Columnist Carrie Baker: Abortion pills are safe and should be more accessible, not less

By CARRIE BAKER

Published: 04-26-2023 10:28 PM

The medication mifepristone is a convenient and private way to end an early pregnancy, which is why abortion opponents are trying to remove it from the market with false claims about its safety. Extensive research has proved mifepristone is very safe, but anti-abortion politics have kept this medication highly restricted since the FDA approved it in 2000. If it were any other medication, mifepristone would be available over the counter.

Mifepristone blocks progesterone, which sustains a pregnancy, and is taken in combination with a second medication called misoprostol, which causes the uterus to contract and expel a pregnancy.

On April 7, a Trump-appointed federal judge Matthew Kacsmaryk of the Northern District of Texas tried to stay the FDA’s approval of mifepristone. On April 12, the Fifth Circuit appeals court reversedKacsmaryk’s ruling in part, but tried to re-impose burdensome restrictions on mifepristone that were in place before 2016. These restrictions included allowing only doctors to prescribe the medication, allowing mifepristone only in the first seven weeks of pregnancy (versus 10 weeks) and requiring multiple in-person appointments, thus not allowing telemedicine abortion. The Fifth Circuit also would have reversed the FDA’s 2016 decision to adjust the recommended dosage based on studies showing a lower dosage of mifepristone was just as effective and had fewer side effects. Finally, the Fifth Circuit would have reversed the FDA’s approval of a generic mifepristone in 2019. The Supreme Court stayed the Fifth Circuit’s decision on April 21.

The lower courts gave two reasons for trying to restrict mifepristone. First, the Texas judge ruled the FDA had rushed the approval of mifepristone in 2000. In fact, anti-abortion political interference delayed FDA approval for 12 years. The FDA’s review of the drugmaker’s application for approval of mifepristone took over three times longer than for other drugs at the time: 54 months to approve mifepristone, compared to an average wait time of 15 months for approval of other medications at the time.

The lower courts gave two reasons for trying to restrict mifepristone. First, the Texas judge ruled the FDA had rushed the approval of mifepristone in 2000. In fact, anti-abortion political interference delayed FDA approval for 12 years. The FDA’s review of the drugmaker’s application for approval of mifepristone took over three times longer than for other drugs at the time: 54 months to approve mifepristone, compared to an average wait time of 15 months for approval of other medications at the time.

Second, the Texas judge and the Fifth Circuit judges ruled mifepristone was not safe for pregnant women. However, over 100 scientific studies have proven mifepristone to be a safe method for ending a pregnancy.According to a brief filed with the Fifth Circuit by leading medical and public health organizations, including the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association, “the scientific evidence supporting mifepristone’s safety and efficacy is overwhelming. Mifepristone is one of the most studied medications prescribed in the United States and has a safety profile comparable to ibuprofen.”

The Supreme Court has sent the case back to the Fifth Circuit, where oral arguments are scheduled for May 17. A lot is at stake in this case. Should the Fifth Circuit’s previous ruling go into effect, access to mifepristone will decrease significantly across the country, even in states like Massachusetts. Such a ruling would end telemedicine abortion with mifepristone, which has expanded significantly since the FDA finally allowed it in 2021. Women and pregnant people would have to travel long distances to find certified doctors, who are far and few between. They would have to make multiple visits over several days to obtain abortion pills. And doctors could only prescribe the medication in the first seven weeks of pregnancy (49 days) — which means just five weeks after conception, since pregnancy is dated from the first day of the last menstrual period. Doctors would have to prescribe a higher dosage, which would cause more side effects.

Leading medical associations, including ACOG and the AMA, contend that the FDA has overregulated mifepristone by requiring those dispensing the medication to be certified with the drug manufacturer, thereby limiting access to the drug. There are now lawsuits in Washington and Maryland challenging these FDA restrictions. There are also lawsuits in North Carolina and West Virginia arguing additional state restrictions on mifepristone, such as bans, waiting periods and in-person dispensing requirements, are preempted by federal law. Courts should follow the science and remove all of these restrictions. But even that is not enough. To truly follow the science, abortion pills should be available over the counter, on the pharmacy shelf next to menstrual products and condoms.

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No matter what happens with the law, abortion pills aren’t going away. Post-Roe, as states prohibit health care workers from offering abortion services, reproductive health advocates have developed robust alternative supply systems for abortion pills in the U.S. and an ecosystem of support, including free hotlines and community networks (see www.plancpills.org for details). But we shouldn’t have to do this. Abortion pills should be legal, widely available and affordable, and people using them should be treated with dignity and respect.

Carrie N. Baker is a professor in the Program for the Study of Women and Gender at Smith College and a regular contributor to Ms. Magazine.]]>