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Explainer: The FDA expands abortion pill access in local pharmacies

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January 4, 2023

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. 

Jason Thacker

Jason Thacker serves as a research fellow focusing on Christian ethics, human dignity, public theology, and technology. He also leads the ERLC Research Institute. He is the author or editor of several books including The Age of AI, Following Jesus in a Digital Age, and The Digital Public Square. In addition to his … Read More

Article 12: The Future of AI

We affirm that AI will continue to be developed in ways that we cannot currently imagine or understand, including AI that will far surpass many human abilities. God alone has the power to create life, and no future advancements in AI will usurp Him as the Creator of life. The church has a unique role in proclaiming human dignity for all and calling for the humane use of AI in all aspects of society.

We deny that AI will make us more or less human, or that AI will ever obtain a coequal level of worth, dignity, or value to image-bearers. Future advancements in AI will not ultimately fulfill our longings for a perfect world. While we are not able to comprehend or know the future, we do not fear what is to come because we know that God is omniscient and that nothing we create will be able to thwart His redemptive plan for creation or to supplant humanity as His image-bearers.

Genesis 1; Isaiah 42:8; Romans 1:20-21; 5:2; Ephesians 1:4-6; 2 Timothy 1:7-9; Revelation 5:9-10

Article 11: Public Policy

We affirm that the fundamental purposes of government are to protect human beings from harm, punish those who do evil, uphold civil liberties, and to commend those who do good. The public has a role in shaping and crafting policies concerning the use of AI in society, and these decisions should not be left to those who develop these technologies or to governments to set norms.

We deny that AI should be used by governments, corporations, or any entity to infringe upon God-given human rights. AI, even in a highly advanced state, should never be delegated the governing authority that has been granted by an all-sovereign God to human beings alone. 

Romans 13:1-7; Acts 10:35; 1 Peter 2:13-14

Article 10: War

We affirm that the use of AI in warfare should be governed by love of neighbor and the principles of just war. The use of AI may mitigate the loss of human life, provide greater protection of non-combatants, and inform better policymaking. Any lethal action conducted or substantially enabled by AI must employ 5 human oversight or review. All defense-related AI applications, such as underlying data and decision-making processes, must be subject to continual review by legitimate authorities. When these systems are deployed, human agents bear full moral responsibility for any actions taken by the system.

We deny that human agency or moral culpability in war can be delegated to AI. No nation or group has the right to use AI to carry out genocide, terrorism, torture, or other war crimes.

Genesis 4:10; Isaiah 1:16-17; Psalm 37:28; Matthew 5:44; 22:37-39; Romans 13:4

Article 9: Security

We affirm that AI has legitimate applications in policing, intelligence, surveillance, investigation, and other uses supporting the government’s responsibility to respect human rights, to protect and preserve human life, and to pursue justice in a flourishing society.

We deny that AI should be employed for safety and security applications in ways that seek to dehumanize, depersonalize, or harm our fellow human beings. We condemn the use of AI to suppress free expression or other basic human rights granted by God to all human beings.

Romans 13:1-7; 1 Peter 2:13-14

Article 8: Data & Privacy

We affirm that privacy and personal property are intertwined individual rights and choices that should not be violated by governments, corporations, nation-states, and other groups, even in the pursuit of the common good. While God knows all things, it is neither wise nor obligatory to have every detail of one’s life open to society.

We deny the manipulative and coercive uses of data and AI in ways that are inconsistent with the love of God and love of neighbor. Data collection practices should conform to ethical guidelines that uphold the dignity of all people. We further deny that consent, even informed consent, although requisite, is the only necessary ethical standard for the collection, manipulation, or exploitation of personal data—individually or in the aggregate. AI should not be employed in ways that distort truth through the use of generative applications. Data should not be mishandled, misused, or abused for sinful purposes to reinforce bias, strengthen the powerful, or demean the weak.

Exodus 20:15, Psalm 147:5; Isaiah 40:13-14; Matthew 10:16 Galatians 6:2; Hebrews 4:12-13; 1 John 1:7 

Article 7: Work

We affirm that work is part of God’s plan for human beings participating in the cultivation and stewardship of creation. The divine pattern is one of labor and rest in healthy proportion to each other. Our view of work should not be confined to commercial activity; it must also include the many ways that human beings serve each other through their efforts. AI can be used in ways that aid our work or allow us to make fuller use of our gifts. The church has a Spirit-empowered responsibility to help care for those who lose jobs and to encourage individuals, communities, employers, and governments to find ways to invest in the development of human beings and continue making vocational contributions to our lives together.

We deny that human worth and dignity is reducible to an individual’s economic contributions to society alone. Humanity should not use AI and other technological innovations as a reason to move toward lives of pure leisure even if greater social wealth creates such possibilities.

Genesis 1:27; 2:5; 2:15; Isaiah 65:21-24; Romans 12:6-8; Ephesians 4:11-16

Article 6: Sexuality

We affirm the goodness of God’s design for human sexuality which prescribes the sexual union to be an exclusive relationship between a man and a woman in the lifelong covenant of marriage.

We deny that the pursuit of sexual pleasure is a justification for the development or use of AI, and we condemn the objectification of humans that results from employing AI for sexual purposes. AI should not intrude upon or substitute for the biblical expression of sexuality between a husband and wife according to God’s design for human marriage.

Genesis 1:26-29; 2:18-25; Matthew 5:27-30; 1 Thess 4:3-4

Article 5: Bias

We affirm that, as a tool created by humans, AI will be inherently subject to bias and that these biases must be accounted for, minimized, or removed through continual human oversight and discretion. AI should be designed and used in such ways that treat all human beings as having equal worth and dignity. AI should be utilized as a tool to identify and eliminate bias inherent in human decision-making.

We deny that AI should be designed or used in ways that violate the fundamental principle of human dignity for all people. Neither should AI be used in ways that reinforce or further any ideology or agenda, seeking to subjugate human autonomy under the power of the state.

Micah 6:8; John 13:34; Galatians 3:28-29; 5:13-14; Philippians 2:3-4; Romans 12:10

Article 4: Medicine

We affirm that AI-related advances in medical technologies are expressions of God’s common grace through and for people created in His image and that these advances will increase our capacity to provide enhanced medical diagnostics and therapeutic interventions as we seek to care for all people. These advances should be guided by basic principles of medical ethics, including beneficence, non-maleficence, autonomy, and justice, which are all consistent with the biblical principle of loving our neighbor.

We deny that death and disease—effects of the Fall—can ultimately be eradicated apart from Jesus Christ. Utilitarian applications regarding healthcare distribution should not override the dignity of human life. Fur- 3 thermore, we reject the materialist and consequentialist worldview that understands medical applications of AI as a means of improving, changing, or completing human beings.

Matthew 5:45; John 11:25-26; 1 Corinthians 15:55-57; Galatians 6:2; Philippians 2:4

Article 3: Relationship of AI & Humanity

We affirm the use of AI to inform and aid human reasoning and moral decision-making because it is a tool that excels at processing data and making determinations, which often mimics or exceeds human ability. While AI excels in data-based computation, technology is incapable of possessing the capacity for moral agency or responsibility.

We deny that humans can or should cede our moral accountability or responsibilities to any form of AI that will ever be created. Only humanity will be judged by God on the basis of our actions and that of the tools we create. While technology can be created with a moral use in view, it is not a moral agent. Humans alone bear the responsibility for moral decision making.

Romans 2:6-8; Galatians 5:19-21; 2 Peter 1:5-8; 1 John 2:1

Article 2: AI as Technology

We affirm that the development of AI is a demonstration of the unique creative abilities of human beings. When AI is employed in accordance with God’s moral will, it is an example of man’s obedience to the divine command to steward creation and to honor Him. We believe in innovation for the glory of God, the sake of human flourishing, and the love of neighbor. While we acknowledge the reality of the Fall and its consequences on human nature and human innovation, technology can be used in society to uphold human dignity. As a part of our God-given creative nature, human beings should develop and harness technology in ways that lead to greater flourishing and the alleviation of human suffering.

We deny that the use of AI is morally neutral. It is not worthy of man’s hope, worship, or love. Since the Lord Jesus alone can atone for sin and reconcile humanity to its Creator, technology such as AI cannot fulfill humanity’s ultimate needs. We further deny the goodness and benefit of any application of AI that devalues or degrades the dignity and worth of another human being. 

Genesis 2:25; Exodus 20:3; 31:1-11; Proverbs 16:4; Matthew 22:37-40; Romans 3:23

Article 1: Image of God

We affirm that God created each human being in His image with intrinsic and equal worth, dignity, and moral agency, distinct from all creation, and that humanity’s creativity is intended to reflect God’s creative pattern.

We deny that any part of creation, including any form of technology, should ever be used to usurp or subvert the dominion and stewardship which has been entrusted solely to humanity by God; nor should technology be assigned a level of human identity, worth, dignity, or moral agency.

Genesis 1:26-28; 5:1-2; Isaiah 43:6-7; Jeremiah 1:5; John 13:34; Colossians 1:16; 3:10; Ephesians 4:24