Explainer: Supreme Court hears oral arguments on access to abortion pill
By / Mar 28

This week, the U.S. Supreme Court heard oral arguments on access to an abortion pill in two combined cases—FDA v. Alliance for Hippocratic Medicine and Danco Laboratories, LLC v. Alliance for Hippocratic Medicine. These cases are significant legal battles challenging the U.S. Food and Drug Administration’s (FDA) approval of mifepristone (i.e., the “abortion pill”), a drug commonly used in chemical abortion procedures. In these cases, pro-life doctors have contested the FDA’s approval of mifepristone and its efforts to increase access to this abortion pill.

Though initially challenging the original FDA approval of the drug, the case has now been limited to challenging the subsequent actions of the FDA that removed important safety precautions from the drug’s usage. The lawsuits aim to reinstate these protections for women across the United States, likely significantly impacting the accessibility of chemical abortion (also known as “medication abortion”) nationwide. 

Here is ​​what you should know about the case and the oral arguments on access to this abortion pill

What are those cases about?

In 2016, the FDA:

  • expanded the availability of chemical abortion drugs from 7 weeks of pregnancy up to 10 weeks of pregnancy,
  • changed the dosing regimen,
  • reduced the number of in-person doctor visits from three to one,
  • expanded who could prescribe and administer chemical abortion drugs beyond medical doctors,
  • and eliminated the requirement for prescribers to report nonfatal complications from chemical abortion drugs. 

Then, in 2021, the FDA removed the requirement of in-person dispensing, allowing for abortion pills to be accessed through the mail and telemedicine without a woman ever seeing a doctor in person.

These cases are centered around challenging those actions by the FDA in hopes of reinstating such precautions. Both cases have drawn extensive support and opposition from various groups, including pharmaceutical companies, medical organizations, government officials, rights groups, and experts who have submitted amicus briefs in favor of maintaining or ending the FDA’s approval of mifepristone for medication abortion. (The ERLC submitted an amicus brief in favor of the plaintiffs.)

The U.S. Supreme Court hearing oral arguments on these cases marks a critical moment in the ongoing legal battle surrounding access to medication abortion in the U.S.

What are oral arguments?

Oral arguments are not a requirement for a Supreme Court case. In fact, only about 53–70% of cases accepted by the court each year include oral arguments. But oral arguments provide the public ​​​their first glimpse into what issues or concerns the justices consider most relevant. Observers of the court must be cautious, though, because it’s difficult to impossible to tell how a case will be decided based only on this process.

  • During oral arguments, an attorney for each side of a case is given the opportunity to make a presentation to the court and answer questions posed by the justices.
  • Before this process begins, each side in the case submitted a written legal argument outlining each party’s points of law.
  • The justices will have read these briefs prior to argument and are thoroughly familiar with the case, its facts, and the legal positions that each party is advocating.

As the Supreme Court website notes, “The arguments are an opportunity for the Justices to ask questions directly of the attorneys representing the parties to the case, and for the attorneys to highlight arguments that they view as particularly important.” 

What issues were raised by the justices?

The Supreme Court justices primarily directed their inquiries towards two key aspects of the case:

  • first, whether the physicians who initiated the legal action against the FDA had demonstrated potential harm resulting from the agency’s decisions, given them standing to bring this challenge,
  • and second, whether a causal link could be established between the alleged damages and the FDA’s relaxation of the regulations.

The majority of the argument focused on the issue of whether the doctors who brought the case had proven they were harmed by the FDA’s actions. 

  • Chief Justice John Roberts raised the question of whether the courts had the option to grant limited relief that would solely impact the physicians directly involved in the legal case, rather than pursuing a more expansive approach that would implicate the FDA on a broader scale.
  • Justice Brett Kavanaugh asked whether federal law provides some conscience protections for doctors who object to providing an abortion on moral and religious grounds, to which Solicitor General Elizabeth Prelogar replied, “Yes, we think that federal conscience protections provide broad coverage here.” 
  • Justice Amy Coney Barrett questioned how the doctors who brought the case could be harmed since it didn’t appear that either physician had participated in the procedure.
  • Justice Neil Gorsuch said, “This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly.” 
  • In contrast, Justice Samuel Alito asked who would have the ability to sue the FDA in this case. “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” he asked. “And maybe what they did was perfectly lawful. But shouldn’t somebody be able to challenge that in court?” 

What is the expected outcome based on the reaction of the justices?

Should the court conclude that the doctors lack the necessary legal standing to pursue the lawsuit, it holds the authority to dismiss the case in its entirety without rendering a judgment on the legality of the FDA’s actions when it eased the restrictions surrounding the acquisition of mifepristone.

Observers of the hearing seem to agree that there did not seem to be a majority of five justices who would be willing to issue a sweeping decision that would significantly weaken the FDA’s authority to allow mifepristone to be sent through the mail or without a woman ever seeing a doctor in person.

What happens next?

The court will now spend the next few months writing and deliberating about this case. The final decision will likely come sometime in June. Regardless of how this case is decided, the ERLC will press forward in our fight against the predatory abortion industry and for the cause of life.

Explainer: Supreme Court will hear case restricting chemical abortion drugs
By / Dec 13

On Dec. 13, the U.S. Supreme Court granted certiorari in the FDA v. Alliance for Hippocratic Medicine and will hear oral arguments in the case this term. In August, the 5th U.S. Circuit Court of Appeals ruled that important safety precautions surrounding the use of the chemical abortion drug, mifepristone, must be reinstated, drastically restricting the availability of this harmful drug. 

The 5th Circuit’s decision did not immediately go into effect due to an earlier ruling from the Supreme Court which temporarily allows mifepristone to remain on the market with no restrictions while litigation proceeds. Now, the Supreme Court will weigh in on the merits of this case and make a final decision on upholding or discarding these precautions.

If the court upholds the 5th Circuit’s ruling, it will reinstate key safety measures such as:

  • limiting the use of the drug to the first 7 weeks of pregnancy,
  • ending mail-order chemical abortions,
  • and requiring in-person medical visits prior to the drugs being prescribed.

Chemical abortions account for a majority of all abortions in the U.S., particularly in states where abortion has been restricted or banned following the Dobbs decision. 

What is this case about?

In November 2022, Alliance Defending Freedom filed suit against the FDA on behalf of four pro-life medical groups. The suit claims that the FDA “failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

These pro-life groups argue that the FDA was wrong to grant the drug mifepristone fast-tracked approval back in 2000. The complaint continues:

The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an “illness” and argue that these dangerous drugs provide a “meaningful therapeutic benefit” over existing treatments.

But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.

Currently, 1 in 5 women who take the drug will experience complications that require further medical attention. The case argues that the disposal of original safety precautions that accompanied the drug’s initial approval have led to increased danger to the women and girls who take mifepristone.

In 2016, the FDA:

  • expanded the availability of chemical abortion drugs from 7 weeks of pregnancy up to 10 weeks of pregnancy,
  • changed the dosing regimen,
  • reduced the number of in-person doctor visits from three to one,
  • expanded who could prescribe and administer chemical abortion drugs beyond medical doctors,
  • and eliminated the requirement for prescribers to report non-fatal complications from chemical abortion drugs.  

Then, in 2021, the FDA removed the requirement of in-person dispensing, allowing for abortion drugs to be accessed through the mail and telemedicine without a woman ever seeing a doctor in-person.

At this point in litigation, the court is no longer considering the initial approval of mifepristone but has narrowed its consideration to the removal and potential reinstatement of these vital safety precautions.

What happens next?

This case will now be scheduled for oral argument, likely in early 2024, with a decision expected in June. The court’s previous 7-2 ruling in April was narrowly focused on the availability of mifepristone as litigation proceeded and did not look at the broader merits of the case. It should not necessarily be viewed as a predictor of how the court will rule.

Southern Baptists care about the sanctity of life and dignity of all people, including the preborn. We also care about the health, safety, and welfare of women who have experienced harmful and serious medical complications from these drugs at the hands of the predatory abortion industry. The ERLC is currently evaluating opportunities to file an amicus brief, making these arguments before the court.

If the court upholds this decision from the 5th Circuit, more preborn lives will be saved and more women will be protected from the dangers intrinsic to chemical abortions. We will continue to work toward a day when chemical abortions are no more, and we pray that the Supreme Court will take this step forward as we work to build a true culture of life and to protect the health, safety, and welfare of women and girls.

Explainer: 5th Circuit rules to restrict chemical abortion drugs
By / Aug 16

On Aug.16, the 5th U.S. Circuit Court of Appeals ruled that important safety precautions surrounding the use of the chemical abortion drug, mifepristone, must be reinstated, drastically restricting the availability of this harmful drug. The court’s decision will not immediately go into effect due to an earlier ruling from the Supreme Court which temporarily allows mifepristone to remain on the market with no restrictions while litigation proceeds. It is likely that the Biden administration will appeal this ruling and the Supreme Court will weigh in on the merits of this case.

If upheld, this ruling will reinstate key safety measures such as:

  • limiting the use of the drug to the first 7 weeks of pregnancy,
  • ending mail-order chemical abortions,
  • and requiring in-person medical visits prior to the drugs being prescribed.

Chemical abortions account for a majority of all abortions in the U.S., particularly in states where abortion has been restricted or banned following the Dobbs decision. 

What is this chemical abortion drug case about?

In November 2022, Alliance Defending Freedom filed suit against the FDA on behalf of four pro-life medical groups. The suit claims that the FDA “failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

These pro-life groups argue that the FDA was wrong to grant the chemical abortion drug mifepristone fast-tracked approval back in 2000. The complaint continues:

The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an “illness” and argue that these dangerous drugs provide a “meaningful therapeutic benefit” over existing treatments.

But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.

Currently, 1 in 5 women who take the drug will experience complications that require further medical attention. The case argues that the disposal of original safety precautions that accompanied the drug’s initial approval have led to increased danger to the women and girls who take mifepristone.

In 2016, the FDA:

  • expanded the availability of chemical abortion drugs from 7 weeks of pregnancy up to 10 weeks of pregnancy,
  • changed the dosing regimen,
  • reduced the number of in-person doctor visits from three to one,
  • expanded who could prescribe and administer chemical abortion drugs beyond medical doctors,
  • and eliminated the requirement for prescribers to report non-fatal complications from chemical abortion drugs.  

Then, in 2021, the FDA removed the requirement of in-person dispensing, allowing for abortion drugs to be accessed through the mail and telemedicine without a woman ever seeing a doctor in-person.

Why now?

Though it is unusual that this case is only now being argued over a drug approved 23 years ago, it comes after more than two decades of continued work by the petitioners against the approval of mifepristone.

  • In 2002, the petitioners submitted a citizen petition to challenge the FDA’s approval.
  • It was not until 2016 that the FDA denied the petition.
  • In 2019, the petitioners filed a new citizen petition to challenge the FDA’s 2016 changes.
  • In 2021, on the same day the FDA changed the in-person dispensing requirement, it denied the citizen petition.
  • Following the denial, the petitioners were finally able to file suit against the FDA in November 2022.

What happens next?

This case now likely heads on appeal to the full 5th Circuit and then almost certainly back to the U.S. Supreme Court. The court’s previous 7-2 ruling in April was narrowly focused on the availability of mifepristone as litigation proceeded and did not look at the broader merits of the case. At this time, it is unclear how quickly the court could hear and decide this case.

In anticipation of that ruling, some abortion advocates have already begun to stockpile the drug in anticipation of its potential removal from the market. Others have suggested that the medication abortion protocol could be changed to just include misoprostol, the other drug in the current two-step protocol, even though this practice is known to cause increased cramping, bleeding, and potential complications for women.

Southern Baptists care about the sanctity of life and dignity of all people, including the preborn. We also care about the health, safety, and welfare of women who have experienced harmful and serious medical complications from these drugs at the hands of the predatory abortion industry. 

If upheld, this decision from the 5th Circuit will save more preborn lives and protect women from the dangers intrinsic to chemical abortions. While we will continue to work toward a day when chemical abortions are no more, today’s ruling is a step forward in our work to build a true culture of life and to protect the health, safety, and welfare of women and girls.

How the ERLC represents Southern Baptist churches
By / Jun 9

The Ethics & Religious Liberty Commission (ERLC) exists to assist churches by helping them understand the moral demands of the gospel, apply Christian principles to moral and social problems and questions of public policy, and to promote religious liberty in cooperation with churches and other Southern Baptist entities. As part of that role, we are committed to representing Southern Baptists on issues that hold immense importance for our churches and the gospel. 

One of the ways we fulfill this mission is by actively engaging in the judicial process, particularly at the United States Supreme Court. In this article, we want to update you on the current cases before the Supreme Court, why they matter for Southern Baptists, and how the ERLC is involved.

(For more in-depth analysis, please visit our website at ERLC.com/SCOTUS.)

The Religious Postal Work Case | Groff v. Dejoy

One of the cases we are closely monitoring is Groff v. Dejoy, which revolves around Gerald Groff, a USPS carrier and devout Christian who was denied religious accommodations to observe the Sunday Sabbath. This case has the potential to challenge or limit the 1977 Supreme Court decision in Trans World Airlines v. Hardison, which restricted employers’ obligations to accommodate religious beliefs.

To support Groff and advocate for enhanced religious liberty protections in the workplace, the ERLC has come alongside other religious organizations in filing an amicus brief.

The 303 Creative Free Speech Case | 303 Creative v. Elenis

Another critical case we are following is 303 Creative v. Elenis. It involves Lorie Smith, a creative professional who refused to create a wedding website for a same-sex couple due to her religious convictions. This case raises significant questions about the boundaries of free speech and when the government can compel individuals to express themselves, even if it contradicts their beliefs.

We are actively urging the court to rule in favor of Smith, as it has implications for free speech and the ability of people of faith to live out their convictions in the public square.

The Abortion Pill Case | Alliance for Hippocratic Medicine v. FDA (5th Circuit Decision)

Alliance for Hippocratic Medicine v. FDA is a case brought by pro-life medical groups challenging the FDA’s approval of the chemical abortion drug, mifepristone, and the removal of safety precautions surrounding its usage.

The ERLC has been closely monitoring this case and has advocated for the protection of preborn lives and the well-being of women affected by this harmful drug. We will continue to urge the court to prioritize these critical concerns and will actively seek further engagement if the case is appealed to the Supreme Court.

Stay informed

The ERLC is deeply committed to equipping Southern Baptists with the necessary knowledge to understand court rulings and navigate these vital issues effectively. Recognizing the significance of staying informed and engaging thoughtfully in the public square, we have established a dedicated landing page, ERLC.com/SCOTUS, to equip our churches and fellow Baptists. This platform serves as a comprehensive resource for all the cases we are monitoring, focusing on religious liberty, free speech, and the sanctity of life. Our goal is to empower Southern Baptists to comprehend and respond to these crucial matters.

In our role representing Southern Baptist churches and advocating for our deeply held convictions, the ERLC plays a vital role in addressing key legal cases before the Supreme Court. Through our engagement in cases like Groff v. Dejoy, 303 Creative v. Elenis, and Alliance for Hippocratic Medicine v. FDA, we seek to protect religious accommodations, defend free speech, and uphold the sanctity of life.

As Southern Baptists stand alongside us, we have the opportunity to bring light to a chaotic public square with the transformative message of Jesus Christ. Together, we can make a significant impact on crucial societal issues and ensure that our voices are heard and respected.

TN governor’s Order of Protection proposal, the religious postal worker case, and the abortion pill
By / Apr 21

On this episode, Lindsay Nicolet talks with Hannah Daniel about the Tennessee governor’s Order of Protection proposal. They also discuss several important Supreme Court developments including the religious postal worker case and the abortion pill 

Content

Tennessean: SBC public policy president, a Covenant parent, backs Lee’s gun law proposal

Groff v. DeJoy: Religious postal worker case

  • Rundown of oral arguments

Abortion pill at the Supreme Court 

Connect with us on Twitter

Sponsors

  • Racial unity | If we, as Southern Baptists, can be willing to listen and have good conversations about race, we will see fruit that will draw us closer together. That’s why we believe that A Conversation with Pastor Jon Nelson will be a helpful resource for you and your congregation. Watch this NEW video at ERLC.com/racialunity and listen as Jon candidly shares his thoughts on how we can meaningfully partner together on this work within our churches and communities. Again that link is ERLC.com/racialunity
  • Email updates | Now that 2023 is fully underway, we want to make sure you are kept up to date about the important work we are doing on behalf of Southern Baptists. Whether it’s our 2023 Public Policy Agenda or another ultrasound machine placement, we want to make sure you know how we are serving our churches and acting as missionaries to the public square. As we move forward in 2023, know that first in our hearts and at the top of our minds are our churches. And we are taking those next steps with a Mark 10:44 mindset: to be a servant of all. The best way to learn more is by joining us at ERLC.com/updates. Signing up for email updates allows you to hear directly from us about our work and ways we are serving you on the issues that matter most to Southern Baptists. You’ll learn about our work on your behalf in our nation’s capital, about exciting new partnerships with our state conventions and the ways we are working across the convention with our sister entities. Become an email subscriber at ERLC.com/updates. 

Understanding the Supreme Court
By / Apr 14

On this episode, Lindsay Nicolet talks with Hannah Daniel about the importance of the Supreme Court in today’s society. They also discuss what’s new with the rapidly moving abortion pill case. 

Content

The abortion pill case

Explainer: How a case makes it the Supreme Court

Explainer: What you should know about Supreme Court decisions

Connect with us on Twitter

Sponsors

  • Racial unity | If we, as Southern Baptists, can be willing to listen and have good conversations about race, we will see fruit that will draw us closer together. That’s why we believe that A Conversation with Pastor Jon Nelson will be a helpful resource for you and your congregation. Watch this NEW video at ERLC.com/racialunity and listen as Jon candidly shares his thoughts on how we can meaningfully partner together on this work within our churches and communities. Again that link is ERLC.com/racialunity
  • Email updates | Now that 2023 is fully underway, we want to make sure you are kept up to date about the important work we are doing on behalf of Southern Baptists. Whether it’s our 2023 Public Policy Agenda or another ultrasound machine placement, we want to make sure you know how we are serving our churches and acting as missionaries to the public square. As we move forward in 2023, know that first in our hearts and at the top of our minds are our churches. And we are taking those next steps with a Mark 10:44 mindset: to be a servant of all. The best way to learn more is by joining us at ERLC.com/updates. Signing up for email updates allows you to hear directly from us about our work and ways we are serving you on the issues that matter most to Southern Baptists. You’ll learn about our work on your behalf in our nation’s capital, about exciting new partnerships with our state conventions and the ways we are working across the convention with our sister entities. Become an email subscriber at ERLC.com/updates. 

The forgotten law at the heart of the abortion pill case
By / Apr 14

A 150-year old law that many Americans have never heard of before is at the heart of the recent ruling on the abortion pill. The Comstock Act of 1873 was passed to safeguard public morality by suppressing the distribution and sale of obscene materials—including information on abortion—through the U.S. Postal Service (USPS).

As part of his recent ruling, a federal judge in Texas determined that the Comstock Act prohibits the mailing of chemical abortion drugs. Originally enacted as part of the Comstock Act of 1873, section 1461 currently declares “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” to be “nonmailable matter” that the USPS may not lawfully deliver.

Here’s what you should know about the history and significance of the Comstock Act, and the impact it had on American society and the pro-life cause.

Who was Comstock?

During the mid-19th century, American society was experiencing rapid industrialization, urbanization, and social change. This period saw the rise of new forms of communication that facilitated the spread of ideas and information. The increase of printed materials was of particular concern among religious and social conservatives who worried about the potential for the rapid spread of immoral and corrupting content.

Anthony Comstock, a devout Christian and crusader against vice, was at the forefront of this movement. He believed that obscenity, particularly in the form of erotic literature and contraceptives, posed a threat to the moral fabric of American society. He also viewed abortion as a grave moral evil and sought to restrict its promotion through the dissemination of information. To address these concerns, Comstock lobbied for legislation that would enable the government to suppress the distribution of such materials. 

The Comstock Act, officially titled “An Act for the Suppression of Trade in, and Circulation of, Obscene Literature and Articles of Immoral Use,” was passed by Congress and signed into law by President Ulysses S. Grant on March 3, 1873. The act made it illegal to use the USPS to send or receive any “obscene, lewd, or lascivious” materials, including contraceptive devices and information on abortion. Violators faced severe penalties, including fines and imprisonment.

The Comstock Act expanded the powers of the USPS, granting postal inspectors the authority to search and seize materials they deemed obscene. As the act was broadly worded, it gave inspectors wide discretion in determining what constituted obscenity. The act also allowed for the destruction of any materials confiscated, further limiting the circulation of potentially objectionable content.

Comstock, who was appointed as a special agent of the USPS, used his new authority to lead an aggressive campaign against the dissemination of obscene materials and the promotion of abortion. He claimed to have confiscated and destroyed hundreds of thousands of such items, and his zealous efforts earned him both admiration and criticism.

Challenges, impact, and controversy

The Comstock Act faced challenges from advocates of free speech, who argued that the government’s definition of obscenity was vague and subjective, leading to the suppression of constitutionally protected expression. Critics also pointed out that the act’s provisions on contraception and abortion had little to do with obscenity and instead served to impose a particular moral viewpoint on the public.

From a pro-life perspective, the Comstock Act’s restrictions on abortion information can be seen as an important measure to protect the sanctity of life. By prohibiting the distribution of information on abortion, the Comstock Act effectively limited the accessibility and promotion of a procedure that was harmful to both women and unborn children.

Changes in society’s views of morality, however, brought the act’s provisions on contraception and abortion came under increasing scrutiny. The U.S. Supreme Court, in a series of landmark decisions, began to chip away at the act’s restrictions.

In 1965, the court ruled in Griswold v. Connecticut that a state law banning the use of contraceptives by married couples was unconstitutional, as it violated the right to privacy. This decision marked a turning point in the legal expansion of rights related to individual privacy.

In 1971, the court further undermined the Comstock Act in United States v. Vuitch, which dealt with the issue of abortion. The court held that a District of Columbia law criminalizing abortion except when the mother’s life or health was endangered was unconstitutionally vague. This ruling paved the way for the Court’s landmark 1973 decision in Roe v. Wade, which established the constitutional right to abortion.

These decisions significantly undermined the moral values the Comstock Act was passed to uphold. In particular, the erosion of the act’s restrictions on abortion information and access is believed to have helped lead to a devaluation of the sanctity of life and an increase in the number of abortions performed in the United States.

A mostly forgotten, but enduring legacy

From 1873 until today, the Comstock Act has had a lasting influence on American society, shaping the discourse on morality, censorship, and the sanctity of life for 150 years. The act represented an early and aggressive attempt by the government to regulate the content of printed materials and control access to information on obtaining and conducting an abortion.

The role of government: The act’s legacy can be seen in the continuing debate over the proper role of government in regulating obscenity. Although the Comstock Act’s provisions regarding obscenity have been largely dismantled, the tension between the desire to protect public morality and the need to safeguard individual freedoms remains a central issue in the modern era.

Shaping attitudes: An often unnoticed influence of the act is the role it played in shaping attitudes towards the sanctity of life and the value of children. The restrictions on abortion imposed by the Act contributed to a culture that viewed children as intrinsically valuable and sought to protect preborn children. The struggle to dismantle these restrictions laid the groundwork for the modern pro-life movement, which continues to fight for the protection of preborn children and the promotion of alternatives to abortion.

Although largely forgotten today, the Comstock Act of 1873 was a pivotal piece of legislation that had a profound influence on American society and the pro-life cause. While many of its provisions have been removed or undermined, the act’s legacy remains—as the recent abortion pill ruling shows—relevant to the ongoing debates over abortion in America.

Explainer: Abortion pill case heads to the Supreme Court
By / Apr 12

Note: This case is quickly evolving, and this article will be updated as new developments emerge.

On April 21, the Supreme Court, in a 7-2 decision, paused a lower court ruling from the U.S. Fifth Circuit Court of Appeals that had restricted the availability of the chemical abortion drug, mifepristone, while litigation around its approval is ongoing. Justices Alito and Thomas dissented from the Court’s action. This means that mifepristone remains available without vital safety precautions in place while the case continues. The case now returns to the Fifth Circuit for oral arguments on the merits of the case.

Previously, a three-judge panel at the U.S. Fifth Circuit Court of Appeals ruled on April 12 that mifepristone, part of the two-drug regimen given for chemical abortions, would remain available while litigation regarding its initial approval by the U.S. Food and Drug Administration continues, but also ordered the FDA to reinstate safety precautions such as:

  • limiting the use of the drug to the first 7 weeks of pregnancy,
  • cease sending abortion drugs through the mail,
  • and require in-person medical visits prior to the drugs being prescribed.

That ruling followed an April 7 ruling from a federal judge in Texas which ordered that the FDA’s 2000 approval of the abortion pill, mifepristone, should be halted nationwide. Within an hour, another federal judge in Washington ruled in a separate case that the FDA must continue providing the drug in several states. 

Chemical abortions account for a majority of all abortions in the U.S., particularly in states where abortion has been restricted or banned following the Dobbs decision.

What is this case about?

In November 2022, Alliance Defending Freedom filed suit against the FDA on behalf of four pro-life medical groups. The suit claims that the FDA “failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

These pro-life groups argue that the FDA was wrong to grant the drug mifepristone fast-tracked approval back in 2000. The complaint continues:

The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an “illness” and argue that these dangerous drugs provide a “meaningful therapeutic benefit” over existing treatments.

But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.

Currently, 1 in 5 women who take the drug will experience complications that require further medical attention. The case argues that the disposal of original safety precautions that accompanied the drug’s initial approval have led to increased danger to the women and girls who take mifepristone.

In 2016, the FDA:

  • expanded the availability of chemical abortion drugs from 7 weeks of pregnancy up to 10 weeks of pregnancy,
  • changed the dosing regimen,
  • reduced the number of in-person doctor visits from three to one,
  • expanded who could prescribe and administer chemical abortion drugs beyond medical doctors,
  • and eliminated the requirement for prescribers to report non-fatal complications from chemical abortion drugs.  

Then, in 2021, the FDA removed the requirement of in-person dispensing, allowing for abortion drugs to be accessed through the mail and telemedicine without a woman ever seeing a doctor in-person.

Why now?

Though it is unusual that this case is only now being argued over a drug approved 23 years ago, it comes after more than two decades of continued work by the petitioners against the approval of mifepristone.

  • In 2002, the petitioners submitted a citizen petition to challenge the FDA’s approval.
  • It was not until 2016 that the FDA denied the petition.
  • In 2019, the petitioners filed a new citizen petition to challenge the FDA’s 2016 changes.
  • In 2021, on the same day the FDA changed the in-person dispensing requirement, it denied the citizen petition.
  • Following the denial, the petitioners were finally able to file suit against the FDA in November 2022.

What happens next?

This case now heads back to the U.S. Fifth Circuit Court of Appeal where oral arguments on the merits of the case will be heard on May 17. Some abortion advocates have already begun to stockpile the drug in anticipation of its removal from the market. Others have suggested that the medication abortion protocol could be changed to just include misoprostol, the other drug in the current two-step protocol, even though this practice is known to cause increased cramping, bleeding, and potential complications for women.

Southern Baptists care about the sanctity of life and dignity of all people, including the preborn. We also care about the health, safety, and welfare of women who have experienced harmful and serious medical complications from these drugs at the hands of the predatory abortion industry. Though the Supreme Court’s ruling is a disappointing setback, the fight against medication abortion—and the harms that it brings to women and the preborn—is far from over. We will continue to urge the courts and the FDA to take action that protects women and the preborn.

The state of abortion in 2023
By / Jan 20

In a few days, President Joe Biden will speak before a joint session of Congress and deliver his second State of the Union address. In the message, the president will fulfill his constitutional duty to “give to the Congress Information of the State of the Union, and recommend to their Consideration such measures as he shall judge necessary and expedient.” 

While President Biden might mention abortion in his speech, he is unlikely to discuss the varied ways the issue has changed since the overturning of Roe v. Wade and in the past few months. Here is what you should know about the state of abortion in 2023.

Most abortions are illegal in 14 U.S. states

Earlier this month, the Supreme Courts in Idaho and South Carolina issued rulings on pending cases concerning abortion. In Idaho, abortion is now allowed only to save the life of the mother or in cases of rape or incest. Sadly, in South Carolina the state Supreme Court ruled a 2021 Heartbeat Bill to be unconstitutional, granting the right of an abortion up to 22 weeks.

Abortion is currently banned in 13 states. In Georgia, where a complete ban was blocked by the courts, it is allowed only in the first six weeks. Eleven more states have restrictions between 15 and 22 weeks of gestation. Abortion is legal beyond 22 weeks’ gestation in 25 states and Washington, D.C. 

FDA allows retail pharmacies to offer abortion pill

In the final days of 2022, the U.S. Food and Drug Administration (FDA) updated a rule allowing retail pharmacies like CVS and Walgreens to dispense the abortion pill mifepristone. The change in expanding access to the drug came amid a wave of state efforts last year to impose restrictions. Until 2021, mifepristone could only be dispensed in person by a physician. The Biden administration relaxed that requirement during the COVID-19 pandemic and allowed the drug to be dispensed by telemedicine prescription and mail delivery. That rule was later made permanent. 

The new rule requires pharmacies to apply for a special certification process. The rule also will only apply in states that have not banned abortion. More than a dozen states have laws that would prohibit the abortion pill from being prescribed. However, women will be able to cross state lines and obtain mifepristone from states in which abortion is allowed within the first 10 weeks. 

Medication abortions—abortions that are a result of abortion pills rather than surgery—currently account for more than half of all abortions in the United States, so the ease of access is likely to increase the total number of abortions.  

Justice Department clears Postal Service to deliver abortion pills in states where abortion is banned

A day before Christmas Eve, the Justice Department’s Office of Legal Counsel issued a legal opinion concluding that the mailing of abortion pills does not violate Section 1461 of title 18 of the U.S. Code, commonly known as the Comstock Act. According to the Justice Department, that law does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully.

“Because there are manifold ways in which recipients in every state may lawfully use such drugs, including to produce an abortion,” states the ruling, “the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”

The decision allows abortion pills to be shipped through the U.S. Postal Service as well as by other carriers, like FedEx and the United Parcel Service. But it does not guarantee legal immunity for those involved in sending or receiving abortion drugs in states that restrict them. The opinion also does not prevent state or local prosecutors from using state laws to charge people criminally for violating abortion bans or restrictions.

Congressional Democrats still refuse to protect children born alive after abortion

On Jan. 11, all but two Democrats in the House of Representatives voted against legislation that would require immediate medical attention for babies who are born alive after an attempt was made to abort them. In contrast, 210 Republicans and one Democrat, Rep. Henry Cuellar of Texas, voted to pass the Born-Alive Abortion Survivors Protection Act (one other Democrat, Rep. Vicente Gonzalez of Texas, voted “present”). 

The legislation says that any infant born alive after an attempted abortion is a “legal person for all purposes under the laws of the United States.” Doctors would be required to admit such infants to a hospital for further care. Any violation of this standard could result in fines and imprisonment for up to five years. 

Despite passing by a majority vote in the House, the Democrat-controlled Senate is unlikely to bring the legislation for a vote.

Explainer: The FDA expands abortion pill access in local pharmacies
By / Jan 4

On Jan. 3, the Food and Drug Administration (FDA) issued a regulatory change that allows pharmacy chains and local pharmacies to distribute the first of the two-stage abortion pill regiment known as Mifepristone. 

Why does this matter?

This change will have devastating and widespread effects on preborn children, their mothers, our communities, and likely many pharmacists in abortion-friendly states.

First, there are the obvious and deep concerns about ending the lives of the preborn and grave dangers to women’s health with these medications. Expanded access will mean even more of these life-threatening pills will be available in our communities. While the FDA notes that it does not recommend purchasing mifepristone outside of the Mifepristone REMS Program, the loosening of these rules will inevitably lead to a growing supply and greater demand for the product, especially in states with regulations and bans on the medication.

Alongside issues of human dignity and abortion itself lie increased religious liberty concerns for those employed by pharmacies, especially large retail chains, who may be forced to distribute abortion medications against their conscience as part of their jobs. While some chains provide religious accommodations, it is unknown how many pharmacies in states that allow these medications will seek to protect the conscience rights of individuals who object on religious grounds, particularly in light of the growing push for abortion access today.

What is the ERLC doing on this new rule?

The ERLC has long sought to push back on and seek state/federal solutions to stop expansion and use of these life-taking drugs. For decades, the ERLC and other pro-life organizations worked to prevent the introduction of these pills and have subsequently sought to regulate access ever since. We have made federal regulation on the abortion pill a top priority in our forthcoming legislative agenda.

As we work toward pursuing a culture of life that not only protects the life of the preborn but also cares for vulnerable women and their families, the ERLC remains committed to upholding the dignity of every human life and combating the lies of the predatory abortion industry that benefits from this regulatory change from the FDA.

How do abortion pills work?

In a previous explainer, the ERLC noted that the method approved by the FDA for chemical abortions is a two-step process involving the drugs mifepristone and misoprostol. Mifepristone ends a pregnancy by blocking the hormone progesterone, which is needed to maintain a pregnancy. Because this hormone is blocked, the uterine lining begins to shed, removing the child (in the embryonic state) that was attached. 

The second step, which occurs 24 to 48 hours later, requires taking misoprostol which causes the woman to expel the child and the uterine lining in a matter similar to a miscarriage. The second drug in this regiment is commonly used by doctors and is carried by most pharmacies today, while mifepristone is designed specifically for abortive use and is the main focus of this rule change.

It should also be noted that the FDA authorizes mifepristone to only be taken in the first 10 weeks of pregnancy, although many clinics and medical providers began offering it up to 12 and 13 weeks given the push to expand access to the pill in light of the June 2022 Dobbs decision. According to Pam Belluck of The New York Times, some pills were even made available by prescription to women who are not pregnant but who feel they could use the pills someday. 

What led to this decision?

Following the demise of Roe v. Wade, demand for the abortion pill has grown exponentially, and some have gone to great lengths to obtain it. This regulatory change has been a primary focus of the Biden administration which has been working to expand abortion access since the Supreme Court’s Dobbs ruling last year. Before the current regulatory change to the Mifepristone REMS Program, pregnant women could only legally obtain the medication with a prescription at specially certified clinics, hospitals, or mail-order pharmacies.

In April 2021, the FDA issued a letter stating that it would temporarily stop requiring an in-person visit to prescribe the abortion pill. The change was made permanent in December 2021. These moves followed a January 2021 decision by the Supreme Court to restore a federal rule that required a woman to go to a healthcare facility in person to obtain the drug because of its dangers. 

The FDA’s recent decision removed the in-person requirement from the Mifepristone REMS Program while leaving intact other major requirements that pharmacies will have to meet if they want to distribute this medication, including how the drug “must be prescribed by a health care provider that meets certain qualifications and is certified under the Mifepristone REMS Program” and that “certified pharmacies must ensure mifepristone is dispensed to the patient in a timely manner.” If these requirements are agreed upon and the pharmacy is certified under the program, local drugstores and chains will now have the option to carry mifeprex and its generic mifepristone tablets.

This change will mean expanded access to these life-taking drugs and will be a boon to the abortion industry that has long preyed upon women and their children for profit. Abortion access providers and the abortion industry lauded this decision as a positive step for the public. President and CEO of Planned Parenthood Federation Alexis McGill Johnson celebrated this decision noting that it was a “game changer for people” and “a step in the right direction for health equity.” 

Two manufacturers of this medication, Danco Laboratories, which makes mifeprex, and GenBioPro, which makes the generic version, also released statements acknowledging that the agency had informed them of the action and promoting access to their products. Both applauded the expanded availability to local and national pharmacies, but decried that many will still not have access to these drugs due to the restrictions at the state level.