One federal judge ruled the FDA’s approval of mifepristone is invalid. Another ordered the FDA not to change the pill’s availability. What happens next?
Just one hour after a federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration’s approval of the widely-used abortion pill mifepristone, a federal judge in Washington state issued a ruling in a separate case that ordered the FDA to keep the pill available in the 18 states involved in the suit.
Confusion ensued.
For now, the drug remains available as the Texas judge, Trump-appointee Matthew J. Kacsmaryk, stayed his order for one week to allow the FDA time to appeal.
The Justice Department filed a notice that it will appeal the Texas ruling to the Fifth Circuit appeals court almost immediately. That court historically leans conservative in its interpretations and rulings.
But due to the conflicting rulings, it could now seek an emergency review before the Supreme Court.
Ameet Sarpatwari, a lawyer, said the conservative Supreme Court justices may not lean the way commentators would expect due to “the sort of incredible disturbance of a district judge’s national injunction coupled with the extreme volatility that that’s going to lead to in the pharmaceutical market.”
Experts say Judge Kacsmaryk’s decision seems to be the first time a court ordered a drug’s approval to be revoked over the FDA’s objections.
Mifepristone is used in combination with misoprostol to end pregnancies that are less than ten week old. Misoprostol remains approved for use on its own and is not the subject of any current legal proceedings.
Kacsmaryk’s ruling could pave the way for legal challenges to other drugs, such as morning-after pills or unrelated drugs like vaccines.
Due to the broad implications federally and commercially, some legal analysts expect the Supreme Court justices to more carefully consider an order that would undercut the FDA’s authority.
I would HOPE the “impact” to big Pharma is not a consideration in any court’s consideration of the Constitutionality of the manner of its “approval”. I certainly shouldn’t be a consideration in FDA approval or rejection either, but all too often it s, as much f FDA funding comes from big Pharma, a conflict of interest f ever there was one! But, in terms of Constitutionality, the FDA itself is unconstitutional, as are most of the bureaucratic agencies in DC!