AP

US regulators lift in-person restrictions on abortion pill

Dec 16, 2021, 4:59 PM
FILE - 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)
(AP Photo/Charlie Neibergall, file)

WASHINGTON (AP) — The Food and Drug Administration on Thursday permanently loosened several key restrictions on abortion pills, including a long-standing requirement that the medication be picked up in person.

Under the change, millions of American women will 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 eliminating the restriction that limited 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 the year the FDA stopped enforcing the in-person requirement because of 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, that say the restrictions offer no clear benefit to patients.

The FDA’s latest scientific review stems from a 2017 lawsuit 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 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 prescribe the drug and Americans will be able to fill orders at thousands of 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 a hormone blocker 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 a 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 understand the medication’s potential risks. The FDA said Thursday there have been 26 deaths associated with the drug since 2000.

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 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.”

 

Today’s Top Stories

AP

DOHA, QATAR - NOVEMBER 25: A giant flag of IR Iran on the pitch prior to the FIFA World Cup Qatar 2...
ALI ABDUL-HASSAN and ABBY SEWELL Associated Press

US-Iran match reflects a regional rivalry for many Arab fans

The U.S. team’s must-win World Cup match against Iran will be closely watched across the Middle East, where the two nations have been engaged in a cold war for over four decades and where many blame one or both for the region’s woes.
7 days ago
Irene Cara in 'Fame' (Photo courtesy of Mgm/Kobal, Shutterstock)...
MARK KENNEDY, AP Entertainment Writer

‘Fame’ and ‘Flashdance’ singer-actor Irene Cara dies at 63

singer-actress Irene Cara, who starred and sang the title cut from the 1980 hit movie “Fame” and then belted out the era-defining hit “Flashdance ... What a Feeling” from 1983's “Flashdance,” has died. She was 63.
9 days ago
The U.S. Coast Guard ship Bernard C. Webber, leaves the coast guard base, Monday, July 19, 2021, in...
Associated Press

‘Miracle’: Missing cruise ship passenger found OK in water

The U.S. Coast Guard says a passenger who went overboard from a cruise ship in the Gulf of Mexico was rescued on Thanksgiving after likely being in the water for hours.
10 days ago
FILE - A Montana man was sentenced to three years in prison for his role in the Capitol riot. (AP P...
The Associated Press

Montana man gets 3 years in prison for role in Capitol riot

A Montana man will spend three years in federal prison for his role in the Jan. 6, 2021, riot at the U.S Capitol.
11 days ago
Debbie, left, and Chet Barnett place flowers at a memorial outside of the Chesapeake, Va., Walmart ...
The Associated Press

Walmart shooter left ‘death note,’ bought gun day of killing

According to authorities in Virginia, the Walmart shooter bought his gun just hours prior to killing six employees.
11 days ago
Dry lakebed...
Kira Hoffelmeyer

Lawsuit looms over tiny fish in drought-stricken West

RENO, Nev. (AP) — Conservationists have notified U.S. wildlife officials that they will sue over delayed decisions related to protections for two rare fish species that are threatened by groundwater pumping in the drought-stricken West. The Center for Biological Diversity sent a formal notice of intent to sue the Fish and Wildlife Service last week […]
13 days ago

Sponsored Articles

Spicy Homemade Loaded Taters Tots...
Macey's

5 game day snacks for the whole family (with recipes!)

Try these game day snacks to make watching football at home with your family feel like a special occasion. 
Happy joyful smiling casual satisfied woman learning and communicates in sign language online using...
Sorenson

The best tools for Deaf and hard-of-hearing workplace success

Here are some of the best resources to make your workplace work better for Deaf and hard-of-hearing employees.
Team supporters celebrating at a tailgate party...
Macey's

8 Delicious Tailgate Foods That Require Zero Prep Work

In a hurry? These 8 tailgate foods take zero prep work, so you can fuel up and get back to what matters most: getting hyped for your favorite
christmas decorations candles in glass jars with fir on a old wooden table...
Western Nut Company

12 Mason Jar Gift Ideas for the 12 Days of Christmas [with recipes!]

There are so many clever mason jar gift ideas to give something thoughtful to your neighbors or friends. Read our 12 ideas to make your own!
wide shot of Bear Lake with a person on a stand up paddle board...

Pack your bags! Extended stays at Bear Lake await you

Work from here! Read our tips to prepare for your extended stay, whether at Bear Lake or somewhere else nearby.
young boy with hearing aid...
Sorenson

Accommodations for students who are deaf and hard of hearing

These different types of accommodations for students who are deaf and hard of hearing can help them succeed in school.
US regulators lift in-person restrictions on abortion pill