Women will now find it easier to use life-ending medication
The U.S. Food and Drug Administration on Wednesday relaxed the requirements for taking a medication once known as RU-486. The drug, long controversial in the United States, was originally developed by the French pharmaceutical company Roussel-Uclaf. After a long public debate, the FDA approved its distribution in the United States in September 2000, near the end of the Bill Clinton administration.
But the FDA labeling restricted its use to pregnant women by the 49th day after the beginning of their last menstrual period. Now the agency said it’s safe to take the pill up to 70 days after that event. The new labeling also reduces the dosage of the drug, called mifepristone, from 600 milligrams to 200. Most medical societies had said the previous dosage was too high, and abortion-rights advocates said it increased the cost and the side effects of the procedure, according to The New York Times.
Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, told the Times that abortions done this way accounted for about a quarter of all pregnancy terminations in 2011, the last year measured by the institute.
The move was a victory for abortion-rights advocates who had been fighting laws in states like Texas, North Dakota and Ohio that required providers to follow the requirements on the original FDA labels for the drug when conducting abortions by medication. Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions.
The changes announced on Wednesday reduce the number of trips women have to make to a doctor from three to two in most states.
The drug works by blocking receptors of progesterone, an important hormone in pregnancy. When taken with another drug, misoprostol, it induces miscarriage. Since the original FDA approval, states have passed a number of laws restricting the drug’s use. Some require medical professionals who administer the drug to be licensed physicians. Others require the prescribing doctor to be physically present with the patient.
Reacting to the development, Eric Scheidler, executive director of the Pro-Life Action League, called women the “victims,” as the FDA eliminates “cautionary guidance of physician monitoring, increases the possibility of abortion pill failure and escalates the potential for deadly complications.”
“At least eight deaths have been documented of women using mifepristol for abortion, all of them using the off-label protocol that the FDA has just approved,” Scheidler said.
And U.S. Congressman Chris Smith, a Republican from New Jersey who chairs the Bipartisan Congressional Pro-Life Caucus, pointed out that the new label eliminates the follow-up visit to the physician prior to taking the second part of the drug protocol and expands who may administer this dangerous drug.
“Not only is mifepristone used to kill babies, it is a poison that has harmed and even killed women,” Smith said. “Yet even with this record, in the last months of his term, President Obama has bowed to pressure from his abortion cronies and has further expanded the use of the abortion pill, putting the health and lives of even more women and children at risk.”
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