Conservative group Alliance Defending Freedom sues FDA in a bid to overturn abortion pill approval In 2000, the Food and Drug Administration (FDA) granted expedited approval for the abortion medication Mifeprex. Mifeprex worked by blocking a hormone called progesterone that is essential in the continuity of a pregnancy. The drug is usually accompanied by the use of another medication called misoprostol which is subsequently used to clear the uterus.
In more recent developments regarding the drug, the agency had allowed for the drug to be delivered via mail. Before this point, the drug could only be prescribed in person but now people can get access to the drug through phone or video consultations or by filling out online forms. To avail this service, candidates must be in states where abortion is legal. Moreover, in 2016, the FDA eased restrictions on the pill by allowing its use till 10 weeks of pregnancy, 3 weeks more than the original 7-week deadline set previously.
With the Supreme Court’s decision to overturn Roe vs. Wade in June, according to the New York Times, medicated abortions now account for more than half the abortions in the U.S. This method is significantly cheaper and less invasive than a surgical procedure.
Recently, however, a conservative group by the name of Alliance Defending Freedom has sued the FDA and the Health and Human Services Department in Armadillo, Texas on the behalf of 4 antiabortion medical organizations, including the American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical & Dental Associations, as well as 4 physicians who have prescribed patients with the drug in the past.
The lawsuit claims that health agencies did not adequately study the drug before approving it and that the drug is unsafe. The suit further explains that despite not being a life-saving therapy for a life-threatening illness, the drug was approved under an expedited process, and the speedy consideration for such a drug was unconventional.
A senior counsel member of the Alliance Defending Freedom, Julie Blake elaborated that considering that pregnancy is not an illness and abortion-inducing drugs do not provide a therapeutic benefit but in fact, pose a threat to the mother.
In contrast to this opinion, a fellow with Physicians for Reproductive Health, Loren Colson, has called mifepristone “an incredibly safe medication.”
“It’s been well-studied and much safer than a lot of things you can find over the counter,” Colson added. “If they (ADF) are trying to argue the safety, they have very little ground to stand on. It’s just a clear and blatant attack on abortion.”
Greer Donley, an associate professor of law at the University of Pittsburgh, has denounced the group’s safety claims as ludicrous. Donely has gone as far as to say that Mifepristone is significantly safer than other drugs available in the market including Penicillin and Viagra. She went a step further and even called the claims of the suit extremely weak.
At the same time as this, abortion advocates are also calling for the FDA to lift restrictions on the drug swiftly. 9 Democratic Senators have already written to FDA Commissioner Robert M. Califf calling for changes that would increase access to the drug.
Also read, California Files Suit Against Several PBMs Over High Insulin Costs
