The Food and Drug Administration has reduced an obstacle from its compassionate use policy, streamlining paperwork that physicians must submit to obtain experimental drugs for patients with life-threatening illnesses.
Doctors will now file an application for FDA approval that contains just 11 questions, 15 fewer than the old form. They should be able to complete this new version in 45 minutes, the FDA said. The new form is simpler because it was designed for individual patients, replacing an all-purpose format that had been used by doctors acting on behalf of individuals or groups of patients…
Doctors still must first obtain a letter of authorization from that drug’s manufacturer. The FDA can’t compel drugmakers to grant permission. Manufacturers might reject requests because they’re worried about liability if the drug causes harm or they might consider the drug unsuited for a particular patient.