The FDA’s safety limits on the abortion pill will remain in place at least temporarily in 17 states and Washington, D.C., while a federal judge in Washington state considers a final decision on a Democratic state-led challenge to the restrictions.
(Bloomberg Law) — The FDA’s safety limits on the abortion pill will remain in place at least temporarily in 17 states and Washington, D.C., while a federal judge in Washington state considers a final decision on a Democratic state-led challenge to the restrictions.
Judge Thomas O. Rice of the US District Court for the Eastern District of Washington ruled Friday that it was unclear whether the states, led by Washington Attorney General Bob Ferguson (D), are likely to succeed in arguing that the Food and Drug Administration’s restrictions on mifepristone are overly burdensome and not based in science.
The ruling marks a blow to abortion advocates who have called on the Biden administration to defend access to the pill amid state abortion bans and other restrictions after the Supreme Court overturned the constitutional right to an abortion.
Texas Ruling
The FDA’s restrictions, called a risk evaluation and mitigation strategy, include requirements that health-care providers and pharmacies be certified to prescribe the pill and dispense the pill, respectively. Several doctors and physician groups, as well as abortion access advocates, have said existing evidence defending the pill’s safety and efficacy make the limits on mifepristone unnecessary.
Democratic state attorneys general argued in their complaint in February that the REMS program “only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense.”
Meanwhile, a federal judge in Texas overturned the FDA’s decades-long approval of mifepristone.
GenBioPro, maker of generic mifepristone, will keep its product available while reviewing the order, said company CEO Evan Masingill in a statement.
“We will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible in the country,” Masingill said.
Legal experts and stakeholders are still reviewing the judge’s impact on the case.
Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University, noted that while the Texas judge can issue a nationwide block on mifeprstone, the Washington case marks a split, meaning the case would likely “go straight up to appeal.”
From there, the U.S. Court of Appeals for the Fifth Circuit—widely believed to be amongst the most conservative courts in the country—would likely issue a stay on the Texas decision.
Still, Maggie Jo Buchanan, senior director and senior legal fellow for the Women’s Initiative at American Progress, said there remains “little clarity on exactly what may exactly happen next.”
“The contradictory orders do make it likely that the Supreme Court will be asked to rule on mifepristone even sooner than expected,” Buchanan said.
The Texas case sits before Judge Matthew Kacsmaryk, a Trump appointee who has already issued decisions against Biden administration policies on immigrant, reproductive, and LGBTQ rights. Attorneys and policy analysts warned that a decision in the abortion pill case could have lasting impacts on the FDA’s authority in measuring a drug’s safety and efficacy.
Kacsmaryk’s order, however, won’t go into effect for seven days.
In the short term, that means “everything stays the same,” said Greer Donley, a law professor at the University of Pittsburgh. That said, if the Fifth Circuit doesn’t change course in that time period, “mifepristone will become an unapproved drug in this country.”
If that happens, however, the FDA could use its “enforcement discretion” to decline “going after” anyone selling the unapproved drug, Donley said. That means that even if selling mifepristone is illegal, there would be a safe harbor for people violating the law.
The case is Washington v. FDA, E.D. Wash., No. 1:23-cv-03026, 4/7/23.
To contact the reporters on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com; Ian Lopez in Washington at ilopez@bloomberglaw.com
To contact the editors responsible for this story: Karl Hardy at khardy@bloomberglaw.com; Maya Earls at mearls@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com; Brent Bierman at bbierman@bloomberglaw.com
(Updated reporting throughout. An earlier update added reference to Texas case.)
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