FDA to soften rules for use of abortion pill

The FDA has approved new labeling for the drug Mifeprex that could make it easier for women in some states to access medication abortions.

Mifeprex (its trade name is mifepristone) is also known as “the abortion pill” or the “early option pill.”

It was first approved by the Food and Drug Administration in 2000, and has since been used by more than 2.75 million women in the United States, according to Danco Laboratories, the company that manufactures the drug.

Even with the new labeling, Mifeprex is only available to women who are in their first trimester of pregnancy. It works by blocking a hormone called progesterone that is needed for a pregnancy to continue.

ADVERTISEMENT
0 seconds of 0 secondsVolume 0%
Press shift question mark to access a list of keyboard shortcuts
00:00
00:00
00:00
 

It is usually used in conjunction with another drug — misoprostol —which causes the uterus to actively contract and end the pregnancy.

The new FDA-approved Mifeprex label will include several changes that were recommended by the World Health Organization in 2003 and were endorsed more recently by the American Medical Association and the American College of Obstetricians and Gynecologists.

It extends the amount of time that a pregnant woman can take the drug from seven weeks after her last menstrual period to 10 weeks.

It says women can take the drug in the comfort of their own home rather than in the presence of a physician.

It reduces the number of visits to a doctor’s office or clinic that a woman has to make after taking the drug from two to zero in some states.

It lowers the recommended dose of misoprostol from 600 milligrams to 200 milligrams, which will lessen the side effects of the drug and make it less expensive.

Health care experts said the new labeling reflects what many reproductive health care providers across the country have been doing for years.

Doctors often practice “off label” with all sorts of drugs — telling their patients to take a little more or a little less than a recommended dose, said Reagan McDonald-Mosley, chief medical officer of Planned Parenthood Federation of America.

Similarly, several providers already have given patients a lower dose of misoprostol or have allowed women to take Mifeprex at home in accordance with the most recent medical research, she said.

Therefore, the FDA’s announcement will mostly affect women and providers in Ohio, Texas and North Dakota. That’s because legislators in those three states have enacted laws that require that Mifeprex be given in strict accordance with the regimen outlined on the drug’s label.

Lawmakers passed similar restrictions in Arizona, Arkansas and Oklahoma, but those have been blocked by court orders.

“Those laws made it impossible for doctors to follow the latest science in those states,” said Dr. Beverly Winikoff, president of Gynuity Health Projects, an organization that advocates for women’s reproductive rights. “Now, when you follow the label, you are following the latest science.”

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

Students from Explorer Middle School gather Wednesday around a makeshift memorial for Emiliano “Emi” Munoz, who died Monday, May 5, after an electric bicycle accident in south Everett. (Aspen Anderson / The Herald)
Community and classmates mourn death of 13-year-old in bicycle accident

Emiliano “Emi” Munoz died from his injuries three days after colliding with a braided cable.

Danny Burgess, left, and Sandy Weakland, right, carefully pull out benthic organisms from sediment samples on Thursday, May 1, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
‘Got Mud?’ Researchers monitor the health of the Puget Sound

For the next few weeks, the state’s marine monitoring team will collect sediment and organism samples across Puget Sound

Everett postal workers gather for a portrait to advertise the Stamp Out Hunger Food Drive on Wednesday, May 7, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
Snohomish County letter carriers prepare for food drive this Saturday

The largest single-day food drive in the country comes at an uncertain time for federal food bank funding.

Everett
Everett considers ordinance to require more apprentice labor

It would require apprentices to work 15% of the total labor hours for construction or renovation on most city projects over $1 million.

Snohomish County prosecutor Kara Van Slyck delivers closing statement during the trial of Christian Sayre at the Snohomish County Courthouse on Thursday, May 8, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
Jury deliberations begin in the fourth trial of former Everett bar owner

Jury members deliberated for about 2 hours before Snohomish County Superior Court Judge Millie Judge sent them home until Monday.

Christian Sayre sits in the courtroom before the start of jury selection on Tuesday, April 29, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
Christian Sayre timeline

FEBRUARY 2020 A woman reports a sexual assault by Sayre. Her sexual… Continue reading

Helion's 6th fusion prototype, Trenta, on display on Tuesday, July 9, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Helion celebrates smoother path to fusion energy site approval

Helion CEO applauds legislation signed by Gov. Bob Ferguson expected to streamline site selection process.

Everett Historic Theater owner Curtis Shriner inside the theater on Tuesday, May 13, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
Historic Everett Theatre sale on horizon, future uncertain

With expected new ownership, events for July and August will be canceled. The schedule for the fall and beyond is unclear.

A “SAVE WETLANDS” poster is visible under an seat during a public hearing about Critical Area Regulations Update on ordinance 24-097 on Wednesday, May 14, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
Snohomish County Council passes controversial critical habitat ordinance

People testified for nearly two hours, with most speaking in opposition to the new Critical Areas Regulation.

An apartment building under construction in Olympia, Washington in January 2025. (Photo by Bill Lucia/Washington State Standard)
Next stop for Washington housing: More construction near transit

Noticed apartment buildings cropping up next to bus and light rail stations?… Continue reading

Jacquelyn Jimenez Romero / Washington State Standard
Lt Gov. Denny Heck presiding over the Senate floor on April 27.
Washington tries to maintain B.C. ties amid Trump era tensions

Lt. Gov. Denny Heck and others traveled to Victoria to set up an interparliamentary exchange with British Columbia, and make clear they’re not aligned with the president’s policies or rhetoric.

Marysville
Marysville talks middle housing at open house

City planning staff say they want a ‘soft landing’ to limit the impacts of new state housing laws. But they don’t expect their approach to slow development.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.