The biotech industry has long operated on a simple premise: FDA-regulated, evidence-based science determines how medicines reach patients, not litigation. That premise was already tested in an earlier Texas case challenging mifepristone’s FDA approval — an unprecedented effort to unwind decades of scientific review through the courts. It is now, once again, under strain.
On Friday, the 5th Circuit Court of Appeals reinstated an in-person dispensing requirement for mifepristone, a medication that has been used safely by millions for more than two decades. The drug manufacturer, Danco, appealed to the Supreme Court within hours and on Monday morning, SCOTUS granted one-week stay halting the order. In other words, mifepristone is available again through the mail and at pharmacies — but it’s unclear for how long that will be true. And it signals that even well-established, FDA-approved medicines are vulnerable to judicial override of FDA regulatory decisions.
Read the rest…
