Biden FDA Reverses Course and Allows Abortion Pill Through Mail, Posing Serious Health Risk | American Center for Law and Justice
Biden FDA Reverses Course and Allows Abortion Pill Through Mail, Posing Serious Health Risk

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Biden FDA Reverses Course and Allows Abortion Pill Through Mail, Posing Serious Health Risk

By 

Olivia Summers
|

April 27

3 min read

Pro Life

As we anticipated, the Biden Administration is quickly stripping away the pro-life protections that the Trump Administration advanced over the previous four years.

You may recall that last year, during the height of the pandemic, abortion advocates – led by none other than President Biden’s new Secretary of Health and Human Services (HHS), Xavier Becerra – pressured the U.S. Food and Drug Administration (FDA) to expand access to RU-486, also known as the abortion pill. They demanded that the FDA relax its drug safety standards that regulate medications with serious safety concerns, and allow the abortion pill to be prescribed via telemedicine and mailed to women. In turn, the ACLJ sent our own letter to HHS outlining the dangers of the unsupervised dispensing of the abortion pill and pointing out that, of all times, the COVID-19 pandemic was the wrong time to deregulate this dangerous drug.

The abortion pill poses a serious health risk to women, which is why it is regulated in the first place. Administration of the drug is not recommended past 10-weeks gestation, and it is especially unsafe if there is an ectopic pregnancy. To avoid some of the potential complications, an ultrasound is necessary to determine the current stage of pregnancy and eliminate the possibility of an ectopic pregnancy. Even under these regulations, the abortion pill does not work in safe or effective ways nearly twenty-five percent of the time that it is used. Complications from the administration of the pill include, but are not limited to, ruptured ectopic pregnancies, hemorrhage, infection, and retained fetal or other tissue, which require surgery in as many as one in twenty women.

Eliminating the requirement of an in-person visit with a doctor and an ultrasound and allowing the abortion pill to be administered unsupervised only serves to further endanger women. However, that’s exactly what the FDA has now done. In a letter dated April 12, 2021, the FDA’s Center for Drug Evaluation and Research (CDER) announced that it “intends to exercise enforcement discretion during the COVID-19 [pandemic] with respect to the in-person dispensing requirement.”

“Enforcement discretion” means that the CDER is now allowing abortion providers to dispense the abortion pill through telemedicine and mail.

Fortunately, state legislators are fully aware of the attacks against life that are occurring at both the state and federal level.

I recently had the opportunity to testify in support of Maryland House Bill 1198 which would protect Maryland women by continuing to regulate the administration of chemical abortions, even if the federal protections were stripped away.

As I stated in my testimony:

Despite the dangers, if the abortion industry had its way, the FDA’s current REMS protocol would be reversed. In fact, last year abortion advocates attacked the REMS protocol, strategically trying to exploit the COVID-19 crisis to deregulate chemical abortions. A U.S. District Court judge granted a preliminary injunction suspending the FDA’s REMS “in-person dispensing and signature requirements applicable to the prescribing of mifepristone to medical abortion patients.” However, in January 2021, the Supreme Court reversed that decision and upheld the FDA regulations on chemical abortions . . . .

Thus, H.B. 1198 is consistent with Maryland law, Supreme Court precedent, and FDA regulations, and would serve to protect Maryland women by upholding commonsense medical standards by wisely limiting access to these dangerous chemical abortions through telemedicine and remote prescription.

Moreover, I noted that, “according to the FDA, as of 2018, the chemical abortion pill has taken more than 3.7 million preborn lives, caused 24 maternal deaths, and resulted in at least 4,195 reported adverse maternal reactions.” As that information is now over two years old, there have certainly been many more adverse reactions and many more preborn lives lost.

It is clear now, more than ever, that we need to fight to protect life. This is no time for complacency, and the ACLJ is engaged in the fight for life every day. We need to not only stand our ground, but to gain ground. I pointed out in my testimony that according to a recent poll:

[A] large majority of Americans support restrictions on abortion, and “the finding that 70% of Americans either oppose abortion or favor limits on it rather than having it legal under any circumstances is echoed in the large majorities of Americans who have consistently said it should not be legal in the second (65%) and third (81%) trimesters.”

Now is the time for us to make a difference. Join with us; protect preborn lives. Sign our petition because the pandemic should be no excuse to take more lives.

Olivia Summers

More Articles

Olivia Summers is Associate Counsel with the ACLJ, focusing on pro-life advocacy and protecting the freedoms of speech and religion.

Olivia Summers

Olivia Summers is Associate Counsel with the ACLJ, focusing on pro-life advocacy and protecting the freedoms of speech and religion.

PETITION

121,608 Signatures

Stop the Left from Exploiting COVID-19 to Expand Abortion

Read Full Petition
First Name is required
Last Name is required
Email is required
Zip Code is required
Biden FDA Reverses Course and Allows Abortion Pill Through Mail, Posing Serious Health Risk

Biden FDA Reverses Course and Allows Abortion Pill Through Mail, Posing Serious Health Risk

By 

Olivia Summers
|

April 27

3 min read

Pro Life

As we anticipated, the Biden Administration is quickly stripping away the pro-life protections that the Trump Administration advanced over the previous four years.

You may recall that last year, during the height of the pandemic, abortion advocates – led by none other than President Biden’s new Secretary of Health and Human Services (HHS), Xavier Becerra – pressured the U.S. Food and Drug Administration (FDA) to expand access to RU-486, also known as the abortion pill. They demanded that the FDA relax its drug safety standards that regulate medications with serious safety concerns, and allow the abortion pill to be prescribed via telemedicine and mailed to women. In turn, the ACLJ sent our own letter to HHS outlining the dangers of the unsupervised dispensing of the abortion pill and pointing out that, of all times, the COVID-19 pandemic was the wrong time to deregulate this dangerous drug.

The abortion pill poses a serious health risk to women, which is why it is regulated in the first place. Administration of the drug is not recommended past 10-weeks gestation, and it is especially unsafe if there is an ectopic pregnancy. To avoid some of the potential complications, an ultrasound is necessary to determine the current stage of pregnancy and eliminate the possibility of an ectopic pregnancy. Even under these regulations, the abortion pill does not work in safe or effective ways nearly twenty-five percent of the time that it is used. Complications from the administration of the pill include, but are not limited to, ruptured ectopic pregnancies, hemorrhage, infection, and retained fetal or other tissue, which require surgery in as many as one in twenty women.

Eliminating the requirement of an in-person visit with a doctor and an ultrasound and allowing the abortion pill to be administered unsupervised only serves to further endanger women. However, that’s exactly what the FDA has now done. In a letter dated April 12, 2021, the FDA’s Center for Drug Evaluation and Research (CDER) announced that it “intends to exercise enforcement discretion during the COVID-19 [pandemic] with respect to the in-person dispensing requirement.”

“Enforcement discretion” means that the CDER is now allowing abortion providers to dispense the abortion pill through telemedicine and mail.

Fortunately, state legislators are fully aware of the attacks against life that are occurring at both the state and federal level.

I recently had the opportunity to testify in support of Maryland House Bill 1198 which would protect Maryland women by continuing to regulate the administration of chemical abortions, even if the federal protections were stripped away.

As I stated in my testimony:

Despite the dangers, if the abortion industry had its way, the FDA’s current REMS protocol would be reversed. In fact, last year abortion advocates attacked the REMS protocol, strategically trying to exploit the COVID-19 crisis to deregulate chemical abortions. A U.S. District Court judge granted a preliminary injunction suspending the FDA’s REMS “in-person dispensing and signature requirements applicable to the prescribing of mifepristone to medical abortion patients.” However, in January 2021, the Supreme Court reversed that decision and upheld the FDA regulations on chemical abortions . . . .

Thus, H.B. 1198 is consistent with Maryland law, Supreme Court precedent, and FDA regulations, and would serve to protect Maryland women by upholding commonsense medical standards by wisely limiting access to these dangerous chemical abortions through telemedicine and remote prescription.

Moreover, I noted that, “according to the FDA, as of 2018, the chemical abortion pill has taken more than 3.7 million preborn lives, caused 24 maternal deaths, and resulted in at least 4,195 reported adverse maternal reactions.” As that information is now over two years old, there have certainly been many more adverse reactions and many more preborn lives lost.

It is clear now, more than ever, that we need to fight to protect life. This is no time for complacency, and the ACLJ is engaged in the fight for life every day. We need to not only stand our ground, but to gain ground. I pointed out in my testimony that according to a recent poll:

[A] large majority of Americans support restrictions on abortion, and “the finding that 70% of Americans either oppose abortion or favor limits on it rather than having it legal under any circumstances is echoed in the large majorities of Americans who have consistently said it should not be legal in the second (65%) and third (81%) trimesters.”

Now is the time for us to make a difference. Join with us; protect preborn lives. Sign our petition because the pandemic should be no excuse to take more lives.

Olivia Summers

More Articles

Olivia Summers is Associate Counsel with the ACLJ, focusing on pro-life advocacy and protecting the freedoms of speech and religion.

Olivia Summers

Olivia Summers is Associate Counsel with the ACLJ, focusing on pro-life advocacy and protecting the freedoms of speech and religion.

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PETITION

121,608 Signatures

Stop the Left from Exploiting COVID-19 to Expand Abortion

Read Full Petition
First Name is required
Last Name is required
Email is required
Zip Code is required

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