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Justice Dept, drug maker ask Supreme Court to intervene in abortion pill ruling

ByTeam BB

Apr 14, 2023


Washington — The Justice Department and a pharmaceutical company that makes the abortion pill mifepristone have asked the Supreme Court to step into the legal battle involving the drug after an appeals court issued a decision that preserved access to it but blocked a number of moves by the Food and Drug Administration (FDA) that expanded its availability.

In separate requests for emergency relief, the Justice Department and Danco Laboratories, the maker of mifepristone, asked the high court to put on hold the full decision from U.S. District Judge Matthew Kacsmaryk, which halted the FDA’s 2000 approval of the medication and subsequent actions by the agency that made it easier to access.

“The district court countermanded a scientific judgment FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” the Justice Department wrote to the court.

Solicitor General Elizabeth Prelogar asked the high court to put the district court’s decision, issued one week ago, on ice while proceedings in the U.S. Court of Appeals for the 5th Circuit continue. She also asked the court to issue an immediate administrative stay to preserve mifepristone’s availability while it considers the Biden administration’s request.

If the Supreme Court declines to block the decision from the Texas judge, Prelogar suggested the court swiftly agree to take up the dispute and schedule briefing and oral argument, allowing it to review and decide the case before its term ends this summer.

“The abrupt shift in the regulatory landscape that would be required by the lower courts’ orders raises a host of unprecedented issues and has put FDA and regulated entities in an impossible position,” the Justice Department said.

The dispute arrived at the Supreme Court after the 5th Circuit late Wednesday halted Kacsmaryk’s decision that blocked the FDA’s approval of the mifepristone. But it left in place part of the district court’s order that blocked changes made by the FDA beginning in 2016, tightening rules surrounding the most common method of terminating an early pregnancy.

The changes made by the FDA regarding mifepristone included extending the gestational limit for the drug’s use from seven weeks to 10 weeks of pregnancy, reducing the number of required in-person clinic visits and broadening the set of health care providers allowed to prescribe the drug.

The FDA also approved a generic version of mifepristone in 2019 and lifted a requirement that the pills be dispensed in-person in 2021, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail.

In its separate request for relief, Danco said the 5th Circuit’s “unprecedented order has created regulatory chaos across the country.”

The decision by the Biden administration to seek emergency relief from the Supreme Court was not unexpected — it said in filings to the 5th Circuit that it would turn to the high court if necessary — and is the latest move in its swift legal response to the decision from Kacsmaryk. President Biden has vowed to protect abortion access, and White House press secretary Karine Jean-Pierre told reporters the administration “will prevail because we believe that the law is on our side.”

“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement Thursday, before the Justice Department formally made its request. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

The case, known as Alliance for Hippocratic Medicine v. FDA, is the most significant involving abortion rights to land before the Supreme Court since it ended the constitutional right to abortion by overturning Roe v. Wade last year. That decision paved the way for a dozen states to enact near-total bans on the procedure, while more have imposed new laws restricting the ability to obtain abortion care.

But the district court’s order and subsequent decision from the 5th Circuit conflict with a different ruling from a federal judge in Washington state. That decision ordered the FDA to maintain the status quo with regard to mifepristone’s availability in 16 states and the District of Columbia. Those states and D.C. sued the Biden administration in February over a set of restrictions imposed on the drug and sought to preserve access to it.

The competing orders only inject further chaos and confusion into a legal landscape upended by the Supreme Court’s reversal of Roe.

Referencing the turmoil that has followed the conflicting court orders regarding mifepristone, Danco said the “result is an untenable limbo, for Danco, for providers, for women, and for health care systems all trying to navigate these uncharted waters-and all after plaintiffs waited years and years before claiming irreparable injury and a need for an emergency injunction voiding the decades-long status quo.”

The challenge to mifepristone’s FDA approval is the latest effort from anti-abortion rights advocates to curtail abortion access. The lawsuit was brought by a conservative legal organization on behalf of the physicians and medical associations in federal court in Amarillo, Texas, where only Kacsmaryk hears cases.

Lawyers for the challengers argued the FDA erred in determining mifepristone’s safety and effectiveness, and claimed the agency exceeded its regulatory authority in approving the drug more than 20 years ago. 

But the FDA has stressed that serious adverse events are exceedingly rare when mifepristone is used as the agency directs and noted that more than 5 million women have taken the medication since 2000. Only 28 deaths were reported through June 2022, some of which were associated with “obvious alternative causes” unrelated to use of the abortion pill, the agency said.

Medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention. Mifepristone is taken together with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.

With access to mifepristone at risk, Democratic-led states have moved to beef up their supplies of the drug and misoprostol, which can be taken on its own to terminate an early pregnancy. But a misoprostol-only medication abortion is slightly less effective — between 80% and 99% — than the two-drug regimen of mifepristone and misoprostol, which is between 95% and 99% effective. 

California Gov. Gavin Newsom announced Monday that the state secured an emergency stockpile of up to 2 million misoprostol pills. Massachusetts Gov. Maura Healey directed health care providers in the state to bank more doses of mifepristone. The University of Massachusetts Amherst purchased roughly 15,000 doses, enough to last the state more than a year, and the doses are set to arrive this week. New York Gov. Kathy Hochul said Tuesday that her state would stockpile 150,000 doses of misoprostol.


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