Anti-abortion group asks Supreme Court to keep mifepristone restrictions

An anti-abortion group on Tuesday asked the Supreme Court to keep restrictions on the abortion pill mifepristone in place while the battle over the medication’s legal status plays out.

Supreme Court Justice Samuel Alito on Friday temporarily blocked those restrictions until 11:59 p.m. ET Wednesday in response to an emergency request from the Justice Department and Danco Laboratories, the company that distributes mifepristone.

The Justice Department and Danco also asked the Supreme Court to review the case on an expedited schedule and make a judgement before its summer recess. The high court, which has a 6-3 conservative majority, could decide at any time how to proceed with the case.

The group, the Alliance Defending Freedom, asked the Supreme Court, should the justices decide to take the case, to look into whether an 1873 law called the Comstock Act bans mail delivery of mifepristone. The anti-abortion organization also said that the court should consider whether the FDA properly approved mifepristone in 2000 if it takes the case.

Mifepristone, used in combination with a drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions. If the lower court rulings against mifepristone ultimately stand, access to abortion could face restrictions even in some states where the procedure remains legal.

Attorneys with the Alliance Defending Freedom accused the FDA of illegally rolling back restrictions on mifepristone over the years. The organization represents a coalition of doctors who oppose abortion called the Alliance for Hippocratic Medicine.

Former FDA officials, the pharmaceutical industry, 23 U.S. states, hundreds of members of Congress and leading medical associations all strongly dispute those claims. They say the FDA determined mifepristone was safe and effective based on a rigorous scientific review, and its decision regulating the medication falls well within its authority granted by Congress.

The former FDA officials and a coalition of drug companies that include Pfizer, in a separate briefs to the Supreme Court, warned that the lower court rulings restricting mifepristone would deliver a severe blow to the FDA’s regulatory powers and chill research, development and investment in new medications.

Federal Judge Matthew Kacsmaryk of the U.S. Northern District of Texas earlier this month suspended the FDA’s approval of mifepristone and every subsequent action the agency had taken to ease access to the medication.

The U.S. 5th Circuit Court of Appeals blocked part of Kacsmaryk’s order and kept the FDA approval in place, but re-imposed restrictions on how mifepristone is used and distributed.

The appeals blocked mail delivery of mifepristone, required patients to visit a doctor to obtain the medication, and shortened the timeframe when women can take the drug to the seventh week of pregnancy. They also blocked the 2019 approval of the generic version of mifepristone distributed by another company called GenBioPro.

Alito hit pause on those lower court decisions and has allowed mifepristone to remain more broadly available for now.

“Women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use,” argued the Alliance Defending Freedom’s attorneys, led by Erik Baptist. “The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician.”

But the Justice Department and Danco, in their emergency requests to the Supreme Court, said the lower court rulings would effectively take mifepristone off the market for months as the FDA adjusts the medication’s labelling to comply with the 5th Circuit’s decision.

U.S. Solicitor General Elizabeth Prelogar said the litigation and lower court rulings have been “troubling at every level” and would have sweeping consequences for the pharmaceutical industry, women’s health and the FDA’s drug approval powers.

The government also argued that complying with the appeals court ruling would effectively but in violation by of a competing court order by Judge Thomas Rice of the U.S. Eastern District of Washington. Rice has barred the FDA from restricting the availability of mifepristone in 17 states and Washington, D.C.