Expanded Access Programs Need FDA Policy Changes To Really Expand
Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.
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Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.
Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.
One of the faces of FDA's effort to recruit senior leaders from outside its walls has decided to return to industry.