FDA reduces paperwork to help patients access experimental drugs

The FDA eliminated some paperwork physicians must complete to obtain experimental drugs for patients with life-threatening illnesses that don't respond to standard therapies.


The regulator's compassionate use policy allows patients with incurable diseases to attempt to extend their lives by taking experimental drugs not yet approved by the FDA.


In response to concerns regarding physicians being deterred from applying for compassionate use due to the application's complicated nature, the FDA recently simplified the document by creating a patient-specific format and scaling back the number of questions from 26 to 11.


The policy first requires physicians to obtain a letter of authorization from the drug's manufacturer. Approval is voluntary and some manufacturers reject requests due to possible liability if the drug harms the patient.


Once a physician earns permission from the drug manufacturer, physicians file the newly amended application through the FDA. Only 14 out of 1,430 applications were rejected in 2015.


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