By Dave Andrusko
Editor’s note. This appears in the March edition of National Right to Life News. Please share this story, and many others, with your pro-life family and friends.
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?
No. While that is clearly the ultimate aim of abortion pill promoters, at this point the FDA only authorized pharmacies to dispense these under strict conditions. That pharmacy, whether a brick-and-mortar retail store or an online entity, must certify that they have a designated person to complete a Pharmacy Agreement Form to ensure pharmacy compliance. This person is to review the FDA’s prescribing information for mifepristone and is required to verify that they have, on file, a Prescriber Agreement Form from any health care provider sending them a prescription.
Under the terms of their certification, the pharmacy is not to sell or distribute the abortion drugs to anyone who does not have a prescription from a verified certified prescriber; this rules out over-the- counter sales or even prescriptions from doctors or other medical agents unknown to the pharmacy. Drugs are to be delivered to the patient within four calendar days, with the pharmacy tracking and recording all shipments. The pharmacy is also responsible for reporting all deaths to the prescriber who is to report these to distributor.
A pharmacy which does not agree to comply with these conditions is not authorized to stock and sell these abortion pills.
Q. Will my local CVS, Walgreens, or Rite Aid be stocking and filling prescriptions for the abortion pill?
A. After the FDA announced its decision, corporate offices of CVS, Walgreens, and Rite Aid all announced their intentions to comply with the certification procedure and stock and distribute the drug. As of this writing, none have claimed to have set up the program in any of its drug stores yet. That is, none 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 may take some time for these corporations to fully set up the system at it stores, to identify and train the appropriate employees, and some stores and staffs may not wish to take part in it. For now, the drugstore chains have said they will confine their dispensing of the drugs to stores in states where these chemical abortions are allowed by state law. Walgreens noted in a recent letter that it had not yet decided whether to ship pills by mail (see the last question and answer below).
If you haven’t let the corporate offices of CVS, Walgreens, and Rite Aid know of your opposition to their plans, do so immediately. Ask that they consider whether selling abortion drugs is good business, much less an appropriate activity for a company supposedly devoted to healthcare.
But also contact your local CVS, Walgreens, or Rite Aid stores, particularly ones where you might previously have done business, and find out whether they intend to participate in the announced corporate program. Find out how they feel about turning your local store into an abortion clinic or an abortion pill outlet. You may find that they are as troubled by the prospect as you and could use your support in fighting against 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 means to guarantee women’s access to the abortion pill.
On the day that the Supreme Court announced its Dobbs decision overturning Roe, 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 actions by the FDA allowing both health care providers and pharmacies to dispense and deliver mifepristone by mail, the Biden administration’s Office of Legal Counsel issued a memo. This memo declared that, in spite of 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…”because the shipper’s and recipient’s intentions cannot be presumed.
Meanwhile, lawsuits have been brought in federal court against limits imposed on the sale and prescription of mifepristone in West Virginia and North Carolina. GenBioPro is arguing, as Attorney General Garland asserted in June of 2022, that state law prohibiting the use of mifepristone as part of a larger ban on abortion conflicts with a federal determination of the abortion pill’s safety by the FDA. Similarly, a doctor in North Carolina says that a state law requiring the abortion pill to be dispensed in person goes beyond regulations the agency says are sufficient for safe use. In each case, plaintiffs argue that the issue for the courts is whether the state or the federal government is entitled to declare what constitutes safe use of the drugs.
All these matters will eventually be resolved in court, but legal experts say the Biden administration’s case is weak. The Comstock Law is pretty direct in its prohibition on the mailing of abortifacients. Mifepristone mailers rely on the Justice department’s novel reading of the law at their own legal peril. Anyone mailing these pills and counting on the Biden administration’s declaration as their defense will have nowhere to turn if and when a court rejects that argument or when a new administration takes office.
Much the same can be said regarding the upcoming tussle between federal and state governments over safety measures limiting the availability of mifepristone. States can and have had different laws and opinions regarding the safety of different drugs, products, and practices than the federal government and these have generally been allowed to stand in the name of state sovereignty and the Constitution’s 10th amendment.
Furthermore, even though the state may raise several demonstrated safety issues associated with use of the mifepristone-misoprostol combination, the 2022 Dobbs decision allows the state to ban or regulate abortion as it sees fit, 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.
Additional Questions & Answers on this issue can be found on the www.nrlc.org website. Click on the “Stay Informed” tab under which you’ll find “Special Reports.”