FDA accelerates approval process for rare disease therapies despite safety concerns The agency is imposing excessive regulations on Laboratory Developed Tests (LDTs), stifling innovation, limiting patient access to critical diagnostics (e.g., heavy metal, genetic and nutritional tests) and overriding CMS authority—potentially endangering public health. The FDA is eliminating mandatory clinical trials for experimental gene-editing and RNA-based treatments, relying instead on weak biomarkers and anecdotal evidence (like the “Baby KJ” case), risking another opioid or COVID vaccine-style disaster. The FDA, heavily influenced by pharmaceutical lobbyists, is slashing approval timelines for biosimilars and gene therapies while ignoring long-term risks—mirroring past failures like fast-tracked…