Justice Department appeals to Supreme Court, asks justices to restore broad availability of abortion pill mifepristone

By Dave Andrusko

Earlier today, the Biden Department of Justice asked the Supreme Court to allow full access to mifepristone, the first of two drugs that make up chemical abortions which is used in over half of the abortions in the United States.

“Justice Department lawyers and the drug company asked the justices to temporarilyblock the decision last week from a federal judge [Judge Kacsmaryk] in Texas who suspended approval of the drug or to quickly schedule briefing and oral argument to review the case before the court’s term ends this summer,” the Washington Post reported.

Solicitor General Elizabeth B. Prelogar told the court in the government’s filing, “If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”

A week ago in a much anticipated decision, U.S. District Judge Matthew J. Kacsmaryk ruled that the FDA’s approval of mifepristone should be enjoined. He issued a one week temporary stay to allow the government to appeal. Within hours, the Biden administration did so. On Monday the Justice Department appealed to the 5th circuit and subsequently to the Supreme Court.

The lawsuit before Judge Kacsmaryk struck the FDA’s lackadaisical approach to mifepristone at its most vulnerable points, beginning with an abysmal failure to address legitimate questions in a timely fashion. In the very first paragraph, he wrote

Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion. The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition. ”But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.

On Wednesday a three-judge panel of the 5th Circuit Court of Appeals granted a partial stay, pending appeal, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The 5th Circuit keeps in place the portion of Judge Kacsmaryk’s order requiring the FDA to restore previous safeguards for chemical abortion drugs.

The 5th Circuit decision would remove the changes made in 2016, 2021, and 2023 which loosened the FDA’s original safeguards applied to mifepristone. It leaves in place the original requirements that the drug be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.

However the 5th Circuit panel refused—for now—to undo the FDA’s approval of mifepristone in 2000.

According to the Washington Post’s Robert Barnes, the “justices have several options.”

“They could allow the lower-court ruling to take effect while the appellate courts play their normal roles in reviewing the merits of district court decisions. But abortion providers and the Biden administration say that would create chaos because of the conflicting rulings.”

Or the court could stay the rulings to maintain the status quo.

On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).

Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here