The Mifeprex pill is one drug that terminates pregnancy up to the seventh week of gestation. A federal lawsuit in Texas could halt nationwide distribution of mifepristone -- a similar abortion drug that has been used for decades to terminate early pregnancies. File photo by Bill Grenblatt / UPI | License Photo
March 15 (UPI) -- A lawsuit being argued before a federal judge in Texas Wednesday could halt nationwide distribution of a popular but controversial abortion drug that has been used for decades to terminate early pregnancies.
Arguments open Wednesday before U.S. District Judge Matthew Kacsmaryk several months after conservatives filed the legal action in November to ban mifepristone -- an FDA-approved drug -- on behalf of several anti-abortion medical groups.
The lawsuit seeks a preliminary injunction that would rescind the government's approval for the medication which was granted by Food and Drug Administration 23 years ago under the Clinton administration.
The suit claims the agency overstepped its authority and fast-tracked the drug even though the treatment did not qualify for an accelerated federal rollout like those given in cases of "serious or life-threatening illnesses."
In court papers, anti-abortion lawyers argue that early-stage pregnancy is neither an "illness" nor a condition that is "serious or life-threatening."
The lawsuit also argues the FDA had removed consumer safety protections that led to weaker dosage and distribution requirements.
"The FDA took these actions by running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs," attorneys for the plaintiffs argued.
The Biden administration has described the lawsuit against the FDA as "extraordinary and unprecedented," saying the case has the potential to "seismically disrupt the agency's governing authority as to whether drugs are safe and effective."
It was also the first time in recent memory that a legal case had "second-guessed FDA's safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market -- much less an example that includes a two-decade delay," the government said in papers filed with the court.
Justice Department lawyers intend to argue that reversing access to the drug would hurt patients who depend on it for extensive medical reasons -- not exclusively abortions -- and would put more pressure on state health systems to provide necessary care with increasing health restrictions in place following the Supreme Court repeal of Roe vs. Wade last June, which barred the constitutional right to an abortion.
Government attorneys have also noted that mifepristone wasn't approved until four years after Danco submitted a federal application to manufacture the drug.
Lawyers for both sides will be given two hours to lay out their cases before the judge, who issued an order earlier this week for the parties to come to court prepared to discuss the legal standing of the suit and whether an injunction was in the public interest.
It was unclear when the judge will issue the ruling, which both sides have the ability to appeal to the 5th U.S. Circuit Court of Appeals.
Since the Supreme Court ruling, nearly two dozen GOP-led states have enacted abortion bans and restrictions, while at least 14 legislatures across the country have also placed limits on abortion medications. The procedure, however, remains legal in many other states that have not moved to change existing laws.
Mifepristone blocks a hormone that allows a pregnancy to develop, and its use accounts for more than half of all abortions in the United States.
Opponents argue the drug is a form of "chemical abortion," claiming the pills, which haven't been adequately researched, were known to cause "cramping, heavy bleeding and severe pain."