider.” To accomplish this, REMS, must be eliminated.

READ: What you should know about the dangerous ‘self-managed’ abortion pill push

Dr. Donna Harrison, Executive Director American Association of Pro-Life Obstetricians and Gynecologists(AAPLOG), agreed, telling Live Action News (emphasis added):

Allowing a generic equivalent of Mifeprex basically means that the patent restrictions have run out. So, new drugs have a patent which is time limited… and in the case of Mifeprex, the patent was held by the Population Council. So, now that the patent has run out, generics are allowed. But this does not change the restrictions. REMS are still in place until FDA changes the restrictions. So, just to clarify, this does not mean that Mifeprex is OTC [over-the-counter]. It just changes how much quality control goes in to the pill manufacturing process and how much Danco can charge for the drug.

The move towards a generic drug is being hailed a victory by abortion advocates, specifically Dr. Daniel Grossman, who has deep tiesto the “self-managed” abortion pill push.

Image: FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

Image: FDA Approves generic abortion drug NWHC (Image: Twitter)

FDA Approves generic abortion drug NWHC (Image: Twitter)

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:

  • [O]nly be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications.
  • [T]he products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.
  • They are not available in retail pharmacies and are not legally available over the Internet.

The original drug (Mifeprex) was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council, and was seeded by the Packard Foundation among other pro-abortion philanthropy groups. They then set up a highly secretive company named Danco to manufacturer the drug.

The generic version is produced by GenBioPro, Inc., which also appears to have the financial support of abortion collaborators. In fact, Packard gave GenBioPro, Inc. $185,000 in 2016 and 100,000 in 2017. According to the Nevada Secretary of State, a 2007 filing for the company was permanently revoked. A new filing in 2011 is active and shows a registered agent of CSC Services of Nevada, Inc. and the only officer listed is E. Masingill.

The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect patient health.

    • This article is reprinted with permission. The original appeared here at Live Action News.

‘So painful. So much blood’: Women share abortion pill horrors on YouTube

Posted in Abortion pill, Abortion Pill Horrors, Baby saved from abortion with tags , , , , , , on January 15, 2019 by saynsumthn

abortion pill

Despite potential for dangerous outcomes, abortion advocates are pushing “at home” or “mail order” abortions. FDA reports indicate that almost two dozen women who took abortion pills have died as a result, and a thousand have been hospitalized. And now, some women are sharing their testimonies on YouTube, giving a glimpse into their mindset, the physical and emotional results of taking the abortion pill, and the reality of abortion.

One inside view comes from a video entitled, “My Abortion Experience as a Freshman | Abortion Pill.”  In comments to the video, a woman named Brittany claims she obtained abortion pills from Planned Parenthood as a freshman in college.

Brittany described her abortion experience in the video in some disturbing ways, even though she claims she does not regret her abortion:

  • “I did not realize how much pain it was going to be.”
  • “At first it felt like really bad cramps…it just started getting worse and worse….”
  • “The pain of it was just ridiculous – I completely regret not taking the pain meds…. I was in so much pain.”
  • “I couldn’t walk – I couldn’t talk….”

READ: Woman bled 40 days from abortion pill: It was ‘like the scene of a murder’

Image: Brittanys Room abortion story from YouTube as freshman (Image: Screen from YouTube video)

Brittanys Room abortion story from YouTube as freshman (Image: Screen from YouTube video)

While Brittany admitted to emotional and physical struggles when she discovered her pregnancy, she also detailed her emotional state after the abortion:

  • “I was so depressed.”
  • “It was so bad that I wasn’t eating. My nails turned blue…. None of my clothes fit me because I lost so mush weight…. I was failing all my classes…. It was just a really bad time.”
  • “At one point – like – I felt the embryo come out…. I just picked it up and flushed it, I didn’t know what else to do….”

Women on college campus need real solutions and support, not pills they take all alone. And yet, there is a movement to force publicly funded colleges and universities in California to offer the abortion pill on campus to pregnant women. SB320, as the bill was dubbed, was vetoed by the state’s pro-abortion Governor Jerry Brown, but lawmakers are still trying to get it passed.

The abortion pill process is explained by Dr. Anthony Levatino in the video below:

 

READ: Hey, Teen Vogue, these 15 women say taking the abortion pill is nothing like having a period

Another 20-year-old YouTuber, who claims that she was on “birth control” for some time, said that she paid Planned Parenthood $350 for the abortion pill when she became pregnant, but her baby survived. “You get no refund,” if it fails, she emphasized. The three-part series is titled, “My Miracle Baby After Taking Abortion Pill.”

“At this point” of taking the abortion pill, she says, “the baby is seven weeks old.” She reasoned at the time, “It’s probably not a baby yet, it’s just a mass of cells, it’s nothing.” Which, of course, isn’t true:

She begins by emotionally introducing her 5 month old son: “I didn’t know that I wanted him at the time I got pregnant and I made a rash decision to get the abortion pill.” According to her story, after she took the second pill in the abortion pill regimen, she immediately began to bleed:

It was within ten minutes I was bleeding… It was so painful… it was more like contractions… And it was a bloody horror show…. It was so much blood…. I was passing blood clots the size of golf balls that could literally fit in your hand…. It was a lot of blood and a lot of clots and it was very traumatizing. And I was in a lot of pain. And instantly, I regretted my decision. And instantly I felt so guilty….

She adds, “… I bled for 2 weeks after taking the pills. I didn’t go back for the ultrasound because I was sure it had worked….”

Her testimony also states, “I became really really depressed…. It got so bad to the point that I didn’t trust myself being alone…. I didn’t feel safe being by myself because of the guilt I was having…. I just felt so bad….”

She claims that a few months later she discovered she was still pregnant.

Image: Women claims she took abortion pills and baby survived

Women claims she took abortion pills and baby survived (Image: Screen shot from video)

“Moral of the story- it didn’t work, thank God,” she says. “And, he’s here and he’s healthy and he’s happy…. I didn’t think I would be able to care for a baby…. This just goes to show that you can do it, you can be a mom and you can have a baby…. Babies are the greatest thing ever. He has brought me so much happiness, so much love to my life, and I could not picture my life any way without him…. I love him more than life itself. I cannot even imagine if the pill would have worked, and I am so thankful that it didn’t. I am so thankful that I got a second chance at being a mom….”

“Babies… are just pure love,” she adds. “He really did change my life for the better.”

    • This article is reprinted with permission. The original appeared here at Live Action News.