Court seems skeptical of FDA approval and regulation of pill

A federal appeals court on Wednesday appeared prepared to rule that the availability of a commonly used abortion pill should be curtailed, showing skepticism of the decisions that the Food and Drug Administration has made about the drug.

At issue is whether to uphold a preliminary ruling from a federal judge in Texas, who declared in April that the FDA’S 23-year- old approval of the pill, mifepristone, was invalid.

From the outset of the two-hour hearing in New Orleans, questions and comments fromthree judges on the 5th U.S. Circuit Court of Appeals reflected criticism of the FDA and a lack of familiarity with medication abortion, particularly how it is prescribed.

The arguments included whether the parties that brought the lawsuit — four anti-abortion doctors and an umbrella group called the Alliance for Hippocratic Medicine — could show they would suffer actual harmif themedication continued to be available and whether they waited too long to challenge the approval of mifepristone, the first pill in a two- drug regimen.

The plaintiffs claim that mifepristone is unsafe, that the FDA did not follow proper regulatory protocols in approving it in 2000 and that the agency has inappropriately eased restrictions on the pill since then. The government strongly disputes those contentions, citing years of research that mifepristone is safe and arguing that the agency has acted responsibly.

In the hearing, Sarah Harrington, the Justice Department lawyer representing the FDA, and Jessica Ellsworth, a lawyer for amanufacturer ofmifepristone, Danco Laboratories, said that the doctors who are plaintiffs cited no examples of cases in which they were compelled to provide treatment for patients who experienced complications from medication abortion.

A lawyer for the plaintiffs, Erin Hawley, said that the anti- abortion doctors have been harmed in a way that qualifies them to file suit.

They “are not alleging harm because they’re forced to provide an abortion,” she said, adding: “Their conscience harm is much broader. They allege that they feel complicit in an elective abortion by being forced to complete that procedure.”