Expanded Access Programs
An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting. An EAP can also be called a Managed Access Program (MAP), Early Access Program, or Compassionate Use Program (CUP).
To be eligible for expanded access use of an investigational drug, a patient must be suffering from a serious or life-threatening illness and must have no other viable treatment options available to them. Fundamentally, there must be an unmet clinical need.
A patient may be interested in trying an investigational drug through expanded access if:
- There are no approved drugs available to treat the patient’s condition.
- If there are approved drugs available to treat the patient’s condition, the patient has tried them all and they have been ineffective.
- The patient does not meet the access/eligibility criteria for any available clinical trials
The above are the basic regulatory requirements for an EAP. However, pharmaceutical companies may include additional eligibility criteria. These criteria should be included in the EAP policy on a company’s website.
If you are looking for information on how to access an approved product that is available in a country outside of your own, please see our NPP page.