Online prescriptions of abortion medicines after the reversal of the 2010 US Supreme Court case against misoprostol and mifepristone

The professor of law at the American University Washington College of Law said this was the first time that outpatients were allowed to give mifepristone.

The Supreme Court decision last year to overturn the 40-year-old contraceptives law has made medication abortion a hot topic.

The medications can be taken 11 weeks after the first day of the last menstrual period in some states. Telehealth prescriptions are an option in some states, or a person could travel to a state where abortion is legal to get the pills.

More than half of all U.S. abortions are medically induced through a two-pill regimen that requires a prescription but does not involve surgery. And since Roe v. Wade was overturned in June, rates are expected to increase.

Following the reversal of Roe v. Wade last year, the USPS sought the advice of the OLC on whether federal law prohibits the mailing of mifepristone and misoprostol.

In the aftermath of the Supreme Court ruling, Attorney General Garland issued a statement promising to protect access to such drugs, which states have sought to ban.

The change could allow for more access at online and bricks-and- mortar stores. Women can get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law.

Still, the rule change’s impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts think there will be years of court battles over access to the pills.

There are two drugmakers that make brand-name and generic abortion pills. The agency requires companies to file an application before changing drug restrictions.

“At this point, there are still a lot of unknowns in terms of how this is going to play out,” Perritt says. We don’t know how long it’s been used around the world, but it’s known that it is effective at ending early pregnancies.

Mifepristone Cannot Be Dispensed by States That Are Obscured by the FDA. A Comment on Honeybee Health

A side effect of mifepristone that would require immediate medical attention are excessively heavy vaginal bleeding and unusual tiredness or weakness. The doctors and medical societies say that medical complications are very rare.

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 is not clear which other pharmacies will seek certification or what impact it would have on abortion access in places where it is not allowed.

He added: “We are 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 refers to the Risk Evaluation and Mitigation Strategy program for mifepristone.

It will take time for many pharmacies to make a decision on whether or not to undergo the certification process.

If a state has a law that undermines the objectives of federal law, it cannot be enforced against someone who provides, facilitates access, or obtains medication abortion.

As this move forward, there are a lot of smart lawyers who are looking at the question of how they can be incorporated into drugstores and pharmacy chains, and where that can happen.

He asked if a state that was prosecuting someone for diversion had access to those records. That is a reason to not provide it to people in states that are banning it.

Does the FDA require an in-person exam? The case for abortion pills, according to Dr. Brandi, a spokesperson at the American College of Obstetricians and Gynecologists

“Many people have difficulty accessing this care because of things like transportation or having time off of work to go to a clinic to get this care so this is really going to open the doors for them,” Dr. Kristyn Brandi, a member and fellow at the American College of Obstetricians and Gynecologists told NPR.

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.

Sue Liebel is the director of state affairs for Susan B. Anthony Pro-life America, a pro-life organization that says there is a “disaster waiting to happen.”

The FDA would require an in-person exam in order to peel back the safety regulations. Women’s health and safety were not taken into account, according to Liebel.

She said there will be more women in the emergency room. But when pressed for data that might show any increases in ER visits since the FDA temporarily lifted the in-person mandate, she was unable to point to recent studies.

“I think this next policy session is going to be very fascinating,” she said. “We’re in some new territory here with the decision. It is going to be a mixture of what states will do and see what works.

Source: https://www.npr.org/2023/01/05/1147044290/abortion-pills-should-be-easier-to-get-that-doesnt-mean-that-they-will-be

A lawsuit filed by 12 states seeking the removal of mifepristone from the list of drugs not approved for abortion in the United States

There is no data showing that people are going in waves for emergency care after medication and that’s because there’s a great track record showing that they are very safe.

She stated that clinical care would not 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.”

The only difference, moving forward she explained, is that in the most dire situations they will no longer have to drive long distances for an exam or wait days to obtain the vital medication. They’re going to have very easy access to it.

The attorneys general of a dozen Democratic-controlled states sued the FDA on Friday to get the first of two drugs used in abortion removed from the list of drugs not approved for use in the country.

The new lawsuit filed by the 12 states does not address the possible outcomes of the Texas case, but it requests that the judge’s ruling in the Washington case include orders that would effectively contravene steps that might be imposed by the Texas judge. While the Washington case primarily asks the court to order the F.D.A. to eliminate a framework of extra restrictions applied to mifepristone, the suit also asks the judge to declare that the F.D.A.’s “approval of mifepristone is lawful and valid” and to enjoin the F.D.A. “from taking any action to remove mifepristone from the market or reduce its availability.”

Communication and Abortion on Demand: The Trust Women Clinic’s Next-to-Leading Order of Misoprostol

It’s been crisis mode for months at the Trust Women clinic. 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.

Brink says that it’s important to make sure everyone has the right language and information to communicate effectively because it’s a different procedure than using the two-medication regimen.

The risks of side effects like nausea and sciatic pain are higher with the protocol, according to Dr. Upadhyay.

A director at Abortion on Demand says their organization is ready to switch to a different type of abortion if needed.

The information the patients would receive in regards to the drug is currently being updated by the clinic. 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.

In 2020, Carafem, an organization that provides medication abortions through live video conferences, and at clinics in Chicago, Atlanta, and outside Washington, D.C., will begin offering a single-drug protocol.

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

Prescription Misoprostol is Unconventional and Cannot be Generated for Abortion in the U.S.

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

Plan C pills, co- founders of which provide information for people looking for abortionmedications online, will continue to point clients to alternative sources of both abortion drugs and contraceptives.

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 misoprostol for abortion could be sued.

The current lawsuit doesn’t directly target off-label uses. Perritt of physicians for reproductive health noted that Misoprostol is already widely used off-label in procedures like abortion and IUD insert. She’s concerned about a legal landscape that’s murky around abortion pills.

Retail pharmacies have been caught in the middle of abortion battles. Companies are loath to antagonize lawmakers in states where they may face politically motivated reprisals. GOP leaders have targeted businesses in the past.

The case would affect every corner of the country if a judgement is made in favor of the respondents, said abortion rights advocates.

“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.