The U.S. Food and Drug Administration simplified the regulations for using pills to induce an abortion, making the procedure more easily available to American women even as several states consider efforts to curtail the practice.
The U.S. Food and Drug Administration simplified the regulations for using pills to induce an abortion, making the procedure more easily available to American women even as several states consider efforts to curtail the practice.
The medication, known as Mifeprex, now can be taken by women who are as much as 10 weeks pregnant, up from 7 weeks, according to a new label posted on the agency’s website. The dose was also cut by two-thirds to 200 milligrams, reducing the risk of side effects.
The agency eliminated a requirement that women must take a second drug in their provider’s office, instead allowing them to take it at home. They’re still required to have an in-person follow-up appointment a week or two after taking the drug, known chemically as mifepristone, to ensure the pregnancy was terminated. The changes will make medical abortions more effective, less expensive and more widely available, particularly in poor and rural areas, proponents of the change said.
“The updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices,” said Mark DeFrancesco, president of the American Congress of Obstetricians and Gynecologists. “Extending approved use of mifepristone through 70 days gestation is proven to be safe and effective, and will give women more time to make the decision that is right for them.”
Restricting Access
The changes come as several states, including Texas and North Dakota, have cracked down on health-care providers who prescribe the drugs needed for a medical abortion and proposed other changes that would make the procedures more difficult to get. More than 200 abortion restrictions have been passed nationwide since a Republican-led state legislative push began in 2011.
The drug, initially known as RU-486, was first approved in September 2000 after a seven-year effort by the Clinton administration to make the pill available in the U.S. It’s sold by Danco Laboratories LLC, a closely held company that licensed the medicine from the Population Council, a New York-based contraception research group.
Texas, North Dakota and Ohio require that women take the medicine according to the approved label, which until now mandated three office visits and a high dose of the drug, said Susan Wood, executive director of the Jacobs Institute of Women’s Health Services at George Washington University. The original label was based on studies performed two decades ago, with recent research showing less medicine is necessary, she said.
‘Fewer Barriers’
“With this updated label, women in states that have passed laws requiring providers to follow the FDA-approved label now face fewer barriers to a medical abortion,” Wood said.
The new label follows recommendations by Planned Parenthood Federation of America, the World Health Organization, the American Medical Association, the American Congress of Obstetricians and Gynecologists and the Society for Family Planning.
An abortion done with medication is safe 99 percent of the time and successfully ends a pregnancy 98 percent of the time, said Raegan McDonald-Mosley, chief medical officer of Planned Parenthood.
“This is another affirmation from the FDA that medication abortion is a safe and effective option to end an early pregnancy,” McDonald-Mosley said.
Mifeprex blocks progesterone receptors, cutting off the body’s access to the hormone that’s needed to maintain a pregnancy. A single dose of the drug, followed by another medicine known as misoprostol taken a day or two later, causes a miscarriage. It’s different than the morning-after pill, taken immediately after unprotected sex, which prevents pregnancy rather than ends it.
To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortezbloomberg.net To contact the editors responsible for this story: Cecile Daurat at cdauratbloomberg.net Stephen West