FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Patient Advocates Seek Public Hearing to Examine Court-Ordered Drug Restrictions

April 13, 2018

A group of hemophilia patients and activists petitioned the FDA to hold a public hearing on court-ordered drug restrictions after an intellectual property suit filed by Shire requested restricted access for the hemophilia medication Hemlibra (emicizumab-kxwh).

The petition specifically urges the FDA to hold a public hearing to investigate the effects of “commerce-driven, court-ordered, drug access restrictions” on the U.S. medical system, particularly concerning the effect of court-ordered restrictions on patient access to new therapies and drug development.

The FDA’s drug research development, approval and drug testing processes are threatened by a new legal approach that would deny access to approved drugs based on non-medical issues, the petition claimed.

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