FDA Simplifies ‘Compassionate Use’ Process

Published February 11, 2015

This is good news for patients facing terminal illnesses:

FDA seeks faster patient access to experimental drugs

The Food and Drug Administration wants to dramatically simplify and speed up the application process for access to investigational drugs.

The agency Wednesday introduced new draft guidance (PDF) that includes a new application form for physicians to apply for experimental drugs not yet approved by the FDA under its expanded access program.

Dr. Peter Lurie, the FDA’s associate commissioner for public health strategy and analysis, wrote in a blog post that the new application form would streamline the process and cut the amount of time needed to complete an application from the current 100 hours to just 45 minutes…

A big part of the reason the FDA is making this change, according to the story, is the popularity and expansion of ‘Right to Try’ laws that have passed in several states. Leading the charge on these laws has been the our friends at the Goldwater Insitute, a free-market think tank in Arizona.