Democrats fight back after Texas abortion pill ruling

Democrats in the House of Representatives will introduce a bill today that seeks to reaffirm the authority of the FDA on drug approvals, after a Texas court held that the regulator had rushed the abortion pill mifepristone to market.

US District Judge Matthew Kacsmaryk said in the ruling that there should be a stay on the prescribing and distribution of mifepristone from Friday, overturning more than two decades of use of the drug alongside misoprostol to terminate pregnancies.

The decision follows the controversial elimination of the constitutional right to abortion in the US last June and is the first time a judge has suspended FDA approval of a medication, despite opposition from the regulator and the drug’s manufacturer.

“The court does not second-guess FDA’s decision-making lightly,” said the ruling. “But here, FDA acquiesced on its legitimate safety concerns – in violation of its statutory duty – based on plainly unsound reasoning and studies that did not support its conclusions.”

The Texas decision came alongside a ruling in Washington state by Judge Thomas Rice, which ruled that mifepristone is safe and effective and ordered the FDA to retain access to the drug in 17 US states.

The Department of Justice lost no time in filing an appeal against the Texas verdict, seeking to preserve access to mifepristone while the next legal round in the Court of Appeals for the 5th Circuit plays out. Danco Labs, which manufactures mifepristone, has also filed an appeal, as has the FDA.

Democrat Reps Pat Ryan (D-NY) and Lizzie Fletcher (D-Texas), meanwhile, have responded by tabling a bill that seeks to clarify that the FDA has the final say on regulatory approvals, and supersedes state law on medication abortion, as well as the prescription of pharmacological abortifacients via telemedicine.

The bill will have a tough time getting through the Republican-controlled House, so is largely a symbolic gesture, though also a sign of the mobilisation of the party to try to protect the FDA’s authority.

“The Texas decision has nothing to do with science or medicine and everything to do with radical groups whose only goal is a national abortion ban,” said Rep Ryan, while Fletcher remarked that the decision “if enforced, would be devastating to women and families across our country and to our established drug-approval system.”

For its part, the FDA said in a statement that it “stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses.”