A new path to protect abortion access is the opinion
Prohibiting Access to Abortion through Telemedicine: Comments on a Comstock Act Against the Mailing of Procedural Pills
Lewis Grossman is a professor of law at the American University Washington College of Law.
According to Wells, the only option for people seeking an abortion is alternative sources of pills. There are a lot of products coming into the United States and being distributed within the United States.
Laws vary by state, but the medications can be taken up to 11 weeks after the first day of the last menstrual period. Telehealth prescriptions can be used in some states and a person can visit a state where abortion is legal to get the pills.
This is one of the reasons why anti-abortion groups have gotten so inventive and created new strategies to cut off access to abortion in states where people already decided to guarantee it. An obvious target is abortion pills, which now account for more than half the procedures in the United States.
The Office of Legal Counsel opinion dated December 23, 2022, said that the 1873 Comstock Act “does not prohibit the mailing of certain drugs that can be used to perform abortions where the sender lacks the intent that the recipient of the drugs will use them unlawfully.”
The Attorney General issued a statement promising to work with the FDA and other federal agencies to protect access to certain drugs, which some states have sought to ban.
The change could expand access at both brick-and-mortar stores and online pharmacies. It is possible for women to get a prescription via tele-consultation with a health professional and then receive the pills through the mail.
Does the FDA Have an Impact on Abortion Access in States with Banned or Restricted Abruptness? A Comment on Honeybee Health
“In terms of whether or not that is going to have any impact in states where abortion is banned, I think the answer is probably not,” Grossman said. There is no real effect I see there.
Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs.
Under the current two-drug protocol, the patient first takes mifepristone, which works by blocking progesterone, a hormone that helps a pregnancy progress. What is essentially a medically-inducing miscarried occurs when the second drug in the regimen, misoprostol, causes contraction.
There are often side effects, including bleeding, though serious causes are very rare. More than three million women in the United States have used the drug since its approval, according to the FDA.
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. Pharmacies that dispense the pills also need a certification.
It’s not clear which other pharmacies will seek certification or what impact it will have on abortion access in places where it’s banned or restricted.
Walgreens said in a statement that it was working through the registration and training of its pharmacy staff as well as evaluating where it normally sells products that have extra FDA requirements.
Honey bee Health, an online pharmacy that supplied and shipped abortion medications, posted on its verified Facebook page that it has become the first pharmacy certified to provide medication abortion.
It will take a lot of time to decide whether or not a pharmacy should go through the certification process.
An Attorney General’s Challenge to the South Carolina Supreme Court’s Decision to Uphold the Abortion Law for Six Weeks and a New Plan to Protect Its Importance
It is not possible for states to enforce restrictive abortion laws if they undermine the purpose or objectives of federal law.
“We don’t believe that people should have to travel in that way and certainly, as this progresses, there are a lot of very smart lawyers looking at the question of how they will be incorporated into drugstores and pharmacy chains.”
He asked, “Would a state that was prosecuting somebody for diversion have access to those records? If they do that it will make providing it to people in states that are banning it more difficult.
The 2021 law had banned abortions once what it called a “fetal heartbeat” is detected, which can be as early as four weeks, and more commonly, six weeks into pregnancy, with exceptions for fetal anomalies, risk to the life of the mother, or in some cases of rape or incest. There are more than
While the state can impose some limits on those rights, Hearn wrote, “any such limitation must be reasonable and it must be meaningful in that the time frames imposed must afford a woman sufficient time to determine she is pregnant and to take reasonable steps to terminate that pregnancy.”
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.”
The court clearly exceeded its authority with this opinion. The people have spoken through their elected representatives multiple times on this issue. The governor said that he wants to work with the General Assembly to fix the error.
The White House was positive about the South Carolina decision and wrote on its website, “We welcome the South Carolina Supreme Court’s decision to uphold the state’s abortion ban.”
In July of last year, several providers of abortions in South Carolina, including a hospital and an abortion company, filed a lawsuit against the law that banned the procedure for six weeks.
There is a newly proven, promising path to restore and safeguard these rights in many states, including some politically conservative ones controlled by Republicans.
Most Americans support access to legal abortion so supporters of abortion rights made the most of the best strategies available to them.
In New Mexico, the attorney general asked the state supreme court to block local ordinances that ban abortion and invoke the Comstock Act. This suit could give conservative judges a chance to hold that the Comstock Act is enforceable everywhere, including in blue states.
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 believed contraceptives could be used in a lawful fashion, and that the act only applied to those 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.
The anti abortion movement is trying to get local laws that say they have to follow federal law, like the Comstock Act.
In an opinion this summer, the Supreme Court Justice who holds one of the key votes in abortions wrote that the Constitution is not pro-life or pro-choice. 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.
For those in blue states, this growing focus on the Comstock Act should be a wakeup call. Now is the time to begin working toward the repeal of the law.
The Danco case brought by Kacsmaryk: Defending FDA approvals of the medication Mifeprex in a Texas court filing
The FDA had put restrictions on the drug in order to make it safe and effective, and it asked the court to declare the drug safe and effective.
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.
“More generally, if longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” the FDA wrote.
The company is called Danco. Mifeprex is one drug the company sells, according to court papers. “Entering the mandatory preliminary injunction plaintiffs seek would force FDA to withdraw approval for Danco’s only product, effectively shuttering Danco’s business.”
Danco, which makes mifepristone, also made a similar request to the FDA’s in a court filing, stressing that the lawsuit could decimate the company’s business.
He helped make Texas a legal graveyard for the policies of President Joe Biden, presiding over 98% of the civil cases brought in Amarillo, Texas.
The most recently attempted to end the so-called “Remain in Mexico” program was halted by Kacsmaryk in December. And he has overseen Texas cases challenging vaccine mandates, the gender identity guidance issued by the US Equal Employment Opportunity Commission and the administration’s limits on the use of Covid-19 relief funds for tax cuts.
Before joining the court, Kacsmaryk served as deputy general counsel at the First Liberty Institute, a nonprofit religious liberty legal group, where he worked mainly on “religious liberty litigation in federal courts and amicus briefs in the US Supreme Court,” according to his White House biography.
The case has attracted interest from a number of interested parties, including Republican and Democratic state attorneys general. On Friday two different multi-state coalitions filed briefs with the court urging them to act in a certain way.
The court was asked to issue the preliminary injunction because the FDA overstepped its authority when it approved the medication.
The abortion rights movement is concerned that a ruling by Kacsmaryk in favor of the lawyers would affect all of the country, since the lawsuit is targeting a federal agency.
The Women’s March is planning to hold a rally at the federal courthouse in Amarillo, Texas on Saturday.
Patient education and decision making for misoprostol-only abortion through telehealth: The case of the Trust Women Clinic in Wichita, Kansas
Following the deadline of February 24th, Kacsmaryk said that briefing will be closed on the matter, unless there are extraordinary circumstances.
The Trust Women clinic in Kansas has been through crisis mode for months. And now clinic Director Ashley Brink says the staff is bracing for another — maybe even bigger — wave of uncertainty.
If the judge overturns the approval of that protocol, Brink says the Wichita clinic will only be able to offer patients either a surgical abortion or misoprostol alone. For now, that means preparing the staff with extra training on how to communicate to patients about the impact of the new protocol if they’re forced to make the change.
“Because of the procedure itself, we have to make sure that everyone has the right language and information to communicate it,” Brink says.
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.
The clinic is working to improve 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, an organization that provides medication abortion through telehealth as well as at clinics in Chicago, Atlanta and outside Washington, D.C., began offering the single-drug protocol in 2020 amidst growing threats to abortion access in general and mifepristone in particular.
Depending on the location, Grant says the two-drug protocol typically costs patients at Carafem around $199, compared with about $175 for misoprostol-only. 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
Misoprostol is widely prescribed off-label if it’s approved for miscarriage management, and abortion doesn’t violate the REMS
Grant says that the one less option is not good. The goal is to make abortion completely unavailable 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, the physician is in a more precarious situation when it comes to medical malpractice since it’s never been approved for that purpose by the FDA.
Alliance Defending Freedom attorney Eric Baptist believed that doctors who prescribe misoprostol for abortion could open themselves up to lawsuits.
The current lawsuit doesn’t directly target off-label uses. Perritt of Physicians for Reproductive Health notes that misoprostol is already widely — and safely — used off-label for miscarriage management, in procedures like IUD insertion and for abortion. She is worried about the legal landscape surrounding abortion pills.
In an interview with NPR, Washington state Attorney General Bob Ferguson, who co-led the suit, noted that the REMS has been applied only to a few dozen high-risk prescription drugs — such as fentanyl and other opioids.
Ferguson says that two federal judges might look at the future of the drug and decide whether to expand access or not.
The same attorneys general that filed an amicus brief for us two weeks ago argue that the FDA’s judgments do not need to be second-guessed and have just filed a lawsuit in a different court.
