The states sought removal of the special restrictions on the abortion pill

Medication abortion is still legal in the United States, and it is possible to obtain a prescription from a certified pharmacy under the Mifeprex name

As of Tuesday, the in-person requirement has been permanently removed, according to Danco Laboratories, which markets the drugs under the brand name Mifeprex. It is possible for someone with a prescription to receive the drugs from a certified pharmacy. The updated information was posted Tuesday on the FDA’s website.

Most abortions obtained in the U.S. are done via medication abortion, which has become a hot-button issue in the wake of the Supreme Court’s decision to overturn the Wade decision.

The medications can be taken up to 11 weeks after the first day of a woman’s last menstrual period. Telehealth prescriptions are an option in a few states, and you could visit a state that is legal to get the pills.

Medication abortion is used in more than half of abortions in the US, outpacing surgical procedures for the first time in 2020, according to the Guttmacher Institute, a research group that supports abortion rights.

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.”

In the aftermath of the Supreme Court ruling, Attorney General Garland promised to work with the FDA to protect access to such drugs, which some states have sought to ban.

While no one is required to carry them, pharmacies that wish to dispense the pills would need to meet certain requirements and receive special certification from the FDA. And, in all cases patients still need a prescription. (They will not be available as over-the-counter medications.)

In the current political context, it is not clear whether the US Supreme Court would say that the FDA interfered with state abortion laws, or if they would say state laws do not have to regulate medication abortion.

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.

“At this point, there are still a lot of unknowns in terms of how this is going to play out,” Perritt says. “What we do know is that misoprostol has been used on its own for decades around the world and is effective at ending an early pregnancy.”

Bleeding is a common side effect, though serious complications are very rare. The FDA says more than 3.7 million U.S. women have used mifepristone since its approval.

Training requirements to certify that physicians can provide emergency care in the event of excessive bleeding are part of the FDA mandated safety requirements. A certification is required for the pharmacy that distributes the pills.

Only one pharmacy will seek certification, and there is no indication of what impact it will have on abortion access in places that are restricted or banned.

Walgreens said it would not distribute abortion medication in 20 states because of pressure from anti-abortion lawmakers and lawsuits.

Honeybee Health, an online pharmacy company that had been supplying and shipping abortion medications, posted on its verified Facebook page Tuesday that it “officially became the first pharmacy certified to dispense medication abortion.”

It will take some time for many drugstores to decide if they should go through the certification process.

Is abortion legal? Why do some people in states that have banned abortion do so, and why do they go to a doctor in-person?

There are at least twelve states where an abortion is not permitted, and there is also a lot of states where it is legal. And unfortunately, just like people are forced to do now, it is likely that some people in states where abortion is banned may choose to travel to another state to seek medication abortion,” Miller said.

We don’t think people should be forced to travel like that and there are a lot of smart lawyers who are looking at the question of how they can 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, then that will make it harder to get it for people in states that are banning it.

Many people don’t have time to go to a clinic because of transportation or other reasons, but with this plan they’ll be able to get some care, which will open doors for them.

She added that the FDA’s conclusion that patients are not at an increased risk by not seeing a doctor in-person, might pave the way for providers who may have previously been nervous about seeking certification.

The more lax rules of the pro-life movement were called a “disaster waiting to happen” by Sue Liebel, director of state affairs for Susan B. Anthony Pro-life America.

It’s so irresponsible that the FDA would force an exam on its safety regulations. Liebel told NPR that women’s health and safety was not taken into account.

She suggested that more women would end up in the emergency room. She was not able to point to recent studies that could show an increase in ER calls since the FDA temporarily lifted the in-person mandate.

The next policy session will be very interesting, she said. “We’re in some new territory here with the decision. To be honest with you, the states will try and see what works, but it will be a mixed bag.

Choosing a clinic for medical care: How to go through counseling? The attorneys general’s lawsuit against the FDA in the Washington and Washington cases

There is no data showing that people are going in waves to seek emergency care after they take medication, because there is a great track record showing that they are safe,” she said.

She also notes that clinical care is not going to change very much. “Patients will still be evaluated by experienced clinician. They’ll go through counseling. They’ll be able to talk about whether or not this is the best choice for them.”

She explained that the only difference is that they won’t have to drive long distances for an exam or wait days for vital medication in the most dire situations. “They’re just going to have much more easy access to it.”

A group of attorneys general who control states sued the FDA on Friday in order to get rid of special restrictions that the agency has applied to the first of two abortion drugs.

A lawsuit filed by the 12 states asking for the judge to include orders that would conflict with the actions of the Texas judge in the Washington case, does not address the outcome of the Texas case. The Washington case asks for the court to order the F.D.A. to remove the additional restrictions applied to mifepristone.

Mifepristone is not the only misoprostol-alone drug for abortion at the Trust Women clinic in Wichita, Kansas

At the Trust Women clinic in Wichita, Kansas, it’s already been crisis mode for months. The staff is bracing for a bigger wave of uncertainty according to the clinic director.

Abortion rights opponents are quick to point out that the drug is not used as a medication to induce an abortion because it is approved as an ulcer drug.

“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.

They are coming for the drug Mifepristone or the drug Misoprostol. It will not end with the one medication,” Perritt says. All of this is at risk.

Carafem began offering the single-drug protocol for abortion in 2020 after seeing growing threats to abortion access in general and in particular, Mifepristone.

Patients at Carafem can expect to pay around $200 for the two-drug protocol, compared with about $175 for the only drug. About 10% to 15% of her clients choose to not use the two-drug protocol because it is less expensive, but that number will grow if the regimen becomes unavailable.

Source: https://www.npr.org/2023/02/24/1159075709/abortion-drug-mifepristone-misoprotol-texas-case

The Next Step toward Making Abortion Inaccessible in the United States: Medical Malpractice, Tort Liabilities, and Advocates’ Concern

“We would have one less option, which is not very good,” Grant says. “This is the next step toward making abortion completely inaccessible 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.

Alliance Defending Freedom attorneyErik Baptist thinks that doctors who prescribe the abortion pill could be sued.

The lawsuit isn’t targeting 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. But she worries about an increasingly murky legal landscape surrounding abortion pills.

Retail pharmacies have been caught in the middle of abortion battles. Companies aren’t willing to antagonize lawmakers in states where they may face reprisals. GOP leaders have recently targeted businesses.

Abortion rights advocates have sounded the alarm on the case, stressing that a ruling in favor of the plaintiffs would affect every corner of the country since the lawsuit is targeting a federal agency.

“If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the US would lose access to medication abortion care, an exponential increase in harm overnight,” NARAL said in a statement in February, pointing to internal research.