FDA changes label requirements for abortion-inducing drug, potentially expanding its usage

The FDA has approved new labeling for the drug Mifeprex that could make it easier for women in some states to access medication abortions.

Similarly, several providers already have given patients a lower dose of misoprostol or have allowed women to take Mifeprex at home in accordance with the most recent medical research, she said.
Abortion rights advocates say that laws requiring the FDA protocol are a gambit to place burdens on a method of abortion that offers women a greater degree of flexibility and privacy.
We are delighted that the FDA has approved a label change, which brings the label for mifepristone in-line with scientific research and evidence-based practice.
It works by blocking receptors of progesterone and when taken with another drug called Misoprostol, it induces a miscarriage. Around 90% of the 1.1 million USA abortions yearly come in the first trimester of pregnancy, and the pills now account for about one-third of these early abortions.
Planned Parenthood, in its site’s education section, attempts to claim that the abortion pill is “used up to 63 days – 9 weeks – after the first day of a woman’s last period”, even while knowing that 104 of its own clinics use the abortion pill up to 10 weeks. Over the years, however, doctors have found that a 200-milligram dose is just as effective and causes fewer unpleasant side effects, such as nausea, vomiting, soreness, and fever.
The American Congress of Obstetricians and Gynecologists also backed the FDA decision.
In some cases, the laws function as de facto bans on medication abortion: abortion providers suing to block these requirements have testified that the old regimen is so far beneath the standard of care that prescribing the drugs would be irresponsible. “Additionally 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 unsafe drug”. “The FDA label has finally caught up to the evidence based practice in the United States”. Furthermore, alternative medicine abortion is also made affordable especially for women in low-income families or those in rural areas.
A number of other abortion clinics refuse to perform medication abortions past eight or nine weeks of pregnancy.
But three states – Ohio, Texas and North Dakota – had passed laws saying doctors must follow the FDA label, which was written based on early trials of the drug and didn’t reflect the changes in medical practice over the past 15 years.
State-reported figures show drug-induced abortions in Texas decreased from 19,081 medical abortions in 2012 to 16,756 in 2013.
The FDA’s exact changes can be viewed on a PDF of the abortion medication’s label on the FDA website.
While the change increases options for women seeking an abortion, it doesn’t increase access.
“They will not be following the (current) FDA recommendations if this bill becomes law”, said state Rep. Randall Friese, a Tucson Democrat and a surgeon who asked Ducey to veto the bill. “People who visit our clinics deserve options for abortion care without worrying about medically unnecessary obstacles and this change allows for more women to get the care they deserve”, said Amy Hagstrom Miller, president and CEO of Whole Woman’s Health, a chain of clinics battling restrictions on abortion in Texas before the Supreme Court.