US regulators lift in-person restrictions on abortion pill
By MATTHEW PERRONE
This Sept. 22, 2010 file photo shows bottles of abortion pills at a clinic in Des Moines, Iowa. The Food and Drug Administration on Thursday, Dec. 16, 2021 loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies. (AP Photo/Charlie Neibergall, file)
WASHINGTON (AP) — The Food and Drug Administration on Thursday permanently removed a major obstacle for women seeking abortion pills, eliminating a long-standing requirement that they pick up the medication in person.
Millions of American women will now be able to get a prescription via an online consultation and receive the pills through the mail. FDA officials said a scientific review supported broadening access, including no longer limiting dispensing to a small number of specialty clinics and doctor’s offices.
But prescribers will still need to undergo certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
The decision is the latest shift in the polarized legal battle over medication abortion, which has only intensified amid the disruptions of the COVID-19 pandemic. It is certain to spur legal challenges and more restrictions in Republican-led states.
Earlier this year the FDA stopped enforcing the in-person requirement because of the pandemic. Under Thursday’s decision, the agency permanently dropped the 20-year-old rule, which has long been opposed by medical societies, including the American Medical Association, which say the restriction offers no clear benefit to patients.
The FDA’s latest scientific review stems from a 2017 lawsuit led by the American Civil Liberties Union, which argued that the agency’s restrictions block or delay medical care, especially for people in low-income and rural communities.
The ACLU hailed the elimination of the strictest requirements but said regulators should have gone further and allowed prescribing by any physician and broader pharmacy dispensing. Abortion opponents said the FDA decision would result in more drug-related side effects and complications for women.
Physicians who prescribe the drug, mifepristone, will have to certify that they can provide emergency care to deal with potential adverse effects, including excessive bleeding, FDA officials said Thursday.
The change still means many more doctors will be able to write prescriptions and American women will be able to fill their orders at far more pharmacies, including via online and mail-order services.
The effect will vary by state. More than a dozen Republican-led states have passed measures that limit access to the pills, including outlawing delivery by mail.
Increased use of mail-order abortion pills could pose a dilemma for the anti-abortion movement, given that its leaders generally say they don’t favor criminalizing the actions of women seeking abortions and because mail deliveries can be an elusive target for prosecutors.
The latest policy shift comes as advocates on both sides of the abortion debate wait to see whether the conservative Supreme Court will weaken or even overturn the Roe v. Wade decision that guarantees the right to abortion nationwide.
Roe’s demise would likely prompt at least 20 Republican-governed states to impose sweeping bans while perhaps 15 states governed by Democrats would reaffirm support for abortion access. More complicated would be politically divided states, where fights over abortion laws could be ferocious.
Medication abortion has been available in the United States since 2000, when the FDA first approved mifepristone to terminate pregnancies up to 10 weeks. Taken with another drug called misoprostol, it constitutes the so-called abortion pill.
About 40% of all abortions in the U.S. are now done through medication — rather than surgery — and that option has become more pivotal during the COVID-19 pandemic.
At the time of approval, the FDA imposed limits on how the drug could be distributed, including barring it from regular pharmacies and requiring that all doctors providing the drug undergo special certification. Women were also required to sign a form indicating they understood the medication’s risks. The FDA said Thursday there have been 26 deaths associated with the drug since 2000, though not all of those can be directly attributed to the medication due to underlying health conditions and other factors.
Common drug side effects include cramping, bleeding, nausea, headache and diarrhea. In some cases excess bleeding needs to be stopped with a surgical procedure.
Near the beginning of the outbreak, the FDA waived in-person requirements for virtually all medications, but left them in place for mifepristone.
That triggered a lawsuit from the American College of Obstetricians and Gynecologists, which successfully overturned the restriction in federal court. The Trump administration then appealed the ruling to the Supreme Court, which reinstated the requirement in January.
The point became moot — at least temporarily — in April when the FDA said it would not enforce the dispensing limits during the current public health emergency.
“The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients,” said Georgeanne Usova, a lawyer with the ACLU. “However, it is disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone and these remaining obstacles should also be lifted.”
Jeanne Mancini, president of the March for Life Education and Defense Fund, said the decision “will lead to more lives lost to abortion, and will increase the number of mothers who suffer physical and psychological harm from chemical abortions.”
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Associated Press writer David Crary contributed to this story from New York.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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This story was first published on December 16, 2021. It was updated on February 24, 2022 to delete an incorrect description of the drug misoprostol as a hormone blocker.
By MATTHEW PERRONE
This Sept. 22, 2010 file photo shows bottles of abortion pills at a clinic in Des Moines, Iowa. The Food and Drug Administration on Thursday, Dec. 16, 2021 loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies. (AP Photo/Charlie Neibergall, file)
WASHINGTON (AP) — The Food and Drug Administration on Thursday permanently removed a major obstacle for women seeking abortion pills, eliminating a long-standing requirement that they pick up the medication in person.
Millions of American women will now be able to get a prescription via an online consultation and receive the pills through the mail. FDA officials said a scientific review supported broadening access, including no longer limiting dispensing to a small number of specialty clinics and doctor’s offices.
But prescribers will still need to undergo certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
The decision is the latest shift in the polarized legal battle over medication abortion, which has only intensified amid the disruptions of the COVID-19 pandemic. It is certain to spur legal challenges and more restrictions in Republican-led states.
Earlier this year the FDA stopped enforcing the in-person requirement because of the pandemic. Under Thursday’s decision, the agency permanently dropped the 20-year-old rule, which has long been opposed by medical societies, including the American Medical Association, which say the restriction offers no clear benefit to patients.
The FDA’s latest scientific review stems from a 2017 lawsuit led by the American Civil Liberties Union, which argued that the agency’s restrictions block or delay medical care, especially for people in low-income and rural communities.
The ACLU hailed the elimination of the strictest requirements but said regulators should have gone further and allowed prescribing by any physician and broader pharmacy dispensing. Abortion opponents said the FDA decision would result in more drug-related side effects and complications for women.
Physicians who prescribe the drug, mifepristone, will have to certify that they can provide emergency care to deal with potential adverse effects, including excessive bleeding, FDA officials said Thursday.
The change still means many more doctors will be able to write prescriptions and American women will be able to fill their orders at far more pharmacies, including via online and mail-order services.
The effect will vary by state. More than a dozen Republican-led states have passed measures that limit access to the pills, including outlawing delivery by mail.
Increased use of mail-order abortion pills could pose a dilemma for the anti-abortion movement, given that its leaders generally say they don’t favor criminalizing the actions of women seeking abortions and because mail deliveries can be an elusive target for prosecutors.
The latest policy shift comes as advocates on both sides of the abortion debate wait to see whether the conservative Supreme Court will weaken or even overturn the Roe v. Wade decision that guarantees the right to abortion nationwide.
Roe’s demise would likely prompt at least 20 Republican-governed states to impose sweeping bans while perhaps 15 states governed by Democrats would reaffirm support for abortion access. More complicated would be politically divided states, where fights over abortion laws could be ferocious.
Medication abortion has been available in the United States since 2000, when the FDA first approved mifepristone to terminate pregnancies up to 10 weeks. Taken with another drug called misoprostol, it constitutes the so-called abortion pill.
About 40% of all abortions in the U.S. are now done through medication — rather than surgery — and that option has become more pivotal during the COVID-19 pandemic.
At the time of approval, the FDA imposed limits on how the drug could be distributed, including barring it from regular pharmacies and requiring that all doctors providing the drug undergo special certification. Women were also required to sign a form indicating they understood the medication’s risks. The FDA said Thursday there have been 26 deaths associated with the drug since 2000, though not all of those can be directly attributed to the medication due to underlying health conditions and other factors.
Common drug side effects include cramping, bleeding, nausea, headache and diarrhea. In some cases excess bleeding needs to be stopped with a surgical procedure.
Near the beginning of the outbreak, the FDA waived in-person requirements for virtually all medications, but left them in place for mifepristone.
That triggered a lawsuit from the American College of Obstetricians and Gynecologists, which successfully overturned the restriction in federal court. The Trump administration then appealed the ruling to the Supreme Court, which reinstated the requirement in January.
The point became moot — at least temporarily — in April when the FDA said it would not enforce the dispensing limits during the current public health emergency.
“The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients,” said Georgeanne Usova, a lawyer with the ACLU. “However, it is disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone and these remaining obstacles should also be lifted.”
Jeanne Mancini, president of the March for Life Education and Defense Fund, said the decision “will lead to more lives lost to abortion, and will increase the number of mothers who suffer physical and psychological harm from chemical abortions.”
___
Associated Press writer David Crary contributed to this story from New York.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
___
This story was first published on December 16, 2021. It was updated on February 24, 2022 to delete an incorrect description of the drug misoprostol as a hormone blocker.
By LINDSEY TANNER
Containers of the medication used to end an early pregnancy sit on a table inside a Planned Parenthood clinic, Oct. 29, 2021, in Fairview Heights, Ill. A report released Thursday, Feb. 24, 2022 says most U.S. abortions are now done with pills rather than surgery. The trend spiked during the pandemic as telemedicine increased and pills by mail were allowed. (AP Photo/Jeff Roberson)
More than half of U.S. abortions are now done with pills rather than surgery, an upward trend that spiked during the pandemic with the increase in telemedicine, a report released Thursday shows.
In 2020, pills accounted for 54% of all U.S. abortions, up from roughly 44% in 2019.
The preliminary numbers come from the Guttmacher Institute, a research group that supports abortion rights. The group, by contacting providers, collects more comprehensive abortion data than the U.S. government.
Use of abortion pills has been rising since 2000 when the Food and Drug Administration approved mifepristone — the main drug used in medication abortions.
The new increase “is not surprising, especially during COVID,” said Dr. Marji Gold, a family medicine physician and abortion provider in New York City. She said patients seeking abortions at her clinic have long chosen the pills over the medical procedure.
The pandemic prompted a rise in telemedicine and FDA action that allowed abortion pills to be mailed so patients could skip in-person visits to get them. Those changes could have contributed to the increase in use, said Guttmacher researcher Rachel Jones.
The FDA made the change permanent last December, meaning millions of women can get a prescription via an online consultation and receive the pills through the mail. That move led to stepped-up efforts by abortion opponents to seek additional restrictions on medication abortions through state legislatures.
The procedure includes mifepristone, which blocks a hormone needed for pregnancy to continue, followed one or two days later by misoprostol, a drug that causes cramping that empties the womb. The combination is approved for use within the first 10 weeks of pregnancy, although some health care providers offer it in the second trimester, a practice called off-label use.
So far this year, 16 state legislatures have proposed bans or restrictions on medication abortion, according to the Guttmacher report.
It notes that in 32 states, medication abortions must be prescribed by physicians even though other health care providers including physician assistants can prescribe other medicines. And mailing abortion pills to patients is banned in three states — Arizona, Arkansas and Texas, the report says.
According to the World Health Organization, about 73 million abortions are performed each year. About 630,000 abortions were reported to the U.S. Centers for Disease Control and Prevention in 2019 although information from some states is missing. Guttmacher’s last comprehensive abortion report dates to 2017; the data provided Thursday comes from an update due out later this year.
Global numbers on rates of medication versus surgical abortions are limited. Data from England and Wales show that medication abortions have outpaced surgical abortions for about 10 years.
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Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Containers of the medication used to end an early pregnancy sit on a table inside a Planned Parenthood clinic, Oct. 29, 2021, in Fairview Heights, Ill. A report released Thursday, Feb. 24, 2022 says most U.S. abortions are now done with pills rather than surgery. The trend spiked during the pandemic as telemedicine increased and pills by mail were allowed. (AP Photo/Jeff Roberson)
More than half of U.S. abortions are now done with pills rather than surgery, an upward trend that spiked during the pandemic with the increase in telemedicine, a report released Thursday shows.
In 2020, pills accounted for 54% of all U.S. abortions, up from roughly 44% in 2019.
The preliminary numbers come from the Guttmacher Institute, a research group that supports abortion rights. The group, by contacting providers, collects more comprehensive abortion data than the U.S. government.
Use of abortion pills has been rising since 2000 when the Food and Drug Administration approved mifepristone — the main drug used in medication abortions.
The new increase “is not surprising, especially during COVID,” said Dr. Marji Gold, a family medicine physician and abortion provider in New York City. She said patients seeking abortions at her clinic have long chosen the pills over the medical procedure.
The pandemic prompted a rise in telemedicine and FDA action that allowed abortion pills to be mailed so patients could skip in-person visits to get them. Those changes could have contributed to the increase in use, said Guttmacher researcher Rachel Jones.
The FDA made the change permanent last December, meaning millions of women can get a prescription via an online consultation and receive the pills through the mail. That move led to stepped-up efforts by abortion opponents to seek additional restrictions on medication abortions through state legislatures.
The procedure includes mifepristone, which blocks a hormone needed for pregnancy to continue, followed one or two days later by misoprostol, a drug that causes cramping that empties the womb. The combination is approved for use within the first 10 weeks of pregnancy, although some health care providers offer it in the second trimester, a practice called off-label use.
So far this year, 16 state legislatures have proposed bans or restrictions on medication abortion, according to the Guttmacher report.
It notes that in 32 states, medication abortions must be prescribed by physicians even though other health care providers including physician assistants can prescribe other medicines. And mailing abortion pills to patients is banned in three states — Arizona, Arkansas and Texas, the report says.
According to the World Health Organization, about 73 million abortions are performed each year. About 630,000 abortions were reported to the U.S. Centers for Disease Control and Prevention in 2019 although information from some states is missing. Guttmacher’s last comprehensive abortion report dates to 2017; the data provided Thursday comes from an update due out later this year.
Global numbers on rates of medication versus surgical abortions are limited. Data from England and Wales show that medication abortions have outpaced surgical abortions for about 10 years.
___
Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
