Abortion pill could be pulled off market by Texas lawsuit
>> A Texas lawsuit with a key deadline this month is posing a threat to the nationwide availability of medication abortions, which now accounts for the majority of abortions in the U.S.
The case filed by abortion opponents who helped challenge Roe v. Wade seeks to reverse a decadesold approval by the Food and Drug Administration.
If a federal judge appointed by former President Donald Trump sides with them, it could halt the supply of the drug mifepristone in all states, both where abortion is banned and where it remains legal.
“It could have an immediate impact on the country,” said Mini Timmaraju, president of NARAL ProChoice America. “In some ways this is a backdoor ban on abortion.”
On Friday, a group of 22 Democratic-led states weighed in, saying the consequences of reversing the approval could be “nothing short of catastrophic. A similar-sized group of Republican states also filed briefs supporting the reversal, saying the ability to order pills by mail undermines their laws banning abortion.
U.S. District Judge Matthew Kacsmaryk has not indicated exactly when or how he will rule, but groups like Timmaraju's have been preparing for a possible decision shortly after a Feb. 24 filing deadline. There is scant precedent for a lone judge overruling the FDA's scientific decisions. A swift appeal of any ruling is likely.
The lawsuit was filed by the group Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned.
“Our representatives in Congress created the FDA and gave the FDA the responsibility to make sure that drugs are safe before they're allowed on the market … the FDA failed that responsibility,” said Julie Blake, senior counsel for the group.
They argue the FDA overstepped its authority in approving mifepristone by using an accelerated review process reserved for drugs to treat “serious or life-threatening illnesses.”
But in its legal response, the agency said it didn't accelerate the drug's approval, which came four years after the manufacturer first submitted its application to market the pill.
The FDA approved mifepristone — in combination with a second drug — as a safe and effective method for ending a pregnancy in 2000. Common side effects include cramping and light bleeding. Cases of more severe bleeding requiring emergency care are very rare.
Halting access to the drug more than 20 years after approval would be “extraordinary and unprecedented,” federal attorneys stated in a legal filing.
Kacsmaryk, who previously ruled against a program providing free birth control to minors in Texas, could also issue a ruling rolling back regulators' decisions to ease restrictions on the pill's availability. Those have been based on scientific studies showing women can safely use the drug at home.
In late 2021, the FDA removed a requirement that women pick up the drug in person. Last month the agency dropped another requirement that prevented most pharmacies from dispensing the pill.