New FDA Rules Improve Abortion Access in Several States
By Jim Siegel
Abortion rights advocates in Ohio celebrated a rare victory Wednesday when the federal Food and Drug Administration relaxed requirements for a medication that induces abortion, expanding access to the procedure.
The decision is expected to have a direct effect on states like Ohio, Texas and North Dakota, which 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Many doctors say the original labels, based on clinical evidence from the 1990s, were outdated and that the state laws went against accepted medical practice and made it harder for women to get abortions.
Calling the ruling a "game changer for Ohio women," Kellie Copeland, executive director of NARAL Pro-Choice Ohio, said it means that Ohio doctors no longer have to follow "outdated, draconian protocol enacted by anti-choice politicians."
"Today, medication abortion care is once again a real option for Ohio women," she said.
The changes announced Wednesday:
--Reduce the number of trips women have to make to a doctor from three to two in most states.
--Increase the number of days that women may use the medication to induce abortion from 49 to 70 after the beginning of their last menstrual period, experts said.
--Reduce 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 side effects.
In most states, doctors had been following the medically accepted regimen, despite the fact that the label advised otherwise. That is fairly common in medical practice and is known as off-label use.
''This is a huge step in increasing access to medication abortion, and it comports with the scientific evidence,'' said Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, a nonprofit group focused on reproductive health. She said medication abortions accounted for about a quarter of all abortions in 2011.
Michael Gonidakis, president of Ohio Right to Life and the appointed president of the Ohio State Medical Board, said the FDA essentially affirmed the risks of taking mifepristone. He said the drug causes "severe and negative harm to women."
"In Ohio, we have a number of reported cases of botched chemical abortions logged with the State Medical Board," he said. "The tragedy is that the FDA just allowed three additional weeks for women and their babies to be placed in harm's way."
The FDA first approved the drug, formerly known as RU-486, in 2000. It works by blocking receptors of progesterone, an important hormone in pregnancy. When taken with another drug, misoprostol, it induces miscarriage.
(c)2016 The Columbus Dispatch (Columbus, Ohio)