Last mentioned: 5d ago
Initial Inquiry
The Senator's office begins requesting data on DMD drug approval timelines and internal CBER deliberations.
Investigation Announced
Sen. Ron Johnson announces a formal probe into the FDA's handling of rare disease drug applications.
Commissioner Meeting
Johnson meets with FDA Commissioner Marty Makary to discuss specific biologic therapy rejections.
Senator Ron Johnson (R-Wisc.) has launched an investigation into the FDA's regulatory hurdles for rare disease treatments, specifically targeting biologics for Duchenne muscular dystrophy. The probe follows a direct meeting with FDA Commissioner Marty Makary and signals a significant escalation in political pressure on the agency's approval standards.
FDA Commissioner Marty Makary is reportedly attempting to hire Dr. Tracy Beth Hoeg to lead a new initiative focused on antidepressant safety. The move is tied to a proposed 'bold new warning' for SSRIs and SNRIs, potentially addressing persistent side effects that have long been a point of contention between regulators and the pharmaceutical industry.