FDA: Make the Abortion Pill Available Over the Counter
The Issue
The FDA must eliminate the unjustified and unscientific barriers to abortion pill access as part of a federal effort to provide emergency relief in the wake of the Supreme Court's decision to revoke fundamental human rights from millions of Americans whose health, safety, and well-being have been instantly and gravely compromised as a result
The abortion pill (Plan C), a safe and effective way to end pregnancy through 11 weeks, is excessively regulated by the FDA. It must be made available to all Americans over the counter and without a prescription. Tell President Biden, FDA Commissioner Dr. Robert Califf, and Secretary of Health and Human Services Xavier Becerra that their oaths of office require them to take this step in order to save American lives and prevent incalculable suffering. This action does not require a supermajority in the Senate. This is an independent action that President Biden must undertake emergently to protect the lives and rights guaranteed to all Americans and to mitigate imminent and irreversible harm. The action taken by members of the Supreme Court to overturn Roe v. Wade violates the most basic human right, the right to bodily autonomy, the right not to be enslaved. The members of the Court who voted for it obtained their positions by deliberately misleading the public and lying to Congress under oath. Elected officials and their appointees who have sworn an oath to protect and defend the Constitution and the people of the United States should do so now or resign.
What is a Medication Abortion?
The most common medication abortion regimen in the United States can be used by anyone at home. It involves the use of two different medications: mifepristone and misoprostol. Mifepristone blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing. Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus, similar to an early miscarriage. Medication abortion is a safe and highly effective method of pregnancy termination. The pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).
Abortion with pills can also be done using only misoprostol pills. This is less effective than when mifepristone and misoprostol are both taken (about 85% of the abortions are successful). This is endorsed by the World Health Organization in places where mifepristone is not available. Both methods are effective and very safe. Both methods are also widely used by women around the world. Using abortion pills does not require the presence of a doctor. Some people find and take the medications on their own. This is called self-managed abortion. (see plancpills.org)
Almost 80% of American adults, including two-thirds of women, don’t know medication abortion exists, according to the Kaiser Family Foundation. But abortion pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce abortion.
Risk Evaluation and Mitigation Strategies (REMS)
Although the FDA approved mifepristone for use in 2000, in 2011 the FDA added a Risk Evaluation and Mitigation Strategy (REMS) to the dispensing requirements for mifepristone permitting only medical providers who had obtained certification from the manufacturer to prescribe and directly dispense the drug. This requirement not only limited the number of clinicians able to prescribe medication abortions, but also necessitated an in-person visit to a health care setting and meant patients could not obtain the medication from a retail pharmacy or by mail. In October 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserved areas. During the pandemic, ACOG and other provider groups filed a lawsuit challenging the REMS requirement that mifepristone be dispensed in person in response to the importance of having an alternative to the in-person requirement. On December 16, 2021, the FDA removed the in-person dispensing requirement for mifepristone and expanded the distribution to certified pharmacies in addition to certified clinicians. This change allows for distribution of medication abortion by mail in states that do not restrict telehealth for medication abortion. Despite the change to the in-person requirement, prescribers are still required to be certified by the manufacturers.
Mifepristone may be the least marketed pharmaceutical product in the U.S. There aren’t any ads for it on TV. Most doctors can’t prescribe it. Pharmacists don’t know much about it, since it doesn’t sit on the shelves at CVS or Walgreens. It would be reasonable to assume this is all because mifepristone is exceptionally dangerous, but it sends fewer people to the hospital than Tylenol. It’s also highly effective.
"Medication abortion really does meet all the FDA criteria for an over-the-counter switch," said Antonia Biggs, associate professor at the University of California, San Francisco's Obstetrics, Gynecology and Reproductive Sciences department. A study by Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label.
An over-the-counter designation would make it much easier to access abortion pills in states restricting their use and would protect the health and safety of countless people seeking reproductive care in this period of crisis. If the abortion pill can be purchased by anyone at a pharmacy without a prescription, it can be mailed from a friend or supporter in a state where they are not banned. This would be particularly useful for the almost 9 out of 10 American women who already live in counties without an abortion clinic.
Elisa Wells, who co-founded Plan C, a site that helps women get abortion pills, has seen firsthand how much easier things could be. While consulting on a research project in Ethiopia in 2014, she watched a colleague walk into a pharmacy with no prescription and leave 10 minutes later holding a packet with the abortion pill and instructions on how to use it. The box, bearing the name “Safe-T Kit,” was no bigger than a deck of cards and cost the equivalent of $7. “We’re standing there on the streets of this little town,” Wells says. “We looked at each other and said, ‘How is it available in Ethiopia, which is one of the most resource-poor countries in the world in respect to health care, but in the U.S. it’s restricted beyond reach?’ ”
IS IT SAFE?
FDA records show an extremely small mortality case number: As of June 2021, there were reports of 26 deaths associated with mifepristone out of 4.9 million people estimated to have taken the pill since the product was approved in September 2000.
The Abortion Pill Is Safer Than Tylenol:
The Lancet "Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study" (June 2022)
https://www.sciencedirect.com/science/article/pii/S2667193X22000175
https://www.aclu.org/letter/letter-fda-commissioner-jane-henney-restrictions-mifepristone
https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
When the U.S. Food and Drug Administration approved mifepristone 21 years ago, it was known as RU-486 and hailed as the most important advance in reproductive health since the birth control pill. Time magazine had called it “The Pill That Changes Everything.” It was supposed to provide an attractive alternative to surgical procedures, which can involve sedation, a visit to a health-care facility, and obviously a great deal of medical expertise. At the time, the abortion battleground was, by and large, women’s health clinics. The pill, in theory, could allow women to bypass clinics, and throngs of protesters, almost entirely.
Yet in the two decades since FDA approval, mifepristone has failed to reach liftoff. If anything, it’s receded from view. A labyrinth of regulatory restrictions has kept it intentionally out of reach. Most abortions in the U.S. are still done by surgical procedure, even though the majority of people ending their pregnancy do so early enough to take the pill instead.
For years, activists, health-care professionals, and medical researchers have been building a case that the abortion pill should be treated like other medications that come with similarly few medical concerns. With the U.S. entering a new era of restricted abortion access, the cause is more urgent than ever.
The FDA last year reviewed its restrictions on mifepristone, but ultimately decided to keep all but one in place. Women no longer have to pick up the pill at a doctor’s office. But the FDA left all of the other idiosyncratic hoops in place. Plus the agency added another: Pharmacies have to get certified to distribute the drug—a rule that only applies to 40 FDA-approved drugs, out of more than 19,000.
In 1988, France became the first Western country to approve the pill for abortions. Within a month, anti-abortion protesters successfully pressured Roussel Uclaf to halt its distribution. The French health minister, Claude Évin, intervened and put it back on the market. “I could not permit the abortion debate to deprive women of a product that represents medical progress,” he said at the time. “From the moment government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company.”
Over the past two decades, researchers and medical bodies have built a growing and compelling case that the regulations are medically unnecessary.
A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized. The study’s authors concluded that abortion by pill is “highly effective and safe.”
Jane Henney, who was leading the FDA at the time of mifepristone’s approval, came out in 2019 to argue against the REMS in a New England Journal of Medicine opinion piece that she co-wrote. Nearly two decades of use and additional research “clearly demonstrate that mifepristone is extremely safe and effective,” the authors wrote. “We believe that the distribution restrictions may no longer be appropriate.”
Yet even in the face of this data, regulatory oversight hasn’t meaningfully changed. The FDA told Bloomberg Businessweek that after conducting a comprehensive review of published literature and data provided to the agency, it concluded that it was safe to remove the in-person dispensing requirement, “provided all the other requirements of the REMS are met, and pharmacy certification is added.”
“They reinforced the misconception that the pills are somehow dangerous and need this layer of protection, which they don’t,” says Elisa Wells, who co-founded Plan C, a site that helps women get abortion pills. “It’s just a real disappointment that after 20 years’ worth of data that we have about the safety of the pills that the FDA didn’t remove all the restrictions and allow the pills to be available the way that so many other drugs are: through pharmacies without any special requirements.”
In 2017 the American Civil Liberties Union filed a lawsuit against the FDA to get the agency to remove the laundry list of obligations that come with prescribing or receiving mifepristone. The case argues that the government’s rules place an undue burden on a patient’s right to an abortion and violate the right to privacy under the Fifth Amendment. “There is no reason why these restrictions should or have improved the safety of abortions,” he says. “For certain, women have been harmed by these restrictions.”
“We urge the FDA to further eliminate unjustified and unscientific barriers to care,” says Julia Kaye, the lead ACLU attorney on the case.
Making mifepristone available over the counter without a prescription would make abortions much easier to get, particularly for people who live far from clinics. The farther a woman lives from a clinic, the more likely she is to seek out mifepristone—even with the FDA’s hurdles. A 2021 study looking at about 57,000 abortions in almost 80% of the country’s counties showed that a 47-mile increase in distance to the nearest clinic was associated with a 41% increase in the use of telemedicine and medication abortion.
Conservative lawmakers know the power of this pill: Prior to the decision to overturn Roe, nineteen states had already banned using telemedicine to get a prescription for the abortion pill by requiring a clinician to be physically present when the drug is being given, according to the Guttmacher Institute, a reproductive rights research group. And more mifepristone-specific laws keep coming. A new Texas law threatens anyone who prescribes the abortion pill through telehealth and mails it with jail time and a fine of up to $10,000. Many other states are fast following suit.
In a post-Roe world, legal abortion will all but disappear in almost half of the states unless there’s a way to get mifepristone into those places. That raises a question University of Pittsburgh School of Law assistant professor Greer Donley is exploring right now: Can states ban the shipment of mifepristone if the FDA explicitly says it’s allowed?
A Massachusetts case may provide some answers. When the FDA approved the powerful, long-acting opioid Zohydro in 2013, the governor tried to ban the sale of the drug in his state. The drug’s maker sued, and a U.S. district judge ruled that the state did not have the authority to overstep the FDA. Donley thinks this could provide the framework for a legal argument against state bans on mail-order abortion pills. If it works, it could also mean the pill remains available in places that ban abortion altogether. “This idea that the states can’t do something that frustrates the purpose of federal law, that’s the strongest way to go at mifepristone,” Donley says. There’s no guarantee it’ll work, but she thinks it’s worth a shot.
“The anti-abortion movement has been trying these pretty outlandish strategies on so many different fronts for decades, and a lot of times they fail, but sometimes they don’t. And now we are where we are,” she says. “It’s time to get creative.”
The future of medication abortion in a post-Roe world
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1393 (Published 02 June 2022)
https://www.bmj.com/content/377/bmj.o1393
UCSF: Medication abortions without ultrasound are safe and effective a new study finds (June, 2022)
Journal of the American Medical Association: (3/2022)
Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790319
New England Journal of Medicine (2016):
Sixteen Years of Overregulation: Time to Unburden Mifeprex
This Sounding Board article argues against the need for the currently required Risk Evaluation and Mitigation Strategy (REMS) for the drug Mifeprex for abortion, given the very low rate of adverse events associated with its use.
New England Journal of Medicine; 2017 Feb 23; 376(8): 790-794; doi:10.1056/NEJMsb1612526
FDA Protocol
The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1). Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone.
FDA Mifepristone and Misoprostol Regimen to Induce Abortion:
Mifepristone dosage
200mg (one pill), taken orally
Misoprostol dosage
800µg (4 pills), taken buccally (placed in cheek) or vaginally
Misoprostol timing
24-48 hours after mifepristone buccally, or 6-72 hours after mifepristone vaginally
Source: FDA, Mifeprex (mifepristone) Information, February 2018
2,392
The Issue
The FDA must eliminate the unjustified and unscientific barriers to abortion pill access as part of a federal effort to provide emergency relief in the wake of the Supreme Court's decision to revoke fundamental human rights from millions of Americans whose health, safety, and well-being have been instantly and gravely compromised as a result
The abortion pill (Plan C), a safe and effective way to end pregnancy through 11 weeks, is excessively regulated by the FDA. It must be made available to all Americans over the counter and without a prescription. Tell President Biden, FDA Commissioner Dr. Robert Califf, and Secretary of Health and Human Services Xavier Becerra that their oaths of office require them to take this step in order to save American lives and prevent incalculable suffering. This action does not require a supermajority in the Senate. This is an independent action that President Biden must undertake emergently to protect the lives and rights guaranteed to all Americans and to mitigate imminent and irreversible harm. The action taken by members of the Supreme Court to overturn Roe v. Wade violates the most basic human right, the right to bodily autonomy, the right not to be enslaved. The members of the Court who voted for it obtained their positions by deliberately misleading the public and lying to Congress under oath. Elected officials and their appointees who have sworn an oath to protect and defend the Constitution and the people of the United States should do so now or resign.
What is a Medication Abortion?
The most common medication abortion regimen in the United States can be used by anyone at home. It involves the use of two different medications: mifepristone and misoprostol. Mifepristone blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing. Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus, similar to an early miscarriage. Medication abortion is a safe and highly effective method of pregnancy termination. The pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).
Abortion with pills can also be done using only misoprostol pills. This is less effective than when mifepristone and misoprostol are both taken (about 85% of the abortions are successful). This is endorsed by the World Health Organization in places where mifepristone is not available. Both methods are effective and very safe. Both methods are also widely used by women around the world. Using abortion pills does not require the presence of a doctor. Some people find and take the medications on their own. This is called self-managed abortion. (see plancpills.org)
Almost 80% of American adults, including two-thirds of women, don’t know medication abortion exists, according to the Kaiser Family Foundation. But abortion pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce abortion.
Risk Evaluation and Mitigation Strategies (REMS)
Although the FDA approved mifepristone for use in 2000, in 2011 the FDA added a Risk Evaluation and Mitigation Strategy (REMS) to the dispensing requirements for mifepristone permitting only medical providers who had obtained certification from the manufacturer to prescribe and directly dispense the drug. This requirement not only limited the number of clinicians able to prescribe medication abortions, but also necessitated an in-person visit to a health care setting and meant patients could not obtain the medication from a retail pharmacy or by mail. In October 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserved areas. During the pandemic, ACOG and other provider groups filed a lawsuit challenging the REMS requirement that mifepristone be dispensed in person in response to the importance of having an alternative to the in-person requirement. On December 16, 2021, the FDA removed the in-person dispensing requirement for mifepristone and expanded the distribution to certified pharmacies in addition to certified clinicians. This change allows for distribution of medication abortion by mail in states that do not restrict telehealth for medication abortion. Despite the change to the in-person requirement, prescribers are still required to be certified by the manufacturers.
Mifepristone may be the least marketed pharmaceutical product in the U.S. There aren’t any ads for it on TV. Most doctors can’t prescribe it. Pharmacists don’t know much about it, since it doesn’t sit on the shelves at CVS or Walgreens. It would be reasonable to assume this is all because mifepristone is exceptionally dangerous, but it sends fewer people to the hospital than Tylenol. It’s also highly effective.
"Medication abortion really does meet all the FDA criteria for an over-the-counter switch," said Antonia Biggs, associate professor at the University of California, San Francisco's Obstetrics, Gynecology and Reproductive Sciences department. A study by Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label.
An over-the-counter designation would make it much easier to access abortion pills in states restricting their use and would protect the health and safety of countless people seeking reproductive care in this period of crisis. If the abortion pill can be purchased by anyone at a pharmacy without a prescription, it can be mailed from a friend or supporter in a state where they are not banned. This would be particularly useful for the almost 9 out of 10 American women who already live in counties without an abortion clinic.
Elisa Wells, who co-founded Plan C, a site that helps women get abortion pills, has seen firsthand how much easier things could be. While consulting on a research project in Ethiopia in 2014, she watched a colleague walk into a pharmacy with no prescription and leave 10 minutes later holding a packet with the abortion pill and instructions on how to use it. The box, bearing the name “Safe-T Kit,” was no bigger than a deck of cards and cost the equivalent of $7. “We’re standing there on the streets of this little town,” Wells says. “We looked at each other and said, ‘How is it available in Ethiopia, which is one of the most resource-poor countries in the world in respect to health care, but in the U.S. it’s restricted beyond reach?’ ”
IS IT SAFE?
FDA records show an extremely small mortality case number: As of June 2021, there were reports of 26 deaths associated with mifepristone out of 4.9 million people estimated to have taken the pill since the product was approved in September 2000.
The Abortion Pill Is Safer Than Tylenol:
The Lancet "Safety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study" (June 2022)
https://www.sciencedirect.com/science/article/pii/S2667193X22000175
https://www.aclu.org/letter/letter-fda-commissioner-jane-henney-restrictions-mifepristone
https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
When the U.S. Food and Drug Administration approved mifepristone 21 years ago, it was known as RU-486 and hailed as the most important advance in reproductive health since the birth control pill. Time magazine had called it “The Pill That Changes Everything.” It was supposed to provide an attractive alternative to surgical procedures, which can involve sedation, a visit to a health-care facility, and obviously a great deal of medical expertise. At the time, the abortion battleground was, by and large, women’s health clinics. The pill, in theory, could allow women to bypass clinics, and throngs of protesters, almost entirely.
Yet in the two decades since FDA approval, mifepristone has failed to reach liftoff. If anything, it’s receded from view. A labyrinth of regulatory restrictions has kept it intentionally out of reach. Most abortions in the U.S. are still done by surgical procedure, even though the majority of people ending their pregnancy do so early enough to take the pill instead.
For years, activists, health-care professionals, and medical researchers have been building a case that the abortion pill should be treated like other medications that come with similarly few medical concerns. With the U.S. entering a new era of restricted abortion access, the cause is more urgent than ever.
The FDA last year reviewed its restrictions on mifepristone, but ultimately decided to keep all but one in place. Women no longer have to pick up the pill at a doctor’s office. But the FDA left all of the other idiosyncratic hoops in place. Plus the agency added another: Pharmacies have to get certified to distribute the drug—a rule that only applies to 40 FDA-approved drugs, out of more than 19,000.
In 1988, France became the first Western country to approve the pill for abortions. Within a month, anti-abortion protesters successfully pressured Roussel Uclaf to halt its distribution. The French health minister, Claude Évin, intervened and put it back on the market. “I could not permit the abortion debate to deprive women of a product that represents medical progress,” he said at the time. “From the moment government approval for the drug was granted, RU-486 became the moral property of women, not just the property of a drug company.”
Over the past two decades, researchers and medical bodies have built a growing and compelling case that the regulations are medically unnecessary.
A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized. The study’s authors concluded that abortion by pill is “highly effective and safe.”
Jane Henney, who was leading the FDA at the time of mifepristone’s approval, came out in 2019 to argue against the REMS in a New England Journal of Medicine opinion piece that she co-wrote. Nearly two decades of use and additional research “clearly demonstrate that mifepristone is extremely safe and effective,” the authors wrote. “We believe that the distribution restrictions may no longer be appropriate.”
Yet even in the face of this data, regulatory oversight hasn’t meaningfully changed. The FDA told Bloomberg Businessweek that after conducting a comprehensive review of published literature and data provided to the agency, it concluded that it was safe to remove the in-person dispensing requirement, “provided all the other requirements of the REMS are met, and pharmacy certification is added.”
“They reinforced the misconception that the pills are somehow dangerous and need this layer of protection, which they don’t,” says Elisa Wells, who co-founded Plan C, a site that helps women get abortion pills. “It’s just a real disappointment that after 20 years’ worth of data that we have about the safety of the pills that the FDA didn’t remove all the restrictions and allow the pills to be available the way that so many other drugs are: through pharmacies without any special requirements.”
In 2017 the American Civil Liberties Union filed a lawsuit against the FDA to get the agency to remove the laundry list of obligations that come with prescribing or receiving mifepristone. The case argues that the government’s rules place an undue burden on a patient’s right to an abortion and violate the right to privacy under the Fifth Amendment. “There is no reason why these restrictions should or have improved the safety of abortions,” he says. “For certain, women have been harmed by these restrictions.”
“We urge the FDA to further eliminate unjustified and unscientific barriers to care,” says Julia Kaye, the lead ACLU attorney on the case.
Making mifepristone available over the counter without a prescription would make abortions much easier to get, particularly for people who live far from clinics. The farther a woman lives from a clinic, the more likely she is to seek out mifepristone—even with the FDA’s hurdles. A 2021 study looking at about 57,000 abortions in almost 80% of the country’s counties showed that a 47-mile increase in distance to the nearest clinic was associated with a 41% increase in the use of telemedicine and medication abortion.
Conservative lawmakers know the power of this pill: Prior to the decision to overturn Roe, nineteen states had already banned using telemedicine to get a prescription for the abortion pill by requiring a clinician to be physically present when the drug is being given, according to the Guttmacher Institute, a reproductive rights research group. And more mifepristone-specific laws keep coming. A new Texas law threatens anyone who prescribes the abortion pill through telehealth and mails it with jail time and a fine of up to $10,000. Many other states are fast following suit.
In a post-Roe world, legal abortion will all but disappear in almost half of the states unless there’s a way to get mifepristone into those places. That raises a question University of Pittsburgh School of Law assistant professor Greer Donley is exploring right now: Can states ban the shipment of mifepristone if the FDA explicitly says it’s allowed?
A Massachusetts case may provide some answers. When the FDA approved the powerful, long-acting opioid Zohydro in 2013, the governor tried to ban the sale of the drug in his state. The drug’s maker sued, and a U.S. district judge ruled that the state did not have the authority to overstep the FDA. Donley thinks this could provide the framework for a legal argument against state bans on mail-order abortion pills. If it works, it could also mean the pill remains available in places that ban abortion altogether. “This idea that the states can’t do something that frustrates the purpose of federal law, that’s the strongest way to go at mifepristone,” Donley says. There’s no guarantee it’ll work, but she thinks it’s worth a shot.
“The anti-abortion movement has been trying these pretty outlandish strategies on so many different fronts for decades, and a lot of times they fail, but sometimes they don’t. And now we are where we are,” she says. “It’s time to get creative.”
The future of medication abortion in a post-Roe world
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1393 (Published 02 June 2022)
https://www.bmj.com/content/377/bmj.o1393
UCSF: Medication abortions without ultrasound are safe and effective a new study finds (June, 2022)
Journal of the American Medical Association: (3/2022)
Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790319
New England Journal of Medicine (2016):
Sixteen Years of Overregulation: Time to Unburden Mifeprex
This Sounding Board article argues against the need for the currently required Risk Evaluation and Mitigation Strategy (REMS) for the drug Mifeprex for abortion, given the very low rate of adverse events associated with its use.
New England Journal of Medicine; 2017 Feb 23; 376(8): 790-794; doi:10.1056/NEJMsb1612526
FDA Protocol
The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1). Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone.
FDA Mifepristone and Misoprostol Regimen to Induce Abortion:
Mifepristone dosage
200mg (one pill), taken orally
Misoprostol dosage
800µg (4 pills), taken buccally (placed in cheek) or vaginally
Misoprostol timing
24-48 hours after mifepristone buccally, or 6-72 hours after mifepristone vaginally
Source: FDA, Mifeprex (mifepristone) Information, February 2018
2,392
The Decision Makers
Petition created on June 24, 2022