A Sunday Restack: What Comes After Miferpriserone. The Birth Control Pill.

A Prepared Plan to take away Womens Rights

As I read the Project 2025 manifesto by the rightwing republican party. I thought it would be approriate to point out a few things of note worthy reading.

This section begins in Chapter 14-pg: DEPARTMENT OF HEALTH AND HUMAN SERVICES written by Roger Severino under the section of The FDA-Food and Drug Adminstration.

See the radical changes they (The Republican Party) wants to make on Abortion Pills. This section begins on page 456 of the Manifesto.

“Abortion Pills. Abortion pills pose the single greatest threat to unborn children in a post-Roe world. The rate of chemical abortion in the U.S. has increased by more than 150 percent in the past decade; more than half of annual abortions in the U.S. are chemical rather than surgical. The abortion pill regimen is typically a two-part process. The first pill, mifepristone, causes the death of the unborn child by cutting o! the hormone progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes contractions to induce a delivery of the dead child and uterine contents, usually into a toilet at home.”

The abortion-pill regimen is currently approved for up to 70 days (10 weeks) into pregnancy and before Biden was subject to a heightened safety restriction called a Risk Evaluation and Mitigation Strategy (REMS) that requires an in-person visit with a physician who can check for dangerous contraindications such as ectopic pregnancies and can advise the mother seeking an abortion of the risks of chemical abortion, including hemorrhaging, and what to do in such circumstances. Chemical abortion has been found to have a complication rate four times higher than that of surgical abortion. Since its approval more than 20 years ago, mifepristone has been associated with 26 deaths of pregnant mothers, over a thousand hospitalizations, and thousands more adverse events, but that number does not account for all complications. Of course, this does not count the hundreds of thousands to millions of babies whose lives have been unjustly taken through chemical abortion.

FDA should therefore:

• Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. It never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen. Furthermore, at no point in the past two decades has the FDA ever acknowledged or addressed federal laws that prohibit the distribution of abortion drugs by postal mail; to the contrary, the FDA has permitted and actively encouraged such activity.

  Now that the Supreme Court has acknowledged that the Constitution contains no right to an abortion, the FDA is ethically and legally obliged to revisit and withdraw its initial approval, which was premised on pregnancy being an “illness” and abortion being “therapeutically” e!ective at treating this “illness.” The FDA is statutorily charged with guaranteeing the safety and e"cacy of drugs and therefore should withdraw this drug that is proven to be dangerous to women and by definition fatally unsafe for unborn children.

As an interim step, the FDA should immediately restore the REMS by removing the in-person dispensing requirement to eliminate dangerous tele-abortion and abortion-by-mail distribution.

Mail-Order Abortions. Allowing mail-order abortions is a gift to the abortion industry that allows it to expand far beyond brick-and-mortar clinics and into pro-life states that are trying to protect women, girls, and unborn children from abortion. The FDA should therefore:

• Reinstate earlier safety protocols for Mifeprex that were mostly eliminated in 2016 and apply these protocols to any generic version of mifepristone. A bare-minimum policy of limiting abortion pills to the pre-2016 policy of 49 days gestation, returning to the pre-2021 in-person dispensing requirement, and returning to requiring prescribers to report all serious adverse events, not just deaths, to the drug sponsor would increase women’s health and safety

• Address weaknesses in the current FAERS (FDA Adverse Events Reporting System). The Administration and policymakers should ensure that health care workers, particularly those in hospitals and emergency rooms, report abortion pill complications. Women who experience complications from abortion pills typically go to an emergency room, not to the abortion pill prescriber, so putting the onus of reporting on the prescriber who typically has no idea that a complication has occurred means that the FAERS is seriously undercounting adverse events. Submitting an adverse event to the database should be a quick and e"cient process for busy health care practitioners. Currently, providers report that the process is di"cult and convoluted.

• Implement a policy of transparency about inspections of the abortion pill’s sponsors, Danco and GenBioPro, as well as facilities that manufacture the pills. The FDA should respond to congressional requests and Freedom of Information Act (FOIA) requests about inspections, compliance, and post-marketing safety in a timely manner.

• Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.16

Let’s be clear. After Abortion Pills, birth control is next. This is serious, I would encourage all that to read Project 2025: see link below and read for yourself.

https://www.project2025.org/

CellyBlue-I Do Know This!