Archive for REMS

Abortion Weaponization Playbook: strategy to enshrine and expand abortion in America

Posted in Abortion Pill Connections, ANSIRH, expand abortion, Guttmacher, Gynuity, Hollywood, Hyde Amendment, Pro-choice Strategy, RHA, Self Managed Abortion, self-managed abortion, Tax Payer Funding of Abortion, Teen Abortion, Teen Pregnancy with tags , , , , , , , , , , , , , , , , , , , , , , , on June 8, 2019 by saynsumthn
When Planned Parenthood and the media claim “abortion laws” are part of a long held strategy to dismantle Roe and ban abortion- as demonstrated in these Tweets….remind them that it is the abortion lobby that has had a long held strategy to weaponize abortion, as I will demonstrate below.

REMIND them that the abortion lobby and Planned Parenthood want to WEAPONIZE abortion and there has been a strategy to expand abortion: 

#1) Click to READ: EXPOSED: Abortion groups’ plan to ‘increase supply and demand’ for abortion   

A 92-page report on the Tara Health Foundation website should be reviewed by pro-life advocates across the nation, as it details upcoming strategy from abortion supporters, which includes the push for “home use” abortions. The document, as detailed at Live Action News reveals pro-abortion legislative and litigation strategies suggested in the report include:

  • REMS removal strategy (This is the risk management system that governs the abortion pill RU486)
  • TRAP laws removal advocacy
  • Gestational bans removal advocacy
  • Criminality of self-induced abortion removal advocacy
  • Organizing led by women of color (WOC)
  • Reproductive health or democracy reform PAC donations
  • Reproductive justice PAC donations
  • The plan committed to “increasing access for people with low incomes” even “where abortion… becomes inaccessible or is banned completely.”

TARA Health Foundation Abortion strategy

 

#2). Click to Read: Planned Parenthood’s 3-part plan for 2019: Abortion, Abortion, Abortion 

This Live Action News piece, documents that earlier this year, Planned Parenthood released its plan for 2019, and despite  declining clients and health services, the plan reveals the organization’s continued obsession with abortion. The “multi-million dollar” plan was announced by the group’s political advocacy arm, Live Action News reports.
According to PP’s document and the Live Action News article, the largest provider of abortion planned to do the following:

Expand abortion using a Regional Access Network the abortion chain’s plans include:

  • A Regional Access Network anywhere abortion either becomes inaccessible or is banned completely
  • Facilitate telehealth care and transportation for patients facing obstacles to abortion
  • Opening new abortion facilities
  • Expanding medication abortion services
  • Expanding telemedicine services to increase abortion access for clients in remote communities

Legislative efforts to expand tax funded abortion, the plan will target 10 states, including:

  • Illinois, where Planned Parenthood is pushing public funding of abortion and ways the state can “codify the right to abortion in state law”
  • Maine, where Planned Parenthood is “moving to ensure women insured through public programs can have… abortion”
  • Rhode Island. where Planned Parenthood “will work in the 2019 legislative session to codify the right to…abortion in state law”
  • Oregon, where Planned Parenthood “is implementing the Reproductive Health Equity Act to guarantees no-cost coverage for… abortion”
  • Hawaii, where Planned Parenthood “is working to expand access to…abortion by advancing comprehensive coverage of… abortion”
  • Washington, where Planned Parenthood “is focusing on passing the Reproductive Health Equity Access bill” to remove barriers to abortion

Use Hollywood and media to “destigmatize abortion” the plan vows to:

  • Work with “content creators” on portraying abortion positively in film and television
  • Create resources to encourage, “accurate, non-judgmental conversations about abortion…”
  • Use technology to “help people understand the reality of safe, legal abortion and what patients experience when having an abortion”

#3) Click to Read Guttmacher Institute releases plan to expand abortion in 7 ways 

Live Action News documents how, the Guttmacher Institute, Planned Parenthood’s former “special affiliate,” has published a new “policy review,” titled, “Ensuring Access to Abortion at the State Level.
The document is broken down by several strategy subjects:
  • Affirming and Protecting the Right to Abortion
  • Providing Abortion Coverage
  • Ensuring Access to Information
  • Supporting Adolescents’ Access
  • Preventing Clinic Violence
  • Expanding the Pool of Abortion Providers
  • Creating a Safe Policy Environment for Self-Managed Care
  • Expanding Online and Telehealth Access

Paraphrased by Live Action News as follows:

  • 1) Push statutory and constitutional measures to codify abortion
  • 2) Increase taxpayer-funded abortion
  • 3) Force insurance companies to cover abortion
  • 4) Eliminate informed consent 
  • 5) Increase abortion customers
  • 6) Allow non-physicians to commit abortions
  • 7) Push “self-managed abortions”

#4) Advancing New Standards in Reproductive Health (ANSIRH), Gynuity Health Projects, and Ibis Reproductive Health  

According to another Live Action News report, “A consortium of abortion organizations — Advancing New Standards in Reproductive Health (ANSIRH), Gynuity Health Projects, and Ibis Reproductive Health — published a report entitled, “A roadmap for research on self-managed abortion in the United States.” The report suggested, [M]edication abortion could be even further demedicalized through pharmacy dispensing and expansion of telemedicine models—or even making it available over the counter (OTC)—which have the potential to expand access greatly.”

And…what do you know? Abortion organizations are pushing to expand abortion like never before, by attempting to influence the FDA to remove important safety regulations, called REMS which will enable them to sell the dangerous abortion pills online.

The Document claims these groups are planning to: 

  • Expand direct-to-patient telemedicine with various options, such as:
  • Use of phone rather than videoconferencing. 
  • Web-based interface for patient interactions and for recording clinical and research data.
  • Provision of medication abortion pills from a central pharmacy rather than from each clinician’s office.
  • Elimination of the requirement for screening ultrasound and lab tests (i.e., implement screening based entirely on history).
  • Home-based follow-up methods using urine pregnancy testing.
  • Study the uptake, safety, and effectiveness of advance provision of medication abortion pills.
  • Undertake an OTC label comprehension study and develop and implement an actual use study in a simulated OTC environment.
  • Identify ways to improve access in legally restricted settings using data from research with online providers and smartphone apps.

All pro-life groups need to read the abortion weaponization playbooks outlines above.

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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.

Abortion strategy to fund abortion and bio-waste facilities, pass legislation

Posted in Abortion Strategy, ANSIRH, Guttmacher, Reproductive Health Investors Allianc, TARA Health Foundation with tags , , , , , , , , , , , , , , , , , , , , , , on September 6, 2018 by saynsumthn

EXPOSED: Abortion groups’ plan to ‘increase supply and demand’ for abortion

A 92-page report on the Tara Health Foundation website should be reviewed by pro-life advocates across the nation, as it details upcoming strategy from abortion supporters, which includes the push for “home use” abortions. Live Action News has previously covered how the philanthropic Foundation is behind funding RU-486 pills on college campuses in California and behind propping up the abortion chain Whole Woman’s Health while it battled safety regulations in Texas.

The “US Reproductive Health Investment Case” report from October of 2017 was put together by the “Reproductive Health Investors Alliance… to determine the most effective opportunities to improve access to reproductive health services… using both philanthropy and impact investments.” The report’s stated goal? “To increase the supply of and demand for… contraceptive and abortion services.”

Image: TARA Reproductive Health Investors Alliance Goal

TARA Reproductive Health Investors Alliance Goal

Image: Reproductive Health Investors Alliance Steering Committee

Reproductive Health Investors Alliance Steering Committee

The report includes statistics and analysis from “ANSIRH, the Guttmacher Institute, Ibis Reproductive Health, and the Kaiser Family Foundation.”

It should be noted that these agencies have abortion connections:

“Experts” who contributed to the report include:

The executive summary begins by pointing out the target:

… specific demographic groups (18-19 year olds, Black [WOC] and Hispanic women, and low-income women) that lag behind the national average in their rates of contraceptive use, the efficacy of contraceptives used and timing of abortion.

Live Action News has documented time and again that minority groups, which have a disproportionately high rate of abortion, are the target of the population control movement.

Image: TARA Reproductive Health Investors Alliance targeting women of color

TARA Reproductive Health Investors Alliance targeting women of color

The report identifies “40 example investment opportunities,” matched to “five challenge-specific investment strategies”:

a) research and development,
b) legislation & litigation,
c) pricing & reimbursement,
d) service provision, and
e) care-seeking by underserved populations

As Live Action News has documented, the report states that, “~50% of abortions are repeat abortions (460K abortions/year)” and it defines “woman” as those “in need of high quality contraceptive and abortion services” though the report “acknowledge[s] that this is a vast simplification.” The report also adds, “The term ‘woman’ does not describe the identity of all persons who can get pregnant; conversely, not all those who identify as a woman can get pregnant.”

Image: TARA Reproductive Health Investors Alliance legislative strategies

TARA Reproductive Health Investors Alliance legislative strategies

Pro-abortion legislative and litigation strategies suggested in the report include:

  • REMS removal strategy (This is the risk management system that governs the abortion pill RU486)
  • TRAP laws removal advocacy
  • Gestational bans removal advocacy
  • Criminality of self-induced abortion removal advocacy
  • Organizing led by women of color
  • Reproductive health or democracy reform PAC donations
  • Reproductive justice PAC donations

Image: Reproductive Health Investors Alliance abortion clinic strategy 1 of 2

Reproductive Health Investors Alliance strategy 1 of 2

Strategies that benefit abortion facilities include:

  • Investment in a biowaste facility that will collect from the facilities
  • Upstream investment to secure supply of firms able to build the facilities
  • Guarantees that enable the facilities to take out market rate loans
  • Readily available real estate or rental agreements for the facilities
  • Facilitate and train NPs, CNMs, PAs to commit abortions
  • Provide funding or loans for independent providers to join a telemedicine network
  • Innovations in telemedicine, mobile services, or at-home services that improve access
  • Provide free pregnancy diagnosis in abortion facilities to combat pregnancy resource centers

Image: Reproductive Health Investors Alliance abortion clinic strategy 2 of 2

Reproductive Health Investors Alliance strategy 2 of 2

Statistics from report unintentionally point to pro-life advances:

  • Since 2010, 338 state abortion restrictions have been adopted.
  • 90% of all U.S. counties lack an abortion provider.
  • 162 abortion providers closed down between 2011-2016. Only 21 abortion facilities opened during the same period.
  • An estimated 16 abortion facilities close each year due to financial challenges.
  • As of 2008, 97% of nonmetropolitan counties lacked an abortion provider.
  • There are an estimated 2,300 to 3,500 CPCs in the U.S. while there are only 1,800 abortion facilities.
  • Pregnancy resource centers outnumber these facilities 2:1.
  • Cost and difficulty getting malpractice insurance for independent providers is one of the biggest financial challenges for already resource strapped abortion facilities.
  • Viewing an ultrasound may contribute to a small proportion of women with medium or low decision certainty deciding to continue the pregnancy.
  • More than a third of Planned Parenthood’s budget comes from Medicaid, putting Planned Parenthood at risk if Medicaid funding is blocked.

The report proves the length abortion supporters intend to go to in order to guarantee the “right” to end the lives of tiny humans persons in the womb. And it clearly shows the impact that pro-life legislation, pro-life activism, and pro-life pregnancy centers are having on the abortion industry.

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