The move by the FDA is expected to increase access to the medication and is a victory for abortion-rights advocates who are fighting laws in states like Texas, North Dakota and Ohio that required providers to follow the original FDA label requirements when using the drug.
But the original label is outdated say many doctors. The label requirements are based on clinical studies from the 1990s, and state laws requiring doctors to adhere to the labels goes against accepted medical practice and actually makes it harder for women to get abortions, reports Newser.
Danco Laboratories’ abortion pill, Mifeprex, also known as mifepristone, is used in combination with another drug, misoprostol, to end a pregnancy. But doctors found that Mifeprex was safer and more effective than previously thought, and at lower doses.
The FDA has reduced the number of visits a patient has to make to a doctor from three to two times in most states, and also increased the number of days a woman has to take the medication from 49 to 70 days after the beginning of her last menstrual period. The new requirement also reduces the amount of Mifeprex from 600 mg. to 200 mg. Reducing the dosage will not only decrease side-effects but also reduce the cost of the medication, reports Newsweek.
“This is a huge step in increasing access to a medication-induced abortion and it comports with the scientific evidence,” said Elizabeth Nash, a senior state issues associate at the Guttmacher Institute, which tracks women’s reproductive health issues, according to the New York Times.
Strange as it may seem, doctors in most states have been following the medically-accepted practice instead of following the old label requirements, a practice known as “off-label use.” This practice caused a number of states to put legal requirements on doctors to follow the FDA labeling, period, saying they were trying to protect women’s health.
These restrictions on the use of Mifeprex have been passed but have also been blocked by court order in Arkansas, Oklahoma and Arizona. Of course, in Arizona, legislators have passed another measure to make doctors adhere to the old labeling instructions, but it hasn’t been signed yet.
We can expect a backlash by abortion opponents in many states, especially those with archaic laws regarding how Mifeprex is to be prescribed. The big question yet to be answered will be if state legislatures will go along with the FDA requirements.
