Since a court ruling threatened the availability of a key drug used in medication abortion, calls have been pouring in to the clinics Adrienne Mansanares oversees.
Patients from near and far are “incredibly worried about whether or not they still have a valid appointment, whether they can obtain the care that they need. It’s heartbreaking,” said Mansanares, president and CEO of Planned Parenthood of the Rocky Mountains, which has clinics in Colorado, New Mexico and Nevada.
For now, the clinics — and many others around the country — are trying to assure patients that nothing has immediately changed while also devising backup plans in case the ruling stands.
U.S. District Judge Matthew Kacsmaryk in Texas said the approval of the drug mifepristone should be revoked, a decision handed down at the same time a federal judge in Washington ordered the government to make the drug more easily accessible. The Supreme Court is expected to eventually settle the matter.
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If mifepristone becomes unavailable, many doctors say they would replace the usual two-drug regimen with a slightly less effective method using only the other drug, misoprostol.
Mansanares said her staff has been sending text messages to patients to make sure they know they can still come in for care.
Clinics are also telling people they're still offering mifepristone — although many providers worry patients will question its safety in the wake of the ruling and news coverage about it. Currently, more than half of all U.S. abortions are medication induced, and some clinics offer no other options.
“Please understand that this judge’s decision does not mean that medication abortion is not safe," Dr. Iffath Hoskins, president of the American College of Obstetricians and Gynecologists, said on a call with journalists this week. “It is safe. It is effective. And it should be an available option for all who seek abortion care.”
Mifepristone, approved by the U.S. Food and Drug Administration in 2000, blocks the hormone progesterone and is also used to treat miscarriages. Millions of women around the world have used the drug, and medical groups say complications occur at a lower rate than with routine medical procedures such as wisdom teeth removal and colonoscopies.
With its future in peril, doctors are laying the groundwork for other safe options.
Mansanares said she and her colleagues pulled together a task force of clinical experts to create a misoprostol-only protocol, “so that if we needed to, we could flip the switch" from the two-drug regimen. She said nearly three-quarters of patients in her health centers choose medication abortions over surgical procedures.
In Pennsylvania, Dr. Becca Simon, a family medicine doctor who provides abortions, said she would also offer abortion procedures and one-drug medication abortion.
The one-drug option is “safe, effective, and actually in some ways can be a little quicker than” the two-drug regimen, said Simon, a fellow with Physicians for Reproductive Health. “It may have some more side effects, but we have medications" to help patients deal with them.
Dr. Gopika Krishna, an OB-GYN in New York and another fellow in the group, said she and her colleagues are still weighing their options but are also considering the one-drug method. She pointed out that it's the subject of recent guidance from national medical organizations, is considered safe by the World Health Organization and is used in other countries where mifepristone isn’t available.
But some doctors said the one-drug regimen is not ideal. The two-drug combination is about 95% to 99% effective in ending a pregnancy. Used alone, misoprostol is less effective. Some research rates it around 85% effective, although other studies say it's closer to that of the two-drug combination.
Dr. Iman Alsaden, medical director of Planned Parenthood Great Plains, said staff at her clinics in Kansas are gearing up to provide misoprostol-only abortions if needed. Consent forms and patient information sheets have been prepared. Staff has been trained.
“It would not be the most medically sound thing to do. But if we have to comply with the law, we will,” Alsaden said.
She’s worried about what could happen if misoprostol fails to end a pregnancy, especially for out-of-state patients driving up to 12 hours for care.
“There’s going to be people that, you know, came to Kansas from Texas, and they don’t have the means or funds or ability to come back,” she said. “And now you’re in a situation where that person is forced to be pregnant.”
Andrea Gallegos, administrator of the Alamo Women’s Clinic in the southern Illinois city of Carbondale, has much the same concern, and is waiting to see how the lawsuits are resolved before making any decisions about what care to offer.
Wisp, a company that provides telehealth medication abortions in nine states, would definitely offer a misoprostol-only regimen if necessary. But spokeswoman Jenny Dwork said the switch would involve website updates and other changes, meaning the company wouldn’t be able to provide their services for around two weeks, “further restricting access to those who need it.”
Q&A: Abortion medication explained
How does medication abortion work?
Medication abortions became the preferred method for ending pregnancy in the U.S. even before the Supreme Court overturned Roe v. Wade. These involve taking two prescription medicines days apart — at home or in a clinic.
Abortion procedures are an invasive medical technique that empties the womb. They are sometimes called surgical abortions, although they don’t involve surgery.
Abortion by pills involves the drugs mifepristone and misoprostol. As more states seek abortion limits, demand for the pills is expected to grow.
Two pills work in combination
Mifepristone is taken first, swallowed by mouth. The drug dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy.
Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. The pill is designed to dissolve when placed between the gums and teeth or in the vagina. It causes the uterus to cramp and contract, causing bleeding and expelling pregnancy tissue.
How late in pregnancy can the drugs be used?
Abortion medication is approved for use up to the 10th week of pregnancy.
The pills may be taken in a doctor’s office or clinic, where patients sometimes have an ultrasound or lab tests beforehand. Some providers also offer the pills through telehealth visits and then send patients the medication by mail.
Use of the pills has been increasing in recent years. As of 2020, they accounted for 54% of all U.S. abortions, according to preliminary data from the Guttmacher Institute. The group’s final estimate is due later this year.
Are the drugs safe? What are the risks?
Studies and real-use evidence show that when taken together, the pills are safe and up to 99% effective. Side effects may include nausea, vomiting and diarrhea.
Bleeding is normal. Very heavy bleeding — soaking more than two pads an hour for more than two hours — is uncommon but requires medical attention.
Dr. Stephanie Rand, a New York ob-gyn and abortion specialist with the advocacy group Physicians for Reproductive Health, says pregnancy tests should not be used right away to determine if a medication abortion was successful because the pregnancy hormone may linger in the body for several weeks. Bleeding, with blood clots that include lighter colored tissue, are signs of success, she said.
Serious complications are very rare. The Food and Drug Administration says more than 3.7 million U.S. women have used mifepristone since it was approved more than 20 years ago. The agency has received 26 reports of deaths in women using the medication, including two involving ectopic pregnancies, which grow outside the womb.
The medications are not recommended for certain patients, including those with suspected ectopic pregnancies or with implanted IUD birth control devices.
What are the costs and rules for use?
Costs vary by location but are similar to abortion procedures and may total more than $500. Health insurance coverage varies, with some plans making the pills free or low cost and others not covering them at all.
Mifepristone is sold under the brand name Mifeprex and misoprostol under the brand name Cytotec, but both pills are available as generics.
The FDA approved mifepristone to terminate pregnancy in 2000, when used with misoprostol. At the time, it imposed several limits on how the drug could be prescribed and dispensed.
In December, the agency dropped the biggest restriction: a requirement that patients pick up the medication in person. The FDA said a scientific review of the drug’s use — including during the COVID-19 pandemic — showed that women could safely receive the pills through the mail after an online consultation, without any increase in side effects or complications.
The decision allowed mail delivery of the pills nationwide, a change long-sought by medical professional groups and abortion-rights supporters.
Still, millions of women will have trouble accessing the pills due to a patchwork of state laws targeting abortion broadly and the pills specifically. About half of U.S. states are expected to ban or greatly restrict abortion.
Will the pills be covered by state abortion bans?
Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.
There are strong arguments and precedents on both sides, experts note, though little certainty about which side might prevail.
The Biden administration’s Justice Department has already signaled plans to challenge state restrictions on medication abortion. And federal lawyers are likely to be joined by outside parties, including abortion rights groups like Planned Parenthood and even the companies that make the pills.
The chief argument against pill restrictions is likely to be the longstanding principle that federal laws, including FDA decisions, preempts state laws. Indeed, few states have ever tried to fully ban an FDA-approved drug because of past rulings in the agency’s favor.
Still, states with blanket abortion bans are likely to interpret them as barring abortion pills. Many of the laws don't distinguish between abortion procedures and medication abortion.
“In the short term, those states that ban abortion are going to assume that their bans also include medication abortion and that will be prohibited,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School.
What is the current situation in the states?
Even if blanket bans are successfully challenged, more than 30 states have laws specifically restricting access to abortion pills. For example, 19 states require that clinicians be physically present when the drug is administered.
Those laws could withstand court challenges. States have long had authority over how physicians, pharmacists and other providers practice medicine.
States also set the rules for telemedicine consultations used to prescribe medications. Generally that means health providers in states with restrictions on abortion pills could face penalties, such as fines or license suspension, for trying to send pills through the mail.
Women have already been traveling across state lines to places where abortion pill access is easier. That trend is expected to increase.
Meanwhile, some women will still get the medication via online pharmacies in Canada and overseas, often with telehealth consultations from foreign doctors. The practice is technically illegal but essentially unenforced, and advocates believe women will increasingly choose this method as more states move to ban abortions.
“Anti-abortion states are going to do everything they can to restrict medication abortion, but practically speaking people have been and will continue to access it through the mail from international pharmacies,” Donley said.
Donley expects lawsuits based on various legal theories to play out for a few years before any clear decisions emerge.
One key question is how the nation’s top court might rule if and when it takes up those court cases. While the Supreme Court has rejected a constitutional right to abortion, conservative justices have also generally deferred to FDA's primacy over drug decisions.
