Abortion doctors are having a grand ol’ time asking the Supreme Court to reinstate a lower court decision that suspended government approval of a medication used in more than half of pregnancy terminations in the United States. These doctors are saying the Food and Drug Administration has “stripped away every meaningful and necessary safeguard on chemical abortion.” Oh dear, how unsafe.
The Alliance for Hippocratic Medicine, which sounds like a fancy name for a medical school for horses, told the justices that they should leave in place lower court orders that question the thoroughness of FDA’s approval of the drug mifepristone more than 20 years ago. A panel of the U.S. Court of Appeals for the 5th Circuit did not go as far as a district court. They only undid the approval, but rolled back the agency’s more recent actions making the drug more accessible through the mail and approving its use later in pregnancy. Oh no, what are we to do now?
Last week, the Supreme Court said it would decide by midnight Wednesday whether to maintain full access to mifepristone while the case is appealed. It is the court’s most notable consideration of abortion rights since its landmark decision last June to overturn the guarantee of abortion rights provided in Roe v. Wade. Looks like the Supreme Court wants to have a little bit of fun.
“For nearly a quarter-century,” the anti-abortion doctors said in their filing on Tuesday, the FDA and the manufacturer of mifepristone “have brazenly flouted the law and applicable regulations, disregarded holes and red flags in their own safety data, intentionally evaded judicial review, and continually placed politics above women’s health.” Wow, sounds like we have a couple of rebels on our hands.
The government, pharmaceutical companies, and abortion-rights groups have all urged the court not to second-guess the expertise of the FDA, which relied on data from dozens of clinical trials when it approved mifepristone more than 20 years ago. They claim that the ruling in place will create confusion, uncertainty for abortion providers, and have devastating consequences for the pharmaceutical industry’s ability to bring new drugs to market. Sounds like they’re all in agreement, which is rare.
Further complicating the legal situation, a federal judge in Washington state issued a ruling in a separate lawsuit directing the FDA not to make any changes to the availability of mifepristone in 17 states, and the District of Columbia. Oh my, what a game of ping pong.
But the anti-abortion groups said under the 5th Circuit’s “reasonable” order, “women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use.” Well, at least something is still accessible.
In its filing, the manufacturer of mifepristone, Danco Laboratories, said affirming the 5th Circuit order would abandon the Supreme Court’s assurance last June that it was returning the issue of abortion to the states. “Allowing the Fifth Circuit’s opinion to stand eviscerates the sovereign authority of States that wish to expand and protect access to medication abortion in their jurisdictions,” wrote Jessica Ellsworth, the lead attorney for Danco. Oh, the drama!
The company was supported by amicus briefs from other companies. GenBioPro, the only generic manufacturer of mifepristone, told the court it would be forced to halt operations under the 5th Circuit’s ruling, which overturned FDA regulatory actions beginning in 2016. GenBioPro received FDA approval for its generic application in 2019. Looks like this ruling is creating a mess.
Last week, the Supreme Court put the 5th Circuit opinion on hold temporarily. The cases are FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine. This is a developing story. It will be updated. Oh boy, this sounds like it’ll be a fun ride!
Serious News: washingtonpost
