Topline
The Justice Department will ask the Supreme Court to intervene in the battle over the abortion pill mifepristone, as the federal government tries to maintain the FDA’s approval of the drug following court decisions in Texas that would partially reverse it.
U.S. Attorney General Merrick Garland
Key Facts
Attorney General Merrick Garland said the Justice Department will ask the Supreme Court for emergency relief after a Texas appeals court on Wednesday limited access to mifepristone, partially siding with anti-abortion activists who brought a lawsuit challenging the FDA’s approval of the drug.
The Justice Department “strongly disagrees with the Fifth Circuit’s decision,” Attorney General Merrick Garland said in a statement on Thursday.
The U.S. Court of Appeals for the Fifth Circuit on Wednesday blocked the loosened restrictions for the drug implemented by the FDA in 2016, meaning pregnant people cannot take mifepristone past the first seven weeks of pregnancy and must have three in-person doctor visits before the drug is administered.
The appeals court temporarily put on hold a controversial ruling by U.S. District Judge Matthew Kacsmaryk that would have suspended the FDA’s approval of the drug starting Friday, giving the Biden Administration more time to appeal Kacsmaryk’s decision.
Key Background
Anti-abortion activists filed a lawsuit in Texas federal court in November that asked a judge to reverse the FDA’s approval of mifepristone, claiming that the agency ignored safety concerns in approving the drug in 2000. Kacsmaryk, who was appointed by former President Donald Trump in 2019, sided with the groups in ruling on Friday that the FDA “acquiesced on its legitimate safety concerns,” though he suspended the agency’s approval, rather than tossing it out completely, as the plaintiffs’ requested. Kacsmaryk’s ruling could force the FDA to withdraw its approval and be forced to put future decisions that could expand the drug’s access on hold, the New York Times reported, noting that the drug could still be available during the lengthy FDA withdrawal process.
Surprising Fact
The case could compromise the drug’s usage for other gynecological conditions, including miscarriages and early pregnancy loss, experts told Forbes. Mifepristone is also used as a treatment for the rare endocrine disease, Cushing’s syndrome, though it’s marketed as a separate drug in those circumstances and the case is not expected to impact Cushing’s patients, Leslie Edwin, the president of the Cushing’s Support and Research Foundation, told Forbes.
Contra
Democratic states and lawmakers have taken efforts to expand access to abortion pills in the wake of Kacsmaryk’s decision. House Democrats introduced legislation Monday that would reiterate the FDA’s authority to approve abortion medication and allow doctors to continue prescribing the drugs via telehealth conference. California Gov. Gavin Newsom (D) also announced plans to stockpile an emergency supply of the abortion pill misoprostol, which is used in conjunction with mifepristone.
Further Reading
Abortion Pill Mifepristone Won’t Lose Approval—At Least For Now—As Appeals Court Partially Blocks Controversial Ruling (Forbes)
California Stocks Up On Abortion Pill Misoprostol As Judge Seeks To Block Another Drug (Forbes)
Mifepristone Ruling: Here Are The Unintended Health Consequences Of Attacks On Abortion Pills (Forbes)
House Democrats Unveil Bill To Fight Texas Ruling That Would Limit Abortion Pill Access (Forbes)
Source: https://www.forbes.com/sites/saradorn/2023/04/13/justice-department-asks-supreme-court-to-reverse-abortion-pill-limitations/