Access to Misoprostol and Other Abortion Medication without a Doctor’s Visit: The Case for a Two-Year FDA Update

The revision by the FDA announced on Tuesday permanently eliminates the requirement of an in-person doctor’s visit for a prescription of mifepristone, a drug that stops the hormone needed to maintain a pregnancy in the first trimester. The medication has been approved by the FDA for two decades but it has only been available from certified clinics due to safety concerns. Retail chains weren’t allowed to sell the medication.

Andrea Miller, president of the advocacy group National Institute for Reproductive Health, praised the FDA’s changes, calling them an “important step forward” in terms of increasing access to abortion medication – but she said there is “an unfortunate reality.”

The drugs can be taken for up to eleven weeks after the first day of the 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 Guttmacher Institute, medication abortion is used in more than 50 percent of abortions in the US, while surgeries are used in the first time in 2020.

The USPS sought the advice of the OLC about whether federal law precludes the mailing of prescription drugs such as misoprostol.

Attorney General Garland promised to work with the FDA and other federal agencies to protect access to these drugs in the wake of the Supreme Court ruling.

The change could lead to easier access to both stores and online drugs. Women can get a prescription via the internet and then receive the pills in the mail if they choose, but it is up to the law.

The largest abortion-related case since the Supreme court overturned contraceptive use will be decided by a federal judge in Texas.

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.

Dr. Jamila Perritt, president and CEO of Physicians for Reproductive Health says that the second drug, Misoprostol, has been used alone for decades. Perritt says the case could leave both healthcare providers and patients facing complex medical and legal decisions about how to move forward without mifepristone.

There are excessive vaginal bleeding and a lack of strength on the list of more serious side effects of Mifepristone that need immediate medical attention. Still, the physicians and medical societies say medical complications are very rare.

The training requirements that prescribers have to pass in order to give emergency care for excessive bleeding are still in effect. 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.

He said they were evaluating the pharmacy network to see where the products that had extra FDA requirements would be sold and added that they were working through the registration and training of their pharmacists.

“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 stands for Risk Evaluation and Mitigation Strategy.

State and Local Health Policies for Abortion Registration in the United States and New Perspectives for Healthcare Practices – Dr. Susan B. Anthony Pro-life America

It will take a while for a pharmacy to make a decision on whether to go through the certification process.

There are more than a dozen states where abortion is illegal or close to fully illegal, and it is banned. It is possible that people in states where abortion is not allowed will travel to another state to get the procedure, Miller said.

“We don’t believe that anyone should be forced to travel in that way, and certainly, as this moves forward, there are a lot of very smart lawyers who are looking at the question of how they’ll be incorporated into drugstores and pharmacy chains, and where that can happen – and how these different federal and state provisions interplay,” she said.

He asked, “Would a state that was prosecuting somebody for diversion have access to those records? If they do, that makes it harder to provide it to people in states that are banning it.

“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, director of state affairs for Susan B. Anthony Pro-life America, called the new rules a disaster that was waiting to happen.

It is reckless that the FDA would require an in-person exam for these safety regulations. I find it heartless that women’s health and safety was not taken into account,” Liebel told NPR.

She suggested that as a result, more women “will wind up 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.

She said the next policy session is going to be fascinating. “We’re in some new territory here with the decision. t’s going to be a mixed bag to be honest with you in terms of what states will try do and see what works.

“It’s gonna be an adventure!” Brandi told me of her experience with the Trust Women clinic in the initial stages of crisis management

“I would say that there’s absolutely no data that suggests that people are going in waves to seek emergency care after medication and that’s because there is a really great track record showing that they are incredibly safe,” Brandi 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 will be able to discuss the best choice with each other.

She stated that they will no longer have to drive long distances to get an exam or wait days to get vital medication in the most dire situations. They are going to have a lot easier access to it.

It has been crisis mode at the Trust Women clinic for months. Brink said, “The staff is bracing for another wave of uncertainty.”

abortion rights opponents quickly point out that the drug is already approved for use as an ulcer drug, not as a separate drug for inducing abortion.

Transition to Misoprostol-Alone: An Alternative to the Two-Drug Protocol With Mifepristone for Telehealth Medication 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.

They’re coming for Mifepristone, but not for misoprostol. It won’t end with just one medication according to Perritt. All of this is at risk.

Carafem began offering the single-drug protocol at its clinics in Atlanta and Chicago in 2020 amidst growing threats to abortion access in general.

The two-drug protocol is more expensive at locations like Carafem, but cost less at 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

Are doctors responsible for the Dobbs v. Jackson women’s health organization? And why do doctors shouldn’t prescribe the abortion pill?

Grant says that they would have one less option. This is the next step towards making abortion impossible in 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 attorney Eric Baptist thinks that doctors who prescribe the abortion pill could be sued.

The lawsuit doesn’t necessarily target off-label uses. Perritt believes that it is possible to use off-label techniques for procedures like IUD insertion and for abortion. She’s concerned about the legal landscape surrounding abortion pills.

The other pharmacy chains to which Republican attorneys general sent their letters — including CVS, Costco, Walmart, Rite Aid, Albertsons and Kroger — did not immediately respond to NPR’s request for comment about whether they are considering following suit.

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.

The company said in a statement to NPR that it has responded to all of the attorneys general to assure them it won’t distribute mifepristone in their states.