FDA backs expanded use of medical abortion pill

Reuters News
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Posted: Mar 30, 2016 12:21 PM

By Toni Clarke and Jilian Mincer

WASHINGTON/NEW YORK (Reuters) - American women will have cheaper and easier access to abortion by medication after a decision by the Food and Drug Administration on Wednesday to relax restrictions on the use of abortion pill Mifeprex that were in place for over a decade.

The change set off another front in the fight over abortion that has spilled into the U.S. presidential election campaign and come up again in the Supreme Court in recent weeks.

The FDA eased access to Mifeprex by updating the prescribing information on the drug's label, thus expanding use to 70 days of gestation from the current 49 days, cutting the recommended dose of the drug and reducing the number of required visits to a doctor.

In practice, many abortion providers had moved away from the previous restrictions over the years but states like Texas, North Dakota and Ohio have laws that restrict medication abortions by requiring prescription of the drug strictly according to the old label.

The FDA "has finally caught up to the evidence-based practice in the United States," said Vicki Saporta, president and chief executive of the National Abortion Federation, an organization of abortion providers.

Anti-abortion campaigners condemned the expanded access to the drug, which was in response to an application and clinical data submitted by the manufacturer, Danco Laboratories.

"It's expanding the customer base for the abortion industry," Randall O'Bannon, director of education and research for the National Right to Life organization.

Danco spokeswoman Abby Long declined to provide sales data for the pill but said it has been used by more than 2.75 million women in the United States since it was approved in 2000.

During a medication abortion, the drugs first block hormone progesterone and then causes the uterus to contract and empty.

Long a battlefield in U.S. culture wars, abortion became an issue in the 2016 presidential election campaign on Wednesday when Republican front-runner Donald Trump said that women who end pregnancies should face punishment if the United States bans

abortion.

His comments triggered a torrent of negative reactions and the billionaire later rowed back the remarks.

Earlier this month, the Supreme Court took up its biggest abortion case in years. It deals with a Texas law that imposes strict regulations on abortion doctors and clinic buildings.

DATA FROM STUDIES

In addition to expanding access to abortion for women in states with restrictive laws, the change on Wednesday "has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider," said Saporta.

In recent years, some clinics stopped offering medical abortions because women could not afford the higher costs and increased doctor visits.

The FDA update reflects data from 22 studies including almost 31,000 women that showed the existing information is out of date, said Danco, a privately held company.

Those studies show that patients only need to take a third of the dose recommended on the old label, she said.

An estimated 83 percent of U.S. providers have already moved away from the old recommendations, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

In other areas of medicine, doctors routinely prescribe drugs "off label" in ways not indicated on the approved label. They are for the most part allowed to do this though companies are not allowed to promote products for off label uses.

Mifeprex was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

Under the new label, patients will take one 200 mg tablet of Mifeprex on day one instead of three 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.

Under the old label, women were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label recommends that they return between seven and 14 days for n assessment.

(Additional reporting by Jon Herskovitz in Austin; Editing by Alistair Bell)