The "Right to Try" and FDA's Expanded Access pathways are intended to allow patients with severe illnesses to access unapproved treatments. However, these programs are rarely utilized because biotech companies, which fund drug development through investor capital, perceive the risk of lawsuits or negative trial outcomes as too high. The potential reward for providing access is minimal, as companies can only charge "at cost," creating a poor risk-reward balance that discourages participation. AI
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RANK_REASON The article discusses the ineffectiveness of existing policy pathways for accessing unapproved drugs, analyzing the reasons behind their low utilization.