Tag

Rems

All articles tagged with #rems

SCOTUS faces a new mifepristone showdown as Fifth Circuit challenges loom
politics3 hours ago

SCOTUS faces a new mifepristone showdown as Fifth Circuit challenges loom

Two pharma-backed cases—Danco Laboratories v. Louisiana and GenBioPro v. Louisiana—bring a new Supreme Court reckoning over mifepristone, the Fifth Circuit’s standing theory, and what relief a federal court may grant that could upend the FDA’s REMS and mail‑order access. The Court’s course may mirror its Alliance ruling, potentially preserving access while the policy framework evolves, but the decision remains uncertain amid abortion politics and jurisdiction questions.

FDA Advisors Recommend Ending Clozapine REMS Program
health1 year ago

FDA Advisors Recommend Ending Clozapine REMS Program

Two FDA advisory panels have recommended eliminating the Risk Evaluation and Management Strategy (REMS) for clozapine, an antipsychotic drug used for treatment-resistant schizophrenia, citing that the current restrictions hinder access to the medication. While clozapine can cause severe neutropenia, the panels argue that the REMS requirements are overly burdensome and not necessary for safe use. Public testimony highlighted the negative impact of REMS on patient access, with many advocating for its removal to improve treatment availability.