A Christian organization argued before a conservative federal judge in Texas on Wednesday in a lawsuit that might jeopardize the most popular type of abortion in the country by challenging the Food and Drug Administration’s more than 20-year-old clearance of an abortion drug.
During the hearing in Amarillo, Texas, attorneys for the Alliance for Defending Freedom requested that Judge Matthew Kacsmaryk issue an urgent order revoking or suspending the approval of the medicine mifepristone. Such a move would be an unprecedented challenge to the FDA, which in 2000 approved the use of the combination of mifepristone plus a second tablet as a safe and effective way to stop pregnancy.
Alliance attorney Erik Baptist gave a 90-minute presentation to the court, arguing that taking mifepristone off the market “would restore proper policing power to the states”—a reference to the U.S. Supreme Court decision last summer that overturned Roe v. Wade and gave states the authority to decide whether or not abortion is legal.
Since Roe was overruled, mifepristone, when taken with a second pill, has emerged as the most popular form of abortion in the United States.
Kacsmaryk, who was chosen by then-President Donald Trump, acknowledged the importance of the case and questioned Baptist about a previous instance of a court pulling an FDA-approved medicine off the market after many years.
Although Baptist recognized that there are no precedents, he attributed the medicine’s continued use to the FDA’s “stonewalling” of earlier petitions from his group to have the drug removed. In an effort to limit access to the medication, the group petitioned the FDA in 2002 and again in 2019.
The FDA’s legal team is anticipated to contend that discontinuing mifepristone will drastically alter reproductive healthcare for American women and jeopardize the government’s scientific oversight of prescription pharmaceuticals.
In the crucial case, Kacsmaryk permitted both sides two hours to present their reasons with opportunity for reply. Danco Laboratories, the producer of mifepristone, will support the FDA’s case to keep the medication available.
Any moment after the debates are over, a decision could be made. The FDA’s legal counsel at the U.S. Department of Justice would promptly appeal a negative ruling and probably ask for an emergency stay to prevent the medicine from going into force while the issue is being litigated.
The FDA’s abuse of power in initially approving the drug is one of the alliance’s main criticisms of the agency.
The FDA examined the drug as part of its so-called fast approval program, which was established at the beginning of the 1990s to hasten the availability of the first HIV medications. It has since been utilized to speed up the development of medications for cancer and other “severe or life-threatening disorders.”
The alliance contends that because pregnancy is not an illness, mifepristone should not have been given speedy approval. The alliance was also a part of the litigation that caused the Supreme Court to reverse Roe.
“The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be starker,” Baptist told Kacsmaryk.
