Two federal district judges issued dueling opinions Friday over the Food and Drug Administration’s approval and regulation of an abortion medication more than 20 years ago, adding confusion to a growing morass of abortion-related litigation resulting from last year’s Supreme Court decision overturning Roe v. Wade.
In Texas, Judge Matthew Kacsmaryk, in a 67-page ruling, wrote that the FDA “exceeded its authority” in approving mifepristone, saying the agency used an accelerated approval process meant for drugs intended to treat “life-threatening diseases” and because the drug does not provide a “meaningful therapeutic benefit” for patients.
“The error in FDA’s judgment is borne out by myriad stories and studies brought to the Court’s attention,” he wrote, adding “a preliminary injunction would serve the public interest.”
The injunction will take effect in seven days, which Kacsmaryk said would give the federal government time to seek emergency relief from the 5th Circuit Court of Appeals. It follows a March 15 hearing on the case.
Shortly after that ruling, U.S. District Judge Thomas Rice in the Eastern District of Washington state ruled that the FDA should not change the status quo related to mifepristone.
However, that ruling would only apply to the 17 states and Washington, D.C., plaintiffs in the lawsuit aimed at expanding and protecting mifepristone access.
The litigation adds to growing confusion over state and federal abortion restrictions. Survey results from the nonpartisan Kaiser Family Foundation released Feb. 1 found that about half of adults were unsure if mifepristone was legal in their state — and 13 percent in states with abortion bans incorrectly believed the drug was legal in their state.
Mifepristone, which is used to end pregnancy and can be taken by a patient outside a doctor’s office or clinical setting, has faced pushback from abortion opponents and tighter regulations than most other medications since the FDA approved it in 2000. Taken in a regimen with misoprostol, mifepristone can be used to end a pregnancy but is also prescribed for miscarriage management and for other medical uses.
Kacsmaryk’s decision would block the FDA’s approval of mifepristone as well as subsequent changes in 2016, 2019 and 2021.
“Unlike abortionists suing on behalf of women seeking abortions, here there are no potential conflicts of interest between the Plaintiff physicians and their patients,” wrote Kacsmaryk, an appointee of former President Donald Trump.
Requests for mail-order abortions increased in every state after the Dobbs v. Jackson Women’s Health Organization decision last year, with the biggest increases in states with total abortion bans, according to research published in November 2022 in the Journal of the American Medical Association.
Kacsmaryk’s ruling, though possibly temporary, is a huge win for abortion opponents following two Biden administration actions in January to expand mifepristone access, including across state lines, and is more impactful because of its potential nationwide impact. The Justice Department is expected to appeal the decision to the U.S. Court of Appeals for the 5th Circuit, which has previously ruled against abortion rights and aspects of the 2010 health law (PL 111-148PL 111-152).
In November, Alliance Defending Freedom, a conservative legal advocacy group, challenged the FDA’s 2000 approval of the drug, citing concerns from anti-abortion medical groups about mifepristone’s safety and seeking an emergency ruling to pull approval of the drug nationwide.
ADF is representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical and Dental Associations and four doctors in the suit. ADF filed its brief Feb. 10, and the Justice Department submitted its own brief on Jan. 13.
ADF senior counsel Erik Baptist, speaking to the press on March 16, said blocking FDA’s approval of mifepristone would not affect other uses of the drug, such as as mifepristone branded as Korlym used to treat Cushing’s syndrome.
“Patients who need that medication will be absolutely able to obtain that drug because it’s made by a different manufacturer whose drug approval is not an issue in this case,” Baptist said.
He also pushed back on the notion that a court overturning FDA’s approval of a drug would set a new precedent.
“I’m not aware of a situation where the FDA has stonewalled a citizen petitioner for almost two decades, letting that drug come to the marketplace while there were significant legal and medical concerns about that approval in the first place. It essentially evaded judicial review until now,” he said.
“Pregnancy is not an illness, but that’s what the FDA had characterized it in order to approve this drug in the first place,” he said. “This lawsuit will not jeopardize the approvals of other drugs because this was so out of balance by the FDA.” The two companies that produce mifepristone domestically — Danco Laboratories and GenBioPro — have criticized the lawsuit.
In January, Danco Laboratories filed an ultimately successful motion to intervene in the case, while GenBioPro filed a separate lawsuit in West Virginia challenging state restrictions on medication abortions.
Abortion rights supporters point to previous oversight into the safety of mifepristone that did not cite concerns with its approval — including a 2016 review by the FDA’s Center for Drug Evaluation and Research and a 2018 report from the Government Accountability Office that said the agency used its standard review process in approving the drug and any labeling changes.
In January, FDA eased restrictions on dispensing mifepristone — allowing retail pharmacies for the first time to seek certification to sell the drug where permitted under state law. The nation’s largest pharmacy chains — Walgreens, CVS and Rite Aid — subsequently announced they plan to seek certification in some of their locations where it remains legal.
Abortion opponents called for boycotts and started petitions against the pharmacies’ decisions, and a coalition of 20 Republican attorneys general warned pharmacies against selling the drug in their states.
In March, a Walgreens spokesperson confirmed in response to the letter that the chain would not be dispensing mifepristone in those respective states but intends to become a certified pharmacy to distribute the drug in states where it is “legal and operationally feasible.” California Gov. Gavin Newsom subsequently announced the state would not renew its contract with Walgreens.
Republican state officials and federal lawmakers have also called for the FDA to modify or pull approval of mifepristone. In January, 22 state Republican attorneys general wrote to FDA blasting the change to loosen restrictions.
South Dakota Gov. Kristi Noem and state Attorney General Marty Jackley warned pharmacists in a Jan. 24 letter that mifepristone is illegal to dispense under state law. In March, Wyoming became the first state to enact a law banning the use or prescribing of mifepristone.
Sen. Cindy Hyde-Smith, R-Miss., and Rep. Bob Latta, R-Ohio, have introduced a bill (S 95, HR 427) that would rescind FDA approval of mifepristone and led a letter to FDA Commissioner Robert Califf also asking for FDA to act.
Rep. Diana Harshbarger, R-Tenn., and Republican Study Committee Chairman Kevin Hern of Oklahoma also introduced a bill (HR 383) in January that would roll back FDA’s most recent changes to mifepristone.
Impact
Sales and distribution of the drug would halt under an injunction. But it’s unclear whether existing supplies of mifepristone would be destroyed if the drug’s authorization is ultimately revoked, given the unprecedented nature of the case.
“This type of preliminary injunction blocking an FDA approved drug that has been on the market for over 20 years has never happened before,” said Laurie Sobel, associate director of women’s health policy at the Kaiser Family Foundation.
Even before the Texas ruling, the White House and state officials were planning their response.
“We have been talking internally, how we would move forward, if this unprecedented action is taken,” said White House Press Secretary Karine Jean-Pierre during an April 5 press briefing. “We’re going to prepare for all the different range of scenarios.”
Washington state began stockpiling its supply of mifepristone ahead of a possible Texas ruling. The state invested $1,275,000 to purchase a three-year supply — about 30,000 doses of mifepristone — using existing statutory authority through the Washington Department of Corrections, a move that Gov. Jay Inslee, a Democrat, called “an insurance policy.”
But Jennifer Dalven, director of the American Civil Liberties Union’s Reproductive Freedom Project, said on an April 5 press call, “It’s not at all clear that states will have the capacity to protect this drug.”
Abortion providers have been bracing for the impact of a ruling with nationwide implications.
Some clinics have already signaled they plan to switch to only surgical abortions or are considering misoprostol-only regimens. Misoprostol is not subject to the same safety restrictions as mifepristone.
Misoprostol is also prescribed to prevent stomach ulcers, induce labor and treat postpartum bleeding. It can also be used alone at higher doses for a medication abortion.
“Each of our affiliates will have to decide what their options are,” said Bhavik Kumar, medical director for primary and transgender care at Planned Parenthood Gulf Coast during an April 5 press call.
Lauren Clason contributed.
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