A federal appeals court on Wednesday upheld parts of a decision limiting access to a widely used abortion pill, but the ruling will have no immediate impact on the availability of the drug, mifepristone.
In their ruling, a three-judge panel on the conservative-leaning U.S. 5th Circuit Court of Appeals held that the Food and Drug Administration failed to adequately take into account safety concerns when it loosened access to mifepristone in 2016.
While the ruling is a victory for abortion opponents, the Justice Department is expected to appeal the decision and the Supreme Court earlier this year issued a stay while the case goes through the appeals process. That temporary pause has allowed the drug to remain widely available.
The FDA-approved regimen for a medication abortion involves a combination of two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions. A majority of abortions in the U.S. are carried out with the use of these pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.
The case originated in Texas, where U.S. District Judge Matthew Kacsmaryk ruled in favor of a group of doctors and medical professionals who oppose abortion and were challenging the FDA’s approval of mifepristone, as well as later regulatory changes that made the drug more available.
One, in 2016, extended the window in which mifepristone could be used to terminate pregnancies from seven weeks gestation to 10 weeks and reduced the number of in-person visits that patients were required to make from three to one. Another in 2019 approved a generic form of the drug, and another in 2021 removed a requirement that mifepristone be dispensed only in clinics, medical offices and hospitals, thereby allowing the drug to be administered via telehealth and sent by mail.
Kacsmaryk, a Trump appointee, issued a ruling suspending the FDA’s 2000 approval of mifepristone, citing in part what he called “evidence indicating FDA faced significant political pressure” to approve the drug more than two decades ago.
The Justice Department then filed an emergency appeal of Kacsmaryk’s order to the 5th Circuit, arguing the ruling “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
In their ruling Wednesday, the three-judge panel, comprised of two Trump appointees and one George W. Bush appointee, found that the groups and doctors that sued waited too long to challenge the original 2000 approval of mifepristone, but the post-2016 ways the FDA made the pill easier to get should be put on hold because those moves “were taken without sufficient consideration of the effects those changes would have on patients.”
In a statement, Evan Masingill, the CEO of GenBioPro, the manufacturer of generic mifepristone, said despite the ruling, the drug “remains lawful and available on the market. We remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the US Food and Drug Administration’s regulatory authority.”
Alexis McGill Johnson, president of Planned Parenthood Federation of America, said the ruling “makes it clear that mifepristone’s approval is very much still at risk, as is the FDA’s independence.”
Katie Daniel, state policy director of Susan B. Anthony Pro-Life America, a leading anti-abortion group, hailed the ruling.
“The FDA ignored science and its own rules when it rubber-stamped Democrats’ reckless mail-order abortion scheme,” she said. “We won’t rest until the FDA and the profit-driven abortion industry are held accountable for the suffering they’ve inflicted on women and girls, as well as the deaths of countless unborn children.”
Source: | This article originally belongs to Nbcnews.com
