Editor’s note. On January 3rd of this year, the U.S. Food and Drug Administration (FDA) officially published new rules authorizing appropriately certified pharmacies to stock and distribute abortion pills to women with prescriptions from a certified prescriber. Exactly what this means, and how it affects people in states where there are currently legal protections in place for unborn children and their mothers, are a few of the matters we sought to clarify with Dr. Randall K. O’Bannon, National Right to Life’s Director of Education and Research. Dr. O’Bannon has closely monitored the issue of chemical abortion for nearly thirty years.
Q. Does this mean that abortion pills are now available over the counter at my local pharmacy without a prescription?
A: It is evident that the objective of those who advocate for the use of the abortion pill is to facilitate its availability without restriction. However, at this juncture, the Food and Drug Administration (FDA) has only authorized pharmacies to dispense the medication under strict conditions. It is the responsibility of the pharmacy, whether a brick-and-mortar retail store or an online entity, to certify that they have a designated individual to complete a Pharmacy Agreement Form. This is to ensure that the pharmacy is in compliance with the relevant regulations. This individual is tasked with reviewing the FDA’s prescribing information for mifepristone and is required to verify that they have on file a Prescriber Agreement Form from any healthcare provider sending them a prescription.
In accordance with the stipulations of their certification, pharmacies are prohibited from selling or distributing abortion drugs to individuals who do not possess a prescription from a duly certified prescriber. This precludes the sale of such drugs over the counter or even prescriptions from doctors or other medical practitioners whose identities are unknown to the pharmacy. The drugs are to be delivered to the patient within four calendar days, with the pharmacy tracking and recording all shipments. In addition, the pharmacy is obliged to report all deaths to the prescriber, who is then responsible for notifying the distributor.
A pharmacy that fails to comply with these conditions is not permitted to stock or sell the abortion pills in question.
Q. Will my local CVS, Walgreens, or Rite Aid be stocking and filling prescriptions for the abortion pill?
A: Following the FDA’s announcement, the corporate offices of CVS, Walgreens, and Rite Aid all declared their intention to comply with the certification procedure and stock and distribute the drug. As of the present writing, none have yet claimed to have established the program in any of their drug stores. It is notable that none of the corporations in question had indicated that they had trained the appropriate staff, filled out the required certification forms, set up the database of certified prescribers, or set up the system for shipping and tracking deliveries of pills to patients. It is possible that it may take some time for these corporations to fully set up the system at their stores, to identify and train the appropriate employees, and that some stores and staff may not wish to take part in it. For the time being, the drugstore chains have indicated that they will limit the dispensing of the drugs to stores in states where chemical abortions are permitted by state law. In a recent letter, Walgreens noted that it had not yet decided whether to ship pills by mail (see the last question and answer below).
If you have not yet informed the corporate offices of CVS, Walgreens, and Rite Aid of your opposition to their plans, it is recommended that you do so immediately. It would be prudent to inquire as to whether the sale of abortion drugs is a prudent business decision, particularly in light of the companies’ purported dedication to healthcare.
Additionally, it would be beneficial to contact local CVS, Walgreens, or Rite Aid stores, particularly those in which you have previously conducted business, to ascertain their intentions regarding the announced corporate program. It would be valuable to ascertain their stance on the potential transformation of your local store into an abortion clinic or an abortion pill outlet. It is possible that they are as troubled by the prospect as you and may be willing to collaborate with you in opposing the corporate policy.
Q. Will the FDA’s new authorization override my state law protecting unborn children or otherwise limiting chemical or telemedical abortion? What about the Biden administration legal opinion saying that a long-time federal law prohibiting the mailing of abortion drugs can simply be set aside?
A: The Biden administration has taken a number of actions to assure its pro-abortion constituency that it intends to guarantee women’s access to the abortion pill. On the day that the Supreme Court announced its decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade, Biden’s Attorney General Merrick Garland went out of his way to note that “States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
In addition to the FDA’s authorization for healthcare providers and pharmacies to dispense and deliver mifepristone via mail, the Biden administration’s Office of Legal Counsel issued a memorandum. This memorandum declared that, despite an 1873 federal law specifically and directly prohibiting the mailing of abortifacients, the Justice Department was of the opinion that the Comstock Act—despite being reaffirmed multiple times and still in force—does not prohibit the mailing, or the delivery or receipt by mail, of mifepristone or misoprostol. This is because the shipper’s and recipient’s intentions cannot be presumed.
In parallel, legal challenges have been initiated in federal courts against restrictions on the sale and prescription of mifepristone in West Virginia and North Carolina. GenBioPro is advancing the argument, as previously asserted by Attorney General Garland in June 2022, that state laws prohibiting the use of mifepristone as part of a broader ban on abortion are in conflict with a federal determination of the abortion pill’s safety by the FDA. Similarly, a physician in North Carolina asserts that a state law requiring the abortion pill to be dispensed in person exceeds the regulatory standards deemed adequate for safe use. In each instance, the plaintiffs contend that the issue for the courts is whether the state or the federal government is entitled to determine the parameters of safe drug use.
All of these matters will eventually be resolved in court. However, legal experts have indicated that the Biden administration’s case is weak. The Comstock Law is quite clear in its prohibition on the mailing of abortifacients. Mifepristone mailers rely on the Justice Department’s novel reading of the law, which could potentially lead to legal consequences. Those who mail these pills and rely on the Biden administration’s declaration as their defense will have no recourse if and when a court rejects that argument or when a new administration takes office.
A similar situation may arise in the upcoming dispute between federal and state governments over safety measures limiting the availability of mifepristone. It is a well-established principle of constitutional law that states may enact legislation and adopt policies regarding the safety of drugs, products, and practices that differ from those of the federal government. This is generally permitted in the name of state sovereignty and the Constitution’s Tenth Amendment.
Moreover, although the state may identify several demonstrated safety concerns associated with the use of the mifepristone-misoprostol combination, the 2022 Dobbs decision permits the state to prohibit or regulate abortion as it deems appropriate, in the interest of protecting nascent human life (or any other reason), regardless of whether chemical abortion is or is not proven to be safe.
For further insight on this topic, please refer to the additional questions and answers on this issue available on the www.nrlc.org website. To remain apprised of the latest developments, please click on the “Stay Informed” tab, which will direct you to the “Special Reports” section.
Chelsea Garcia is a political writer with a special interest in international relations and social issues. Events surrounding the war in Ukraine and the war in Israel are a major focus for political journalists. But as a former local reporter, she is also interested in national politics.
Chelsea Garcia studied media, communication and political science in Texas, USA, and learned the journalistic trade during an internship at a daily newspaper. In addition to her political writing, she is pursuing a master's degree in multimedia and writing at Texas.
