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Biden And The FDA Push New Chemical Abortion Protocols That Endanger Women

Americans should demand answers as to why Joe Biden and the FDA are making the abortion pill riskier for women.

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President Biden is bringing to bear the full institutional power of the federal government to promote access to dangerous chemical abortion pills.

A White House memo released on Sunday directed the Department of Health and Human Services, the Department of Homeland Security, and Attorney General Merrick Garland to issue guidance telling patients and pharmacies how they can obtain chemical abortion pills in states where abortion is either illegal or restricted. The president has also called on federal departments and agencies to draw up recommendations for removing “potential barriers” to abortion pill access.

Earlier this month, the U.S. Food and Drug Administration (FDA) formally dropped the requirement that abortion pills be administered, in person, by qualified medical personnel. It also moved to allow pharmacies to fill prescriptions for the pill — a seismic change in policy that could soon turn your local pharmacy into an abortion pill dispensary.

Both changes endanger women’s health.

Abortion with pills involves taking two different drugs in succession. The first drug, mifepristone, typically kills the unborn child by blocking essential progesterone. The second drug, misoprostol, induces contractions to expel the unborn child from its mother’s womb. Both drugs carry risks.

The FDA approved mifepristone in 2000 but considered the drug’s risk profile so high as to warrant special heightened monitoring and risk management practices. The agency, therefore, established a Risk Evaluation and Mitigation Strategy (REMS) program — a strict protocol governing the administration of mifepristone.

To prescribe the drug, doctors had to meet special requirements. These included the ability to accurately assess the gestational age of the unborn child, the ability to diagnose ectopic pregnancies, and the ability to surgically remove tissue from an incomplete abortion or provide access to emergency resuscitation treatment if necessary. The REMS originally also required two mandatory in-person visits by the patient for administering the two-drug abortion pill regimen as well as a mandatory follow-up visit to ensure no serious complications resulted. Doctors were also originally required to report all serious adverse events to the FDA.

But in 2016, the FDA started allowing non-physicians who met the qualifications to begin prescribing mifepristone. They also removed the requirement for in-person office visits or physical exams prior to having an abortion, keeping only a mandatory follow-up visit in place. The requirement that the pill be administered in person by a certified prescriber remained.

That changed with the pandemic. In July 2020, the FDA temporarily suspended the requirements for in-person administration of the pill and a mandatory follow-up visit. The FDA’s January update of the mifepristone REMS makes these pandemic-era changes permanent.

Additionally, the FDA is moving to expand access to abortion by allowing pharmacies to fill prescriptions for abortion pills. Retail pharmacy giants CVS and Walgreens and online pharmacy Honeybee Health have announced their intent to sell them in states where abortion is legal.

This is all bad news not just for the unborn, but also for women’s health.

Risks of Removing Mandatory Follow-Up Exams

By removing the mandatory follow-up visit requirement, the FDA has made it optional for abortionists to check for post-abortion complications.

That is not because post-abortion complications are not happening. Indeed, abortion pills have more complications than surgical abortion. A study of Swedish women from 2008-2015 found that, on average, 7.3 percent of women had a post-abortion complication such as excessive bleeding, incomplete abortion, or infections after using the abortion pill within 12 weeks of gestation. By comparison, the complication rate for surgical abortion was 5.3 percent.

In the U.S., a recent study in states where Medicaid dollars are used to pay for elective abortions found that Medicaid-eligible women using the abortion pill had a 53 percent greater odds of making an abortion-related visit to the ER than similar women who had surgical abortions.

If we assume women today experience serious complications from the pill at the same rate as seen during U.S. clinical trials, that would put the number of women admitted to the hospital for pill-related reasons between 197 and 2,958 a year.

Risks of Removing the In-Person Pill Administration Requirement

The FDA-updated REMS also makes it optional for abortionists to conduct physical exams prior to prescribing these dangerous drugs. Yet, without an exam, it is not possible to effectively screen for ectopic pregnancies — a potentially life-threatening condition if not detected and treated in time.

The FDA warns that women should not take mifepristone if they have an ectopic pregnancy. But an in-person physical examination using ultrasound, bloodwork, or laparoscopy is needed to rule out the possibility of an ectopic pregnancy, according to Medscape.

Symptoms of a ruptured ectopic pregnancy, such as prolonged or heavy bleeding and abdominal pain, can be similar to the side effects of taking the abortion pill. If an ectopic pregnancy ruptures after taking the abortion pill, the woman may mistake this potentially life-threatening condition as “normal” side effects. Consider, also, that most pill-induced abortions are done at home with no knowledgeable medical staff on call. For the unfortunate few who could find themselves in this situation, this is a recipe for disaster.

Americans should demand answers as to why the FDA has made the abortion pill riskier for women. Congress should demand answers as well, using its oversight powers to hold the FDA accountable. The more fundamental question, of course, is: Why has the FDA authorized a drug that is designed to kill unborn children in the first place?

Pro-life Americans should move their prescriptions to their local grocery store or non-mifepristone-dispensing pharmacies.


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