What Is Expanded Access ?
For More Detailed Information About Our “Emergency Use” Expanded Access Policy
We encourage patients that are considering participation in any of the available Expanded Access methods of investigational treatment, to visit the FDA’s website for additional information at https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients#what-is-it.
Please watch this video for more information:
Expanded Access Information For Patients
As expressed by the FDA Verbatim
“What is expanded access?
Investigational medical products are investigational drugs, biologics or medical devices that are being tested to see whether they are safe and effective. This means that these products have not yet been approved or cleared by the FDA and the FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause serious side effects that were not expected.
When seeking expanded access to an investigational medical product, it is critical that you and your licensed physician (typically your doctor, but not all doctors or healthcare providers are licensed physicians) consider all possible risks.
Whenever possible, an investigational medical product should be used as part of a clinical trial. However, there are times when it is not possible for a patient to be a part of a clinical trial (e.g., that there are no ongoing trials, a patient may not have access to a clinical trial or may not be eligible for the clinical trials, distance to get to a trial prevents access). In those circumstances, expanded access may be the only way for a patient to receive an investigational medical product.
FDA is committed to increasing awareness about the expanded access process and the procedures for getting access to investigational medical products. It is important to note that, even if you meet the criteria under the law and FDA regulations, the licensed physician, the Institutional Review Board (IRB), and the company all need to agree that expanded access is appropriate for you in order for you to receive the investigational medical product. In addition, there may be costs not covered by third-party payers such as private insurance or Medicare.”
What are the roles and responsibilities under the FDA’s Expanded Access Program
When seeking expanded access to an investigational medical product, it is critical that the patient and his/her physician consider all possible risks.
Investigational medical products have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Whenever possible, an investigational medical product should be used as part of a clinical trial. However, if patient enrollment is not possible (e.g., patient ineligibility, lack of ongoing clinical trials) or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational medical product.
Patients should therefore consult with their licensed physician to explore and determine what alternative options are available to them.
Licensed Physicians, In agreeance with providing the patients treatment that work in the industry (e.g., medical developer), file their paperwork with the FDA and IRB for the various or specific expanded access request types. They are responsible for the patients care and reporting.
The “Company” (In the Medical Industry), that is willing to provide the investigational medical product and either or submits the expanded access request to the FDA, which allows the FDA to cross-reference their IND (investigational drug and biologics) or IDE (investigational medical devices) on behalf of the expanded access sponsor-investigator through the use of a letter of authorization, or they provide all necessary investigational medical product information for the sponsor-investigator to submit to support an expanded access request.
Investigational Review Board (IRB), reviews expanded access protocol and consent to ensure that the patient is informed about the nature of the treatment.
The FDA (Food And Drug Administration), Receives and Reviews the expanded access request to determine aif the treatment protocol may proceed.
As Stated in the Column above, The Expanded access is a ptoential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical treatment that has not been approved by the FDA ourside of clinical trials when no comparable or satisfactory alternative therapy options are available through one of the three mechanisms:
- Emergency Use
- Compassionate Use (or Individual Patient/Smal Group Access)
- Treatment Investigational Device Exemption (IDE)
For more detailed information please visit the FDA here.