Step 1: Determine Eligibility
Before starting the application process, patients and physicians must ensure the patient qualifies for an EAP. Typical eligibility criteria include:- Diagnosis of a serious or life-threatening condition.
- Lack of alternative treatment options.
- Ineligibility for clinical trials due to geographic, medical, or logistical constraints.
- A physician’s determination that the investigational drug’s potential benefits outweigh its risks.
Step 2: Consult with a Physician
The patient’s treating physician plays a crucial role in the application process. Physicians must:- Confirm the patient’s eligibility.
- Identify a suitable investigational drug.
- Communicate with the drug manufacturer to confirm the drug’s availability for Expanded Access.
Step 3: Contact the Drug Manufacturer
Manufacturers are not obligated to provide investigational drugs through EAPs. Physicians should:- Reach out to the drug manufacturer to request access.
- Provide details about the patient’s condition and the intended use of the drug.
- Obtain the manufacturer’s agreement to supply the drug if the request is approved.
Step 4: Submit an Application to the FDA
If the manufacturer agrees to provide the drug, the physician must submit an Expanded Access application to the FDA. The application typically includes:- Form FDA 3926: A streamlined form specifically for Expanded Access requests.
- Patient’s medical history: Details about the diagnosis, previous treatments, and current condition.
- Rationale for the request: Explanation of why the investigational drug is appropriate for the patient.
- Informed consent form: Signed by the patient or their legal representative.
Step 5: Obtain IRB Approval
Before treatment can begin, the application must be reviewed by an Institutional Review Board (IRB) to ensure ethical standards are met. The IRB evaluates:- The risks and benefits of the investigational drug.
- The adequacy of the informed consent process.
Step 6: Administer the Treatment
Once all approvals are in place, the drug can be administered. The treating physician is responsible for:- Monitoring the patient’s response to the treatment.
- Reporting any adverse events to the FDA and the drug manufacturer.
Key Considerations for Patients and Caregivers
- Cost: Investigational drugs are typically provided for free, but patients may incur costs for administration and monitoring.
- Timelines: The process can take weeks to months, depending on the complexity of the case.
- Uncertainty: As the drugs are still investigational, their safety and efficacy are not fully established.
How Right2Hope Can Help
Right2Hope simplifies the EAP application process by:- Providing resources and guidance for patients and physicians.
- Connecting patients with experienced providers who understand EAP requirements.
- Advocating for timely responses from manufacturers and regulatory bodies.