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FDA revises instructions for use of abortion drug Mifeprex; women's health advocates hail victory

"Updating the label ... represents a significant step forward for science, for women," abortion rights organization Planned Parenthood said Wednesday.

By Doug G. Ware
The U.S. Food and Drug Administration on Wednesday announced revisions to its official prescribing label for the abortion drug Mifeprex to include lower dosages and longer use. Abortion rights advocates hailed the change as a victory for women's health in the United States. File photo by UPI | <a href="/News_Photos/lp/1e4c0a9ba49a73cbcaa21197a4cdbe72/" target="_blank">License Photo</a>
The U.S. Food and Drug Administration on Wednesday announced revisions to its official prescribing label for the abortion drug Mifeprex to include lower dosages and longer use. Abortion rights advocates hailed the change as a victory for women's health in the United States. File photo by UPI | License Photo

SILVER SPRING, Md., March 30 (UPI) -- The U.S. Food and Drug Administration on Wednesday announced that it has relaxed its official requirements regarding the use of the abortion drug Mifeprex, which was based on outdated 1990s medical evidence.

The FDA said the change revises the regimen it wants providers to follow when prescribing the drug to patients.

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Doctors and health experts have said the original agency label was based on old clinical trial evidence from the late 1990s that goes against the currently accepted standards of medical practice.

The FDA's revised label, for example, reduces the number of physician visits abortion-seeking women have to make and reduces the dosage of the drug, which doctors have found to be more effective.

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The agency's label change also allows pregnant women to take the drug for three weeks longer -- for a total of 70 days -- than the FDA's previous stipulation.

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The announcement is a victory for abortion rights advocates, who have been fighting for years against various state laws that oppose medically induced abortion.

"This is a huge step in increasing access to medication abortion and it comports with the scientific evidence," Guttmacher Institute associate Elizabeth Nash, who helps track female reproductive health issues, said.

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Many doctors have been prescribing Mifeprex against the FDA's official instructions in favor of the new regimen -- a practice known in the industry as off-label use. However, that led lawmakers in some states to seek legal requirements that the FDA's label be followed to the letter -- a tactic some critics have said is intended to make drug-induced abortions more difficult to obtain.

The FDA approved Mifeprex, known generically as mifepristone, in 2000. When combined with another drug, misoprostol, it induces a miscarriage.

Republican presidential candidate Donald Trump delivers remarks to the American Israel Public Affairs Committee's Policy Conference in Washington, D.C., Monday, March 21, 2016. Trump told MSNBC in an interview Wednesday that he would favor outlawing abortion as president, and even "some form of punishment" when women obtain them illegally. Photo by Kevin Dietsch/UPI

On Wednesday, Planned Parenthood and the American Congress of Obstetricians and Gynecologists applauded the FDA's label update.

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"ACOG is pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices and includes many of the recommendations that ACOG had presented to the agency," the organization said in a statement.

"Access to reproductive services, including abortion care, is essential for women's health. Medication abortion, performed through a combination of mifepristone and misoprostol, has provided a safe, effective option for induced abortion that has benefited millions of women," the ACOG added.

"This is another affirmation from the FDA that medication abortion is a safe and effective option to end an early pregnancy," Planned Parenthood Chief Medical Officer Raegan McDonald-Mosley said in response Wednesday. "Studies show medication abortion has a 99 percent safety record, and that medication abortion is up to 98 percent effective in ending an early pregnancy."

In its reaction, Planned Parenthood also noted that the newly FDA-sanctioned regimen has long been recognized as favorable by medical groups, including the ACOG and the American Medical Association.

"We have actually had the protocols approved today in place at Planned Parenthood for some time," McDonald-Mosley continued. "But given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for healthcare providers who want to give our patients the highest quality care."

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The FDA's announcement comes amid a new round of abortion-related debate among the Republican presidential candidates.

GOP front-runner Donald Trump said Wednesday that as president he would not only outlaw abortion, but also favor "some form of punishment" for when women obtain illegal abortions.

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"You know you'll go back to a position like where they had, where people perhaps will go to illegal places... But you have to ban it," Trump told MSNBC's Chris Matthews in the interview, scheduled to air Wednesday.

"There has to be some form of punishment."

Trump later attempted to clarify his remarks.

Fellow Republican candidate John Kasich, though, emphatically disagreed with Trump's remarks, as did Democratic contenders Hillary Clinton and Bernie Sanders.

"Just when you thought it couldn't get worse. Horrific and telling," Clinton tweeted.

"Your Republican front-runner, ladies and gentlemen," Sanders similarly offered. "Shameful."

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