Frequently Asked Questions

Category:
Costs

In general, regulations limit fees to the cost of manufacturing.  Drug manufacturers vary by whether they waive all costs.  IRB fees may apply.  There may be hospital costs related to the cost of the drug or monitoring.In general, insurance companies will not pay for treatment that has not demonstrated a treatment benefit in clinical trials.

General

The 21st Century Cures Act passed in December 2016 requires transparency on Expanded Access (EA) policies and whom to contact for EA requests.

Compliance with the FDA Final Rule effective February 2017 requires a unique NCT for any Phase 2/3 drug where expanded access may be provided.

Drug manufacturers will insure that the investigational drug is shipped to the physician in the most expedient manner.

When a clinical trial is not an option, either because a patient does not qualify or perhaps there is no clinical trial, a physician may be able to request access to an investigational drug through a process called compassionate use.  At the Food and Drug Administration this is formally referred to as Expanded Access and other countries refer to this using different terminology.  At Early Access Care we refer to this as Early Access.