The FDA approves requests to use non-approved medications 99% of the time. When you hear about someone unable to access an experimental drug, it is almost alway

The FDA approves requests to use non-approved medications 99% of the time. When you hear about someone unable to access an experimental drug, it is almost always because the pharmaceutical company does not want to make the drug available early (for various reasons). > At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. http://healthaffairs.org/blog/2014/07/31/individual-patient-expanded-access-developing-principles-for-a-structural-and-regulatory-framework/ http://healthaffairs.org/blog/2014/07/31/individual-patient-...