On January 3, the FDA announced a new certification process for pharmacies to become eligible to sell the abortion pill mifepristone for the first time. This means that people who live in states that have not banned medication abortion may soon walk into their neighborhood pharmacy and leave with their medication in hand. “This brings us one step closer,” said Morgan Hopkins, president of All Above All, “where people can get the care they need in ways that are comfortable, including at a local pharmacy.”
Before the change, certified providers had to stock and distribute the pills themselves or rely on mail order pharmacies that distribute the medication including American Mail Order Pharmacy, Manifest Pharmacy and Honeybee Health. “The FDA’s announcement is a step in the right direction,” said Dr. Ushma Upadhyay, a professor and an expert on the safety and effectiveness of medication abortion. “The science is clear that medication abortion is safe and effective, whether provided in a clinic or at home via telehealth.”
Another Onerous Restriction
Unfortunately, the FDA is now requiring pharmacies to register with the drug manufacturer to distribute the drug, a drug that, by the way, is safer than Tylenol. This certification is not supported by medical evidence and will possibly present a large enough hurdle to dissuade some pharmacists from dispensing. The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians have all issued statements opposing the restrictions and certification requirements.
Pharmacy chains CVS and Walgreens have said they will seek certification to sell abortion pills in states where it is legal. In Nevada County, while we are waiting, there are two ways to receive the pills. The Clinic! orders them in bulk and has them available in the offices, or providers may send an RX to American Medical Mail Order Pharmacy though they may only pay in cash or through a private insurer. Medical’s system has not yet been updated, according to Cindy Xiong at Women’s Health Specialists.
The Post Office Can Deliver Abortion Pills by Mail
Last November, conservative legal group Alliance Defending Freedom [sic] filed a federal lawsuit asking a Texas court to ban abortion pills from the U. S. Mail. The suit cited an archaic 19th century law called the 1873 Comstock Law. Named after and promoted by virulent anti-vice crusader Anthony Comstock, initially to stop Margaret Sanger and her supporters from sending birth control information through the mail, it banned sending “obscene” literature, contraceptives, abortifacients or any sexual information through the U. S. Mail.
In response to a request for clarification from the U. S. Postal Service, the Department of Justice’s Office of Legal Counsel issued an opinion made public on January 3 stating that the Comstock Law does not prohibit mailing abortion pills if the sender does not know that the medications will be used illegally. Therefore, even when a sender or a deliverer of mifepristone or misoprostol, including USPS, knows that a package contains such drugs—or that they will be used to facilitate an abortion—such knowledge alone is not a sufficient basis for concluding that the law has been violated. The decision applies to USPS, UPS and FedEx.
WAIT, WHAT?
Just when you think it is safe…Right now there is an abortion rights case so big it could go before the Supreme Court. A conservative Texas federal judge, Matthew Kacsmaryk, appointed to the bench by former President Trump, will be hearing the case to outlaw mifepristone, approved by the FDA 23 years ago. Kacsmaryk has been called the “most lawless jurist in the country.” The “busy man” has seized control over border policy, repeatedly defied the Supreme Court’s decision protecting LGBTQ employees and restricted minors’ access to birth control.
Attorneys and Slate reporters Dalia Lithwick and Mark Joseph Stern have pointed out three massive flaws in the case: First, none of the plaintiffs “have an ability to sue in federal court.” And in order to do so, they would need to prove that the FDA’s approval of mifepristone “injures them personally.” Second, the “substantive arguments are ridiculous,” because they dispute the conclusions of the FDA’s scientists.” Third, a federal judge has never banned a drug “by wholly revoking FDA approval.”
Even with these three glaring flaws, “the actual enduring problem,” write Lithwick and Stern, is that the lawsuit “stands a significant chance at succeeding.” Lithwick writes that the newly constituted Supreme Court has already brushed aside standing requirements in order to weaken civil rights laws and the EPA and the CDC.
The Chaos and Cruelty is the Point
It is no coincidence that this lawsuit, brought by the Alliance for Hippocratic Medicine v. FDA (was that hypocritical medicine?) appeared almost immediately in the wake of Dobbs. It is about much more than medication abortion. In addition to challenging access to medication abortion nationwide, including in California, the lawsuit threatens the FDA’s authority of the drug approval process generally. This threatens the agency’s power to regulate any medical space well beyond abortion and reproductive health care.
This could mean that access to mifepristone would be eradicated in every state in the country including states where the right to abortion is protected, including our state of California.
Both Lithwick and Stern assert that perhaps the overturning of Roe v. Wade was not the terminal point in the attack on women’s reproductive rights, but, instead, “barely even the start.” Could this case be the next abortion rights case the Supreme Court puts on its docket.
**UPDATE TO STATUS OF LAWSUIT!**
Because of an extension order issued on Saturday, 2/11, there will be two more weeks before the possibility of a decision in Alliance for Hippocratic Medicine v. FDA, the federal court case that could revoke FDA approval of mifepristone and remove it from the market nationwide. The judge may now issue a decision at any time after February 24. This delay is not a bad thing as it gives activists more time to prepare.
