In response to the FDA’s decision today, which permanently lifted a restriction that required patients to pick up medication abortion in-person at a medical facility, Anna Bernstein, a health care expert and fellow at The Century Foundation, who wrote a seminal report, “Medication Abortion Care Is Safe and Effective—It’s Time Everyone Has Equal Access,” issued the following statement:
“Amid the attacks on reproductive rights taking hold across the country, and the likely decision by the Supreme Court next year to overturn Roe, which would effectively ban abortion in 26 states, the need for universal, affordable access to medication abortion has never been greater. Today’s decision by the FDA to allow patients to obtain mifepristone, a drug used for early abortion care, by mail or by picking it up from a pharmacy like CVS—both of which were previously not allowed—is an enormous step forward for reproductive rights and justice. The FDA has taken a scientifically-sound step that will allow millions of women across the country to now have access to safe, effective medication abortion care that was previously out of reach for them.
“The science could not be clearer: mifepristone and medication abortion is overwhelmingly safe and effective—and the FDA’s overly burdensome restrictions on the use of pills to terminate pregnancy are both medically unnecessary and disproportionately harm Black, low-income women and people living in rural areas. COVID-19 has only reinforced the safety and popularity of mifepristone, which accounted for 42 percent of all abortions in 2019. Clinical outcomes during the pandemic demonstrated high rates of abortions completed without the need for a procedure (95 percent), with very few adverse outcomes. This is in line with earlier evidence showing that adverse effects occur in less than 0.3 percent of medication abortions in the U.S., making it safer than common medications like Tylenol.
“The pandemic offered a natural experiment to test whether the telehealth provision of medication abortion could be done effectively, on a large scale, with few restrictions. The answer was an unequivocal ‘yes.’ Today’s decision is a win for pregnant people across the nation, but it should not be overlooked that the FDA failed to remove all the current restrictions on the administration of mifepristone. The continuation of the remaining REMS restrictions—forcing providers to pre-register with the mifepristone manufacturer in order to prescribe the time-sensitive medicine, and requiring patients to sign a duplicative form that singles them out—will keep mifepristone from being as accessible as it could and should be.
“Bigger picture, Congress must pass the Women’s Health Protection Act (WHPA), which would create a right to abortion for both patients and providers so that states cannot pass restrictions on abortion that have no basis in medicine. It’s the only way to truly ensure that women and birthing people, not politicians, have the freedom to control their own health and bodies.”
For more background on mifepristone, medication abortion, and its provision via telemedicine, see Anna’s report: “Medication Abortion Care Is Safe and Effective—It’s Time Everyone Has Equal Access.” In addition to thoroughly examining the evidence on medication abortion, the study features first-person interviews (and select audio clips) with abortion providers and patients, as well as recommendations to increase equity in medication abortion care.
For additional background, see Anna’s recent piece: “5 Things to Know about Abortion Access as Supreme Court Hears Dobbs v. JWHO.”
Tags: abortion access, abortion rights, medication abortion, mifepristone
TCF Fellow Anna Bernstein Hails FDA’s Decision to Strip In-person Restrictions on Mifepristone, a Medication Abortion Pill
In response to the FDA’s decision today, which permanently lifted a restriction that required patients to pick up medication abortion in-person at a medical facility, Anna Bernstein, a health care expert and fellow at The Century Foundation, who wrote a seminal report, “Medication Abortion Care Is Safe and Effective—It’s Time Everyone Has Equal Access,” issued the following statement:
“Amid the attacks on reproductive rights taking hold across the country, and the likely decision by the Supreme Court next year to overturn Roe, which would effectively ban abortion in 26 states, the need for universal, affordable access to medication abortion has never been greater. Today’s decision by the FDA to allow patients to obtain mifepristone, a drug used for early abortion care, by mail or by picking it up from a pharmacy like CVS—both of which were previously not allowed—is an enormous step forward for reproductive rights and justice. The FDA has taken a scientifically-sound step that will allow millions of women across the country to now have access to safe, effective medication abortion care that was previously out of reach for them.
“The science could not be clearer: mifepristone and medication abortion is overwhelmingly safe and effective—and the FDA’s overly burdensome restrictions on the use of pills to terminate pregnancy are both medically unnecessary and disproportionately harm Black, low-income women and people living in rural areas. COVID-19 has only reinforced the safety and popularity of mifepristone, which accounted for 42 percent of all abortions in 2019. Clinical outcomes during the pandemic demonstrated high rates of abortions completed without the need for a procedure (95 percent), with very few adverse outcomes. This is in line with earlier evidence showing that adverse effects occur in less than 0.3 percent of medication abortions in the U.S., making it safer than common medications like Tylenol.
“The pandemic offered a natural experiment to test whether the telehealth provision of medication abortion could be done effectively, on a large scale, with few restrictions. The answer was an unequivocal ‘yes.’ Today’s decision is a win for pregnant people across the nation, but it should not be overlooked that the FDA failed to remove all the current restrictions on the administration of mifepristone. The continuation of the remaining REMS restrictions—forcing providers to pre-register with the mifepristone manufacturer in order to prescribe the time-sensitive medicine, and requiring patients to sign a duplicative form that singles them out—will keep mifepristone from being as accessible as it could and should be.
“Bigger picture, Congress must pass the Women’s Health Protection Act (WHPA), which would create a right to abortion for both patients and providers so that states cannot pass restrictions on abortion that have no basis in medicine. It’s the only way to truly ensure that women and birthing people, not politicians, have the freedom to control their own health and bodies.”
For more background on mifepristone, medication abortion, and its provision via telemedicine, see Anna’s report: “Medication Abortion Care Is Safe and Effective—It’s Time Everyone Has Equal Access.” In addition to thoroughly examining the evidence on medication abortion, the study features first-person interviews (and select audio clips) with abortion providers and patients, as well as recommendations to increase equity in medication abortion care.
For additional background, see Anna’s recent piece: “5 Things to Know about Abortion Access as Supreme Court Hears Dobbs v. JWHO.”
Tags: abortion access, abortion rights, medication abortion, mifepristone