The FDA and State Laws have a Role in Abortion and Pregnancy: An Update on Misoprostol
After a change to US Food and Drug Administration rules, major pharmacy chains CVS and Walgreens say they plan to seek certification to distribute abortion pills where legally allowed.
The FDA is the one that Congress gives decision-making authority over. And they’re coming in trying to overrule that, saying this medication is unsafe because women bleed. Well, that’s part of having an abortion. It’s also part of having a pregnancy,” said Ryan Brown, an attorney representing Danco in the case. “The bottom line being that they just want to do away with abortion across the board and for any reason.”
Laws vary by state but it is possible to take the medications up to 11 weeks after a woman’s last menstrual period. Telehealth prescriptions are an option in some states, or a person could travel to a state where abortion is legal to get the pills.
According to the Guttmacher Institute, medication abortion is used in more than half of abortions in the United States, compared to surgical procedures.
If a state has banned abortion, medication abortion is not available. She thinks we will see how the FDA has control of drugs and devices in contrast to the state laws. There could be some court cases about this issue of FDA authority and state law.
In the wake of the Supreme Court ruling, Attorney General Garland issued a promise to work with the FDA and other federal agencies to protect access to such drugs, which some states have sought to ban.
The change was partially implemented last year, after the Biden administration said it would no longer force women to pick up medicine in person. Tuesday’s action formally updates the drug’s labeling to allow many more retail pharmacies to dispense the pills, so long as they complete a certification process.
In the current political climate, “it’s far from clear” whether the US Supreme Court would say the FDA’s recent actions “preempt” state laws restricting access to medication abortion, Litman said, or that state laws are preempted to the extent they regulate medication abortion.
Two drugmakers requested the FDA update their labels for their abortion pills. Agency rules require a company to file an application before modifying dispensing restrictions on drugs.
But internationally, the second drug, misoprostol, has been used alone for decades, says Dr. Jamila Perritt, president and CEO of Physicians for Reproductive Health. The case could leave both healthcare providers and patients facing complex medical and legal decisions regarding how to proceed without the drug.
Bleeding is a common side effect, though serious complications are very rare. The FDA says over 3.5 million women in the US have used Mifepristone.
Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the case of excessive bleeding. There is a certification needed by the Pharmacies that deliver the pills.
It is unclear what impact the certification will have on abortion access in places that are banned or restricted.
In a statement Wednesday, Walgreens said it is “working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws.”
“At the onset of the pandemic, Honeybee Health quickly became the first digital pharmacy to supply and ship medication abortion. We are proud to partner with the majority of telemedicine abortion providers in the US and to work closely with our manufacturer to help set the high standards required for certification in response to the FDA’s adjustment to the REMS program,” the Facebook post says. REMS is a program for evaluating the risk of medication.
Probing South Carolina’s Abortion Law with a Medical Cardiac (Carthynology) Diversion Experiment
But for many pharmacies, it will take some time to review and decide whether to undergo the certification process – and the certification process may be complicated.
Right now abortion is illegal in more than a dozen states, it is not legalized in some of them. Miller said that it is possible that people in states where abortion is against the law will go to another state to get a medication abortion.
We don’t believe that anyone should be forced to travel in that way and we know that a lot of lawyers are looking at the question of how that can happen with drugstores and pharmacy chains.
He asked if a state prosecuting someone for diversion would have access to those records. It would be difficult to give it to people in states that are banning it.
When a fetus is detected as a fetal heartbeat, the law prohibits abortions, but exceptions can be made for fetal anomalies and rape.
In a dissent penned by Justice John Kittredge and joined in part by Justice George James, Kittredge wrote that he “would honor the policy decision made by the General Assembly,” adding that the issue of determining abortion policy in the state rests with its elected lawmakers.
South Carolina Republican Gov. Henry McMaster blasted the ruling on Thursday, writing in a statement that the court “has found a right in our Constitution which was never intended by the people of South Carolina.”
“With this opinion, the court has clearly exceeded its authority. The people have spoken through their elected representatives multiple times on this issue. I look forward to working with the General Assembly to correct this error,” the governor said.
The Biden administration is encouraged by South Carolina’s Supreme Court ruling today on the state’s extreme and dangerous abortion ban.
The South Carolina law banning the procedure for six weeks is the subject of a lawsuit filed by three clinics and two providers.
There is a newly proven, promising path to restore and safeguard these rights in many states, including some politically conservative ones controlled by Republicans.
The supporters of abortion rights have made use of the best strategies available to them thanks to the fact that most Americans support access to legal abortion.
While the Department of Justice under the Biden administration has already rejected this argument, that seems unlikely to dissuade antiabortion groups. Their hope is surely to bring their arguments about the Comstock Act to conservative judges—and ultimately, to the conservative supermajority of the US Supreme Court.
But by the time Comstock died in 1915, Americans were having second thoughts about his crusade and courts started to limit the application of the law. The judges said that contraceptives and some drugs could be used for lawful reasons and that the Comstock Act only applied to people who intended to violate the law. That meant that doctors validly prescribing certain medications might be exempt from the Comstock Act, as would patients acting under a physician’s advice.
Some members of the antiabortion movement are pushing for a revival of the Comstock Act, in order to demonstrate their commitment to follow federal law.
Justice Brett Kavanaugh, who holds one of the definitive votes in abortion cases, wrote this summer that the Constitution is “neither pro-life nor pro-choice,” and he is unlikely to reverse course in the near term. But if the Court relies on the Comstock Act, the antiabortion movement might be able to secure the equivalent of a ban on all abortion medication without Kavanaugh having to contradict himself.
It is worth mentioning that the focus on the Comstock act should be a wake up call for those in blue states. The repeal of the law should begin at this time.
Motion to Enforce the FDA’s Approval of Mifeprex: The Case Against the Kacsmaryk Trial
In a statement to NPR, the senior counsel of Alliance Defending Freedom noted that a group of Democratic Attorneys general filed a brief in support of the FDA’s approval of the drug.
Reproductive rights advocates say that if Kacsmaryk sides with the plaintiffs, “it would eliminate the most commonly used method of abortion care,” according to NARAL Pro-Choice America.
If longstanding FDA drug approvals were so easy to stop, the pharmaceutical companies would be unable to depend on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans rely on to treat a variety of health conditions.
“Danco is a small pharmaceutical company. It sells one drug: Mifeprex,” lawyers for the company wrote in court papers. The mandatory preliminary injunction would force the FDA to withdraw approval for Danco’s only product, effectively shuttering the business.
Danco made a similar request to the FDA in an attempt to keep the lawsuit from decimating its business.
He helped make Texas a legal graveyard for the policies of the Biden administration by presiding over 98% of the civil cases brought in Amarillo, Texas.
The most recent attempt to end the program was put on hold last December by Kacsmaryk. He has overseen a number of cases challenging vaccine mandates in Texas, the gender identity guidance issued by the US Equal Employment Opportunity Commission and the use of Covid-19 relief funds for tax cuts.
He worked for a time at the First Liberty Institute, a religious liberty legal group where he worked on briefs for the US Supreme Court.
The case is watched by a number of interested parties, including Republican and Democratic state attorneys general. Two different multi-state coalitions had written letters to the court urging them to act one way or the other.
And a coalition of 22 Republican attorneys general asked the court to issue the preliminary injunction, arguing the FDA exceeded its authority when it approved the medication.
The abortion rights advocates have warned that a ruling in favor of the court would affect all corners of the country, since the suit is against a federal agency.
And activists are mobilizing in Texas around the issue, with the Women’s March planning to hold a rally at the federal courthouse in Amarillo, Texas, on Saturday.
The FDA Response to an Abortion Case in Wichita, Kansas: Single-Drug Arrangements for Medication Abortions
The FDA filed a response to the case on Friday. The case is ripe for judgement due to the fact that all required briefings will have been filed after the deadline extension.
At the Trust Women clinic in Wichita, Kansas, it’s already been crisis mode for months. And now clinic Director Ashley Brink says the staff is bracing for another — maybe even bigger — wave of uncertainty.
Abortion rights opponents are quick to point out that misoprostol is currently approved for use as an ulcer drug — not as a standalone medication to induce abortion.
“Because it is a different procedure than using the two-medication regimen with mifepristone,” Brink says, “we’re having to make sure everyone has the right language and the right information to ensure that they’re communicating that effectively.”
There are downsides, though, including a higher risk of side effects like nausea and cramping, says Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco, who is researching the misoprostol-only protocol.
Leah Coplon, director of clinical operations for Abortion on Demand, a telehealth medication abortion clinic serving 23 states, says her organization is preparing to make the shift to misoprostol-alone if necessary.
Coplon said that the clinic is working on updating the information it gives patients taking the drug. She’s also preparing to order more doses of misoprostol, as well as “comfort medications” to help patients manage any additional pain they might experience with the single-drug protocol.
Carafem began offering a single-drug protocol for medication abortions in 2020 in response to growing threats to the abortion access in general and in particular.
Depending on the location, Grant says the two-drug protocol often costs patients at Carafem around $199, compared with about $175 for the only drug. Grant says about 10% to 15% of her clients choose misoprostol alone, in part because it’s slightly less expensive than the two-drug protocol — a number she expects to grow if the mifepristone regimen becomes unavailable.
Source: https://www.npr.org/2023/02/24/1159075709/abortion-drug-mifepristone-misoprotol-texas-case
The next step towards making abortion completely impossible across the country: Comment on planc pills, mifepristone and misoprostol
Grant says, “We would have one less option, which is not good.” This is the next step to making abortion completely impossible across the country.
Meanwhile, Elisa Wells, co-founder of the group Plan C Pills, which provides information for people seeking abortion medications online, says her organization will continue to point clients toward alternative sources of both mifepristone and misoprostol.
Wells estimates that since the Dobbs v. Jackson Women’s Health Organization decision last year, at least 30,000 people have obtained abortion pills through these networks.
“When it’s prescribed off-label, that puts the doctor or the prescriber in a little more tenuous position when it comes to medical malpractice or tort liability in theory, because it’s never been FDA-approved for that particular purpose,” Baptist says.
An attorney for Alliance Defending Freedom believes doctors who prescribe the abortion pill could open themselves up to lawsuits.
The current lawsuit doesn’t directly target off-label uses. Perritt says that it’s already widely used in procedures that are not labeled for abortion, such as IUD insertion. But she worries about an increasingly murky legal landscape surrounding abortion pills.
In an interview with NPR, Bob Ferguson said that the REMS has only been applied to a few dozen high-risk prescription drugs.
Ferguson says that there will be two federal judges looking at the future of Mifepristone, whether to expand access or not.
“We find it very strange that the same attorneys general who filed a amicus brief in our case two weeks ago are currently arguing in a different court about the exact same thing,” Baptist says.