WASHINGTON – On Thursday, the Food and Drug Administration permanently eased some restrictions on abortion pills, including a longstanding requirement that medications must be picked up in person.
Officials said scientific review supported expanding access and allowing more pharmacies – including mail-order services – to dispense the drugs.
But prescribing will still be limited to doctors who obtain special certification. Additionally, the agency said dispensing pharmacies will need to be registered with the FDA.
The ruling is the latest change in the polarized legal battle over medical abortion, which has only intensified amid the disruptions of the COVID-19 pandemic. This is sure to spur legal challenges and more restrictions in Republican-led states.
Three RU-486 Mifeprex abortion pills are held in a hand December 1, 2000 in Granite City, Illinois. (Credit: Bill Grenblatt/Getty Images)
Earlier this year, the FDA stopped enforcing the in-person waiver requirement due to the pandemic. Under Thursday’s decision, the agency will permanently drop the rule, which has long been opposed by medical societies, including the American Medical Association, which say the restrictions offer no clear benefit to patients.
The FDA’s latest scientific review stems from a 2017 lawsuit filed by the American Civil Liberties Union, which argued that the agency’s restrictions block or delay medical care, especially for people with low incomes and rural communities.
Doctors who prescribe the drug, mifepristone, will have to certify that they can provide emergency care to deal with its potential side effects, including excessive bleeding, FDA officials said Thursday.
The change still means many more doctors will be able to prescribe the drug and most Americans will be able to fulfill orders at thousands of pharmacies, including via online and mail-order services.
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The effect will vary by state. More than a dozen Republican-led states have passed measures that limit access to the pills, including banning delivery by mail.
The increased use of mail-order pills could pose a dilemma for the anti-abortion movement, given that its leaders generally say they are not in favor of criminalizing the actions of women seeking abortions and because deliveries by mail 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 reverse the Roe v. Wade which guarantees the right to abortion throughout the country.
Roe’s disappearance would likely prompt at least 20 Republican-ruled states to impose sweeping bans, while perhaps 15 Democratic-ruled states would reaffirm their support for abortion access. More complicated would be politically divided states where fights over abortion laws could be fierce.
Medical abortion has been available in the United States since 2000, when the FDA first approved mifepristone to terminate pregnancies up to 10 weeks old. Taken with a hormone blocker called misoprostol, it is called the abortion pill.
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About 40% of all abortions in the United States are now performed by medication — rather than surgery — and this option has become more crucial during the COVID-19 pandemic.
At the time of approval, the FDA placed limits on how the drug could be distributed, including banning it from regular pharmacies and requiring all physicians supplying the drug to undergo special certification. Women are also required to sign a form indicating that they understand the potential risks of the drug.
Near the start of the outbreak, the FDA waived in-person requirements for virtually all drugs, but left them in place for mifepristone.
This sparked a lawsuit from the American College of Obstetricians and Gynecologists, which successfully overturned the restriction in federal court. The Trump administration then appealed the decision 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 dispensing limits during the current public health emergency.
“The FDA’s decision will be a tremendous relief to countless abortion and miscarriage patients,” said ACLU attorney Georgeanne Usova. “However, it is disappointing that the FDA has not repealed all of its medically unnecessary restrictions on mifepristone and these remaining hurdles should also be lifted,”
AP Writer David Crary contributed to this story from New York.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.