By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Within days of the official January 3, 2023 announcement of Biden administration’s Food and Drug Administration (FDA) that pharmacies would be allowed to stock and sell abortion pills, the nation’s top three pharmacy chains – Walgreens, CVS, and Rite Aid – all announced their intentions to seek the necessary certification to make these available from their stores.
Now, however, some seven months later after the administration’s announcement, the latest we hear is that certification for CVS and Walgreens pharmacies are still in the works — that there are still some details to be worked out before some of their stores begin to make these drugs available (Politico 10/6/23).
Despite pressure from Democrats, other pharmacies at some of the nation’s largest retail chains like Walmart, Costco, Kroger, Safeway, and HealthMart appear to have chosen, at least for a time, to stay out of the fray (CNBC, 6/15/23).
Rite Aid, once thought to be a big player in efforts to bring abortion to local pharmacies, is apparently out of the game or at least sidelined for now; they have just declared bankruptcy and closed many stores (New York Times, 10/19/23).
Meanwhile, GenBioPro, manufacturer of the generic version of mifepristone, says that its drugs are being distributed by several independent pharmacies in the United States that have apparently gotten their certification in order.
Most of these are in states where those state governments have policies and governors who are committed to the promotion and performance of abortion with their borders (Pennsylvania, New York, California, Maryland, Washington); a few are in states where there are some legal protections for unborn children (Texas, South Carolina, Arizona, and Wisconsin). One is an online pharmacy (Honeybee Health) which has been selling mifepristone for a couple of years now. (Full list here.)
Some abortion sympathetic state governments have tried to strong arm pharmacy chains into providing these drugs (“Hochul promises ‘consequences’ if drugstores don’t sell abortion pills: ‘Pharmacies are the new battleground’,” Fox News, 3/1/23). Others have simply taken state funds and stockpiled abortion drugs in case the supply is somehow interrupted (California, New York, Massachusetts, Maryland, and Washington state).
There has been some pushback. Pro-life Attorneys General from twenty states fired off a letter 2/1/23 to Walgreens and CVS. The letter informed them that the sale of abortion drugs was not legal in many of their states and warned them that there was a federal law still on the books that forbade the shipping and mailing of abortifacients – precisely the sort of scheme that the FDA was now attempting to authorize with its latest regulations. (Letter found here.)
Taking the pills to court
The Supreme Court’s Dobbs decision in June of 2022 came at a critical time in the abortion industry’s push for pharmacy distribution and mail delivery of mifepristone. Though the full regulations regarding pharmacy certification were not published until January of this year, the Biden administration announced its intention to make this change in December of 2021.
The Dobbs decision, overturning Roe and giving power to regulate or prohibit abortion back to the states, came in the middle of this process while the FDA was formulating its new rules, giving states new means to fight these deadly pills and setting up new disputes over the rules and conditions in the courts.
These court cases basically fell into two categories–those challenging decisions made by the FDA and those complaining that states lacked the authority to impose different limits on abortion pills than those imposed by the federal government through the FDA, the national drug agency.
The first filed in November of 2022. The Alliance for Hippocratic Medicine v. FDA challenged the original approval of mifepristone and subsequent decisions made by the FDA to loosen restrictions on the abortion pill.
The FDA has imposed certain limits on the distribution and prescription of mifepristone from the beginning. These were codified in 2011 under new REMS rules (“Risk Evaluation and Mitigation Strategy”) regulations for drugs the agency feels come with “serious safety concerns.”
A lower court sustained all these complaints, but the Fifth Circuit said the complaint on approval came too late. The Fifth Circuit allowed only the challenges to reduced regulations made by the FDA in 2016 and 2021 to proceed. That decision is being challenged by the Justice Department and Danco, the abortion pill’s sponsor, to the Supreme Court.
If the Supreme Court goes along with the Fifth Circuit, rules the FDA had in place prior to 2016 would stand. This would not only mean that women no more than seven weeks pregnant (measured from their last menstrual period or LMP) could only get their pills in person from a doctor, but also that distribution or mailing from pharmacies would be out.
A case was filed in February 2023 shortly after the FDA’s most recent decision by several pro-abortion state attorneys general in conjunction with Washington state’s AG. Washington v. FDA sought to get the FDA to drop its special safety regulations entirely.
They argued that mifepristone had already been proven “safe” and “effective” by years of testing and experience. Those attorneys general were unsuccessful in getting the REMS dropped, but the district judge did rule that the FDA could not impose any further regulations on mifepristone and had to make sure the abortion pill remained on the market and available, at least in the filing states.
The generic manufacturer filed suit in January 2023 against the state of West Virginia in federal district court. In GenBioPro v. Sorsaia, it alleged that the state had no authority to restrict a drug which the FDA had already ruled “safe” and “effective” and approved for marketing. The judge in that case ruled that the state could, under Dobbs, limit abortion if it wished, but that it could not outlaw a particular method (like telemedicine) in circumstances (like reported rape) where it allowed abortion.
A similar suit also filed by an abortionist in January 2023 in federal district court in North Carolina. Bryant v. Stein argued that the state could not impose more stringent limits on prescription of abortion pills than those imposed by the federal government agency empowered to regulate drugs. The court has not ruled in that case yet.
If any of these cases advances to the Supreme Court, the justices could decide whether a state could ban a particular form of abortion or regulate the use of a federally approved drug. The High Court could also decide whether to overturn the FDA’s original approval of the drug or whether federal law prevents the mailing or shipping of abortifacients like mifepristone.
Depending on what the court says about any of those elements it could affect either where pharmacies could stock and sell abortion pills or whether these pills could be available on-line, from pharmacies, or by mail at all.
Pharmacies in the near future?
Barring any quick rulings from the courts or some administrative surprise from the FDA, movement still appears to be in the direction of eventual certification for the country’s major pharmacy chains. But there are some developments that could derail that juggernaut.
It is clear from the delays that these corporate pharmacies are finding the certification process more difficult than they might have originally assumed. It is much more than simply filing some short document to qualify the whole corporation at one time.
The rules published by the FDA require that each pharmacy (meaning each separate participating location or store) have a designated person at that pharmacy who will complete the pharmacy agreement form, review the prescribing information (so that they understand how the pills work and the various risks and dangers that accompany them); verify that any prescription come from certified prescribers (who have their own set of qualifications and commitments) whose official FDA prescriber agreements are there on file with the pharmacy; and finally confirm with the prescriber that the drug is appropriate for the patient.
What “appropriate for the patient” means is not fully spelled out. It likely involves, first, confirming that the woman is pregnant and seeking abortion; second, that she has no conditions or “contraindications” that would make the pill particularly dangerous for her; third that she is not more than ten weeks past her last menstrual period (the drug’s effectiveness drops and the likelihood of complications increases with gestational age); fourth that it has been confirmed that she does not have ectopic pregnancy (the pills don’t work in such circumstances); and fifth that she knows what to do in the case of excessive bleeding, failure, or some other medical emergency.
This is a tall order for any prescriber, much less your typical, already harried local pharmacist.
The FDA also requires that these designated employees commit to track and record all shipments and guarantee delivery of the pills to patients within four calendar days, turning any pharmacist who wishes to participate into some sort kind of glorified mail clerk.
Finally, this employee is responsible for reporting any deaths back to the original prescriber. They are to report these to the distributor who is to report these back to the FDA. This is a sobering responsibility for a pharmacist used to passing out life-saving antibiotics and blood pressure medications.
Clearly, this requires a great deal of training and preparation which these corporations have found a challenging task. They must identify a person at each store where they wish to sell the pills, train them, fill out all the paperwork, and also have a filing system set up to track shipments and keep certified prescriber agreements on file.
The FDA’s certification requirements and the challenge involved in CVS and Walgreens efforts to meet them make it clear that this effort to expand the availability to pharmacies will not be a corporate wide affair but that stores will be added on a case-by-case basis. Not every store would be expected to participate. CVS or Walgreens might select one large regional store, for example, or one in a larger city, to be their distribution center for the area. Small town or rural stores are unlikely to be included.
If CVS and Walgreens confine their efforts to states where abortion pills are welcome and heed the warnings of pro-life state attorneys general that the mailing of abortion pills violate federal law, this could mean that only a handful of stores will participate, maybe only in larger cities, in abortion friendly states, and may only handle prescriptions picked up in person, rather than any mail deliveries.
While still tragic for mothers and their unborn babies, this is a far cry from the wide availability that abortion advocates envisioned when the FDA announced these new regulations.
Editor’s note. Part Two be published on Tuesday.