Prescription Denied: Accessing The Abortion Pill
For decades the abortion pill has been one of FDA’s most restricted drugs. Newsy investigated why and what impact that has had on access.
It was a cold and rainy December morning in southern Mississippi. A woman we are calling “S” and her husband began their three-hour drive to Jackson to visit the state’s only clinic that performs abortions.
“I was drained emotionally and physically. I was still just very anxious until we started talking for a little bit in the car,” she said. Playing music and pointing out billboards served as a distraction.
S and her husband before taking Newsy reporters on the three-hour drive they took in 2018 to the last abortion provider in Mississippi. (Zach Cusson / Newsy)
It was the first of multiple trips the married couple would take to access a medication abortion, a method using pills to terminate a pregnancy. They’re anonymous because they fear retaliation from their families who oppose abortion.
“We went over the pros and cons of keeping the pregnancy,” S said.
This isn’t the first time “S” has been pregnant. A few years earlier she had a difficult pregnancy with her daughter and received treatment for postpartum depression.
“With the horrible horrible experience I had giving birth to my daughter, I mean I couldn't even mentally handle, like going through a cervical check,” S recalled. “So I wanted to do a medical if at all possible.”
A medical or medication abortion uses two drugs to terminate a pregnancy. The first drug, mifepristone, blocks a hormone to induce the abortion. The second drug, Misoprostol, completes it by expelling the pregnancy. But mifepristone, which for medication abortion goes by the brand name Mifeprex, is among the most restricted drugs in the U.S. which makes it challenging to get.
A Newsy investigation has found mifepristone has a better safety record than penicillin and Viagra. Yet, unlike those medications, you can’t get the abortion pill at a pharmacy with a prescription. That’s because the Food and Drug Administration imposes tighter restrictions on Mifeprex than on opioids such as fentanyl.
And all of this poses a burden on women and health care professionals — particularly those in rural and medically underserved areas.
So many women like S have to navigate FDA regulations imposed on Mifeprex and the ever-changing landscape of state abortion laws that target medication abortion. This can often be a source of anxiety because medication abortions are only available in the first 10 weeks of a pregnancy.
“I felt like nobody was going to be able to help me. I was just so, so scared of that happening,” S said.
Is it safe?
The abortion pill, developed in France in the 1980s, has a long and complicated history. The drug started changing abortion care around the world, except in the U.S., where approval of the pill was blocked by the violence and politics surrounding abortion. But in the 1990’s, Bill Clinton was elected president and politics helped make it available.
Dr. Beverly Winikoff worked for the Population Council, the organization that brought the abortion pill to the U.S., and remembers how revolutionary the drug was.
“A pill means you don't need a sterilization of a hypodermic needle. You don't need a surgeon, you don't need any kind of anesthesia,” said Dr. Winikoff, now president of Gynuity Health Projects.
Dr. Beverly Winikoff is now president of Gynuity Health Projects, a group researching the safety of sending Mifeprex by mail to patients. (Zach Cusson / Newsy)
In 2000, the FDA approved Mifeprex but it could not be sold at pharmacies with a prescription because the agency wanted to monitor its safety.
Today, a lot more is known about the safety of Mifeprex for medication abortion.
A database called the FDA Adverse Events Reporting System, or FAERS, tracks side effects, complications and even deaths after a person takes a drug.
The database shows that in the past 20 years about 3.7 million women in the U.S. have had a medication abortion and 24 women have died between September 28, 2000 and December 31, 2018, according to FDA records. In other words, for every one million patients, 6.5 died.
Dr. Donna Harrison, the executive director of the American Association of Pro-Life Obstetricians and Gynecologists, or AAPLOG, thinks that number is too low.
“These are women that were normal, healthy, pregnant and then they're dead,” Harrison said. “The complications can be very serious and sometimes they can kill women. And I think to say anything less is to be dishonest with women. “
Dr. Donna Harrison representing the American Association of Pro-Life Obstetricians and Gynecologists in front of an exhibit at the 2019 American College of Nurse Midwives annual meeting. (Zach Cusson / Newsy)
While some opponents of medication abortion say Mifeprex is dangerous and kills people, FDA data shows there is no direct link between taking the pill and the deaths. Nearly half of the recorded deaths appear to be related to homicide, drug abuse, suicide and emphysema.
“The problem is that it is a minimal number, so we have no way in this country of tracking the complications from Mifeprex abortions,” Harrison said.
Serious complications associated with having a medication abortion are rare. A 2018 report from the National Academies of Sciences, Engineering and Medicine, an independent organization, found “infection, hospitalizations and hemorrhage requiring transfusions occur in fewer than 1 percent of patients.”
Harrison doesn’t believe medication abortions should be an option to terminate pregnancies. But she said as long as they are, the FDA must do more to make the option safe.
“I would love to see the FDA actually do its job in monitoring the safety of this drug,” Harrison said. “I think the FDA has been deficient in its oversight of this drug post marketing.”
What the FDA has said about the safety of the drug Mifeprex can be confusing. (Andrew Lawler / Newsy)
The FDA acknowledges the FAERS database isn’t a perfect system, but it’s the one they use to help make decisions about all drugs. Reporting is voluntary for providers and patients, but mandatory for pharmaceutical companies. And over the years FDA enforcement of reporting has been an issue.
“It's extremely rare to have a bad outcome. More rare than with most other approved drugs,” Winikoff said.
She and others who support reproductive health rights have long questioned why these extreme restrictions persist. And with its proven safety record, why patients can’t get Mifeprex from a pharmacy.
“Exactly, what is more dangerous about picking a pill up in a pharmacy than having somebody giving it to you in a clinic and you take it home and you swallow it?” asked Winikoff.
Newsy analyzed the death rate of erectile dysfunction drugs because they are generally given to healthy people and deal with reproductive health, just like Mifeprex.
Data from one study shows erectile dysfunction drugs have a mortality rate about four times greater than Mifeprex. But unlike the abortion pill, erectile dysfunction drugs are sold at pharmacies with a prescription. Yet despite its own data, the FDA maintains Mifeprex is so risky it must be placed in a special program for its riskiest drugs called REMS, or Risk Evaluation and Mitigation Strategies.
Each REMS program is unique but there are some similarities. For example, Mifeprex isn’t the only drug in the U.S. you can’t get at a pharmacy — there are 14 of them. All have serious side effects that can happen immediately, including seizures, heart attacks and overdose. Which is why the FDA requires all of them to be administered by a doctor — except Mifeprex, which patients can take on their own.
The Food and Drug Administration headquarters in White Oak, Maryland. (Zach Cusson / Newsy)
FDA officials declined to speak to Newsy on camera. But, when asked why the drug still isn’t available at pharmacies, an agency spokesperson wrote in an email, “Certain restrictions continue to be necessary to ensure the safe use of the drug.”
Newsy reviewed numerous FDA documents. In a 2016 Mifeprex medical review, FDA officials repeatedly stated: “The safety profile of Mifeprex is well-characterized, that no new safety concerns have arisen in recent years, and that the known serious risks occur rarely.”
“There is a time when you can understand the regulatory agency is excessively cautious,” Winikoff said. “But it's 20 years on and three and a half million people later. And so now is the time to be realistic and say, ‘What are we doing?’ ”
Not being able to access the abortion pill at a pharmacy can be burdensome for women who live in rural communities, who are in medically underserved areas or who are financially disadvantaged. As well as health care providers caring for these patients.
In order for Dr. Graham Chelius to stock Mifeprex in his office, he first needs to get permission from his employer. This graphic illustrates all the entities he has to get permission from. (Andrew Lawler / Newsy)
The Mifeprex REMS program requires providers to stock the abortion pill in their office, which means in some cases they have to get permission from their employer.
“Unfortunately, because of the restrictions I don't provide medication abortions in my practice,” said Dr. Graham Chelius, a family physician. “I work for a health care system. And so I just can't say, you know, we're just going to stock this medicine.”
Dr. Graham Chelius drives Newsy reporters around the small island of Kauai. (Zach Cusson / Newsy)
Chelius lives on the rural Hawaiian island of Kauai. There are no abortion providers on the island, which means his patients have to take a plane to another island to get Mifeprex.
“For somebody who has a lot of resources, the Mifeprex REMs may not create an insurmountable barrier. For a lot of patients it does,” Chelius said. “It's so difficult and so complicated for them that they end up carrying a pregnancy to term.”
Which is why Chelius is part of a federal lawsuit to remove Mifeprex from the REMS program so his patients can get the drug from a pharmacy. The lawsuit is currently on hold.
Because the REMS program is controlled by the FDA it doesn’t matter if you live in a state like Hawaii, with no state abortion restrictions.
But the burden can be worse for women like S who live in states like Mississippi that have additional state restrictions on top of the FDA restriction.
There were other clinics in Louisiana and Alabama that were closer to where S and her husband lived, but they didn’t provide medication abortion. The Jackson Women’s Health Organization clinic was their last option.
“I went in for my ultrasound, she told me I was four to five weeks. So I caught it very, very early,” S said. ”Instantly it was like a weight was lifted off my shoulders because I was like ‘OK I can do a medical abortion’.”
S didn’t get her pills on that first visit because Mississippi has a 24-hour waiting period for all abortions.
“We could not afford it to be able to go immediately the next day either. Money was an issue and, you know, travel time. My husband had to take off work,” S said.
S was seven weeks pregnant by the time she made another three-hour drive to Jackson. At this appointment the doctor explained the side effects, then S swallowed the pill before going home. Twenty-four hours later, S took the second drug to complete the medication abortion.
“Some time during that night I definitely know when I passed the pregnancy,” S said.
In total, S drove nearly 14 hours and 780 miles over seven weeks to get the abortion pill.
“The FDA is there to protect the people who take drugs. The consumer. And, and they do a very good job,” Winikoff said. “But there's sometimes that you have to move back and say, ‘Wait. This may have been OK at the beginning but now it’s past its lifespan and we have to move on.’”
Reporters Rosie Cima and Stephanie Sandoval contributed to this story.
Angela M. Hill can be reached by email at email@example.com or on Twitter @AngelaMHill. Karen Rodriguez can be reached by email at firstname.lastname@example.org or on Twitter @krod65.
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